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MDCG Pre-Registration Assessment study materials
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MDCG Pre-Registration Assessment practice questions

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Question 1EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under Regulation (EU) 2017/745, which body is responsible for adopting the implementing acts and delegated acts needed for the uniform application of the MDR, including the designation and oversight of notified bodies?

  1. The national competent authorities of each Member State
  2. The Medical Device Coordination Group
  3. The notified bodies themselves
  4. The European Commission Correct answer.

Explanation

The MDR confers implementing and delegated powers on the European Commission, which adopts the relevant acts, for example on notified body designation codes and on the common specifications. The MDCG is only an advisory and coordinating body that assists the Commission and does not itself adopt binding acts. National competent authorities implement and enforce the Regulation domestically.

Question 2EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which statement correctly describes the relationship between Regulation (EU) 2017/746 (IVDR) and Regulation (EU) 2017/745 (MDR)?

  1. They are two separate regulations with parallel but distinct scopes, one for in vitro diagnostic medical devices and one for other medical devices Correct answer.
  2. The IVDR applies only to devices that are also covered by the MDR, adding extra requirements
  3. The IVDR is a delegated act adopted under the MDR that covers only companion diagnostics
  4. The MDR repealed and replaced the IVDR when it became applicable in May 2021

Explanation

The MDR and IVDR are two autonomous regulations with separate legal bases and scopes: the MDR governs general medical devices and the IVDR governs in vitro diagnostic medical devices. They share structural principles such as the risk-based classification and conformity assessment routes but neither is subordinate to the other. A device falls under one regime, not both.

Question 3EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer places a Class IIa device on the EU market. Which conformity assessment route does the MDR generally permit, assuming no common specifications or special rules apply?

  1. Self-certification with a signed declaration of conformity and no notified body involvement
  2. A full quality management system audit by a notified body plus assessment of the technical documentation Correct answer.
  3. Assessment by a national competent authority rather than a notified body
  4. Assessment of the technical documentation by a notified body, without a full quality management system audit

Explanation

For Class IIa devices the MDR generally requires the manufacturer to operate a quality management system assessed by a notified body and to have the technical documentation assessed, with sampling-based review of documentation for certain devices. Annex IX and Annex XI provide the applicable conformity assessment routes. Class IIa devices cannot be self-certified.

Question 4EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which document does the MDCG issue to give guidance on the interpretation and application of the MDR and IVDR?

  1. Notified body certificates, which are issued per manufacturer and product
  2. MDCG guidance documents, which are not legally binding but reflect the agreed position of the MDCG and Commission services Correct answer.
  3. Delegated regulations that become directly applicable in all Member States once adopted
  4. Harmonised standards cited in the Official Journal, which confer a presumption of conformity

Explanation

MDCG guidance documents are produced by the Medical Device Coordination Group, often with Commission services, to promote a consistent interpretation of the MDR and IVDR across the EU. They are not legally binding in the way a regulation is, but they reflect the coordinated position of the authorities and are relied on in practice. Their status differs from harmonised standards and from individual notified body certificates.

Question 5EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under the MDR, what is the function of harmonised standards whose references have been published in the Official Journal of the European Union?

  1. They are binding only on notified bodies and not on manufacturers
  2. They replace the general safety and performance requirements for the devices they address
  3. They create a presumption of conformity with the requirements they cover, which the manufacturer may rebut Correct answer.
  4. They are mandatory technical specifications that manufacturers must meet to place a device on the market

Explanation

Applying a harmonised standard whose reference is published in the Official Journal gives a presumption of conformity with the general safety and performance requirements it covers. The presumption can be rebutted if the manufacturer cannot demonstrate conformity, and using the standard is not compulsory. Manufacturers may use other technical solutions provided they demonstrate equivalent conformity.

Question 6EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer's device is classified as Class I under the MDR but is supplied sterile. What does this mean for the conformity assessment?

  1. The manufacturer needs only a declaration from the sterilisation subcontractor
  2. The manufacturer may self-certify because all Class I devices are exempt from notified body involvement
  3. The device must be reclassified as Class IIb because sterility raises the risk class
  4. A notified body must be involved for the aspects relating to the sterile condition of the device Correct answer.

Explanation

Class I devices that are placed on the market sterile, have a measuring function or are reusable surgical instruments require notified body involvement for the aspects concerned, such as the sterile condition. The rest of the conformity assessment for such devices remains the manufacturer's responsibility. Sterility alone does not change the risk class of the device.

Question 7EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following is a general safety and performance requirement that applies to devices under Annex I of the MDR?

  1. Devices must be designed and manufactured so that they perform as intended and are safe for the patient and user Correct answer.
  2. Devices must always be CE marked before clinical evaluation is completed
  3. Devices must be sold at a price approved by a notified body
  4. Devices must be manufactured in an EU Member State

Explanation

Annex I of the MDR sets out the general safety and performance requirements, including the principle that devices must achieve their intended performance and be designed and manufactured to be safe. These requirements are risk-based and apply to all devices, with the manufacturer responsible for demonstrating conformity. They do not impose manufacturing location, pricing or sequencing rules of the kind suggested in the other options.

Question 8EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What is the principal role of a notified body in the EU medical device system?

  1. To set the classification rules that apply to each device category
  2. To act as the importer of record for devices entering the EU
  3. To perform conformity assessment activities for which it has been designated, such as QMS audits and technical documentation review Correct answer.
  4. To grant marketing authorisations for medical devices on behalf of the European Commission

Explanation

A notified body is an independent conformity assessment body designated by a Member State under the MDR to carry out the assessment tasks within its scope of designation. It audits quality management systems, reviews technical documentation and issues certificates where the requirements are met. It does not grant marketing authorisations, set classification rules or act as importer.

Question 9EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A device is intended to be used to diagnose a life-threatening disease. Under the MDR classification rules, which factor is most relevant to determining whether it falls into a higher risk class?

  1. Whether the device is intended for use in direct contact with the heart or central circulatory system Correct answer.
  2. Whether the device is manufactured outside the European Union
  3. Whether the manufacturer already holds a certificate for a different device
  4. Whether the device is sold only to healthcare professionals

Explanation

Annex VIII of the MDR classifies devices by intended purpose and risk, and devices intended for direct contact with the heart or central circulatory system are assigned a higher class under the specific rules. Manufacturing location, existing certificates for other devices and the sales channel do not determine the class. The classification follows the intended use and the potential harm.

Question 10EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which EU legal instrument originally introduced the requirement for a unique device identification (UDI) system for medical devices?

  1. Regulation (EU) 2019/1020 on market surveillance
  2. Regulation (EC) No 1907/2006 (REACH)
  3. Directive 93/42/EEC on medical devices
  4. Regulation (EU) 2017/745 on medical devices Correct answer.

Explanation

The MDR introduced the UDI system for medical devices in the EU, with implementing rules on assignment and registration in Eudamed. The earlier Medical Devices Directive did not contain a UDI system of this kind. REACH and the market surveillance regulation address different subject matter.

Question 11EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What is Eudamed, as established under the MDR?

  1. A notified body accreditation scheme run by the European Commission
  2. A harmonised standard for software as a medical device
  3. A fund that finances clinical investigations in the EU
  4. A European database on medical devices that integrates registration of devices, economic operators, certificates and vigilance information Correct answer.

Explanation

Eudamed is the European database on medical devices set up under the MDR, bringing together modules for device registration, economic operator registration, certificates, clinical investigations and vigilance. It is a transparency and information-exchange tool for authorities and the public. It is not an accreditation scheme, a standard or a funding instrument.

Question 12EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer becomes aware of a serious incident involving its CE-marked device in France. Under the MDR, what is the primary obligation?

  1. Report the serious incident to the competent authority of the Member State where the incident occurred, within the timeframes set by the Regulation Correct answer.
  2. Report only to the notified body that issued the certificate
  3. Report only to the importer, who then decides whether to notify anyone
  4. Wait until the annual periodic safety update report is due before reporting

Explanation

Under the MDR vigilance provisions, the manufacturer must report serious incidents to the competent authority of the Member State where the incident occurred, within the timeframes set in the Regulation. Notified bodies and importers may need information, but they are not the primary recipient of the vigilance report. Reporting cannot be deferred to the PSUR cycle.

Question 13EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following best describes the purpose of the periodic safety update report (PSUR) under the MDR?

  1. To provide a consolidated analysis of the post-market surveillance data and benefit-risk assessment for a device at defined intervals Correct answer.
  2. To certify that the device continues to meet the general safety and performance requirements
  3. To record every complaint received about the device
  4. To replace the technical documentation for the device after CE marking

Explanation

The PSUR summarises and analyses the results of post-market surveillance, including the benefit-risk determination, and is prepared at intervals that depend on the device class. It is part of the post-market surveillance system rather than a substitute for technical documentation. It does not itself certify conformity.

Question 14EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under the MDR, which economic operator is responsible for verifying that a device bears the CE marking and that the required EU declaration of conformity and instructions are present before making it available on the market?

  1. The distributor Correct answer.
  2. The manufacturer's contract manufacturer
  3. The authorised representative
  4. The notified body

Explanation

Distributors must verify, before making a device available, that it bears the CE marking, that the EU declaration of conformity has been drawn up and that the required labelling and instructions are supplied. If they believe a device is non-compliant they must not make it available and must inform the manufacturer and authorities. The authorised representative and notified body have different roles.

Question 15EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A non-EU manufacturer wants to place devices on the EU market. Which requirement applies under the MDR?

  1. The manufacturer must transfer its quality management system to an EU notified body
  2. The manufacturer must appoint an authorised representative established in the EU Correct answer.
  3. The manufacturer must obtain a separate CE certificate from each national competent authority
  4. The manufacturer must establish a subsidiary in every Member State where it sells

Explanation

A manufacturer established outside the EU must appoint a single authorised representative established in the Union to act on its behalf for the obligations specified in the MDR. The authorised representative's details must appear on the device or its labelling and documentation. There is no requirement to establish subsidiaries in each Member State.

Question 16EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following statements about clinical evaluation under the MDR is correct?

  1. It is required only for Class III devices
  2. It may only be based on a new clinical investigation performed by the manufacturer
  3. It is a continuous process that must be updated throughout the device lifecycle using clinical data and post-market information Correct answer.
  4. It is a one-off exercise completed before the first CE marking and never revisited

Explanation

Clinical evaluation under the MDR is a planned and continuous process: the manufacturer assesses clinical data, including post-market clinical follow-up, and updates the evaluation throughout the device lifecycle. It can rely on existing literature and equivalent devices where justified, not only on new investigations. It applies to all classes, with depth proportionate to risk.

Question 17EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What is the main purpose of the MDCG guidance document on the qualification and classification of software under the MDR and IVDR?

  1. To help manufacturers and authorities determine consistently whether software qualifies as a medical device and how it should be classified Correct answer.
  2. To replace the classification rules in Annex VIII of the MDR
  3. To impose a mandatory certification scheme for all software used in healthcare
  4. To define the programming languages permitted for medical device software

Explanation

The MDCG software guidance aims at a consistent approach to deciding whether software falls within the definition of a medical device and, if so, how the classification rules apply. It supports interpretation by manufacturers and authorities and does not create new legal obligations. It does not prescribe programming languages or replace Annex VIII.

Question 18EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following devices is explicitly excluded from the scope of the MDR?

  1. A device used to control conception
  2. A surgically invasive device used to administer medicinal products
  3. A cosmetic contact lens without a medical purpose Correct answer.
  4. A device intended for the prediction of disease that is not an in vitro diagnostic device

Explanation

The MDR excludes products without an intended medical purpose that are listed in Annex XVI only where they are covered by that annex; a cosmetic contact lens without a medical purpose is not a medical device unless it falls within Annex XVI. The other examples are within the MDR's scope because they have a medical purpose or are specifically addressed. The distinction turns on intended purpose and the Annex XVI list.

Question 19EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under the MDR, what is the significance of a device being 'custom-made'?

  1. It can be placed on the market without any documentation
  2. It must be classified as Class III regardless of its intended purpose
  3. It is exempt from all general safety and performance requirements
  4. It is made specifically for a named patient or user and does not require a CE marking, subject to conditions in the Regulation Correct answer.

Explanation

Custom-made devices are made for a named patient or user under a prescription and are subject to specific conditions in the MDR, including documentation and, for certain classes, notified body involvement; they do not carry a CE marking. They remain subject to the general safety and performance requirements. Their classification follows the ordinary rules.

Question 20EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following statements about the MDCG's composition and function is accurate?

  1. It is a committee of the European Parliament with legislative powers over device regulation
  2. It is composed exclusively of notified body representatives
  3. It is chaired by a representative of the European Commission and brings together representatives of Member State competent authorities Correct answer.
  4. It is a private industry association that drafts standards for medical devices

Explanation

The MDCG is chaired by a representative of the European Commission and includes representatives of the Member State competent authorities, with observers in defined cases. Its function is coordination and advice on the uniform application of the MDR and IVDR. It is not a legislative body and not a private association.

Question 21EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer plans to conduct a clinical investigation in three Member States. Under the MDR, which mechanism is available for the coordinated assessment of the application?

  1. A separate independent approval by each Member State with no coordination
  2. Approval by the notified body in place of the Member States
  3. Automatic approval by the European Commission without national assessment
  4. A single coordinated assessment process involving the Member States concerned, with one Member State acting as coordinating Member State Correct answer.

Explanation

The MDR provides for a coordinated assessment procedure for clinical investigations involving more than one Member State, in which one Member State acts as the coordinating Member State and the others participate in the review. This replaces purely separate national reviews with a coordinated process. Notified bodies do not approve clinical investigations in place of Member States.

Question 22EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following describes the 'person responsible for regulatory compliance' (PRRC) under the MDR?

  1. A person within the manufacturer's organisation, or available to it, who holds the required qualifications and is responsible for compliance with specified regulatory obligations Correct answer.
  2. An employee of the competent authority who monitors the manufacturer
  3. A consultant who may be shared by any number of manufacturers without restriction
  4. An official of the notified body assigned to each manufacturer

Explanation

The MDR requires manufacturers, and authorised representatives, to have at least one person responsible for regulatory compliance who meets the qualification requirements in the Regulation. That person ensures compliance with obligations such as conformity assessment, technical documentation, vigilance and post-market surveillance. The role sits within the manufacturer's or authorised representative's organisation.

Question 23EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What does the 'state of the art' concept require of a manufacturer under the MDR?

  1. That the device is upgraded automatically whenever a new standard is published
  2. That the device is designed only to meet the minimum requirements of harmonised standards in force
  3. That the device uses the most recently patented technology available
  4. That the device is designed and manufactured taking account of generally acknowledged technological developments and best practice at the time Correct answer.

Explanation

Under Annex I the manufacturer must take account of the generally acknowledged state of the art, meaning the current technological possibilities and best practice, when designing and manufacturing the device. This is broader than merely following a harmonised standard, which may lag behind or differ from the state of the art. It does not require adopting every new patent or automatic upgrades.

Question 24EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following is true about the EU declaration of conformity for a device under the MDR?

  1. It must be renewed every year regardless of changes
  2. It is issued by the notified body after the QMS audit
  3. It is valid only if signed by a competent authority
  4. It is drawn up by the manufacturer and states that the applicable requirements of the Regulation have been fulfilled Correct answer.

Explanation

The EU declaration of conformity is a document drawn up by the manufacturer stating that the applicable requirements of the MDR have been met and taking legal responsibility for this. It accompanies the device and is part of the technical documentation. It is not issued by the notified body or a competent authority.

Question 25EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

How does the MDR treat devices that are also 'machinery' within the meaning of Directive 2006/42/EC?

  1. The manufacturer may choose which regime to apply
  2. The MDR applies in addition to the machinery directive, and the manufacturer must ensure that the device meets both sets of requirements where they apply Correct answer.
  3. The device must be registered only under the machinery directive
  4. The machinery directive prevails and the MDR does not apply

Explanation

Where a device also falls within the scope of other Union legislation, such as the Machinery Directive, the MDR applies in addition to that legislation and the manufacturer must satisfy both sets of applicable requirements. The MDR does not displace the other regime, nor does the manufacturer have a free choice between them. The declaration of conformity must reflect compliance with all applicable instruments.

Question 26EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under the MDR, which document must a manufacturer draw up and keep up to date for each device, describing the device, its intended purpose and the risk management approach applied?

  1. The certificate of free sale, which the manufacturer issues before CE marking
  2. The technical documentation, which includes Annex II elements such as device description, labelling and the risk management file Correct answer.
  3. The vigilance report, which is submitted to the notified body at least annually
  4. The periodic safety update report, which replaces the technical file for all risk classes

Explanation

Annex II of the MDR sets out the technical documentation that must accompany each device and be maintained throughout the lifecycle, covering description, intended purpose, labelling, design and manufacturing information and risk management. The PSUR and vigilance reporting are post-market obligations, not substitutes for the technical file.

Question 27EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer places a Class IIa device on the market. Under the MDR conformity assessment routes, which statement best describes the role of the notified body?

  1. The notified body issues the EU declaration of conformity on the manufacturer's behalf
  2. The notified body assesses the technical documentation and quality system and issues an EU technical documentation assessment certificate or quality system approval Correct answer.
  3. The notified body acts as the legal manufacturer and places the device on the market
  4. The notified body performs the classification of the device and assigns the risk class

Explanation

For Class IIa and above, a notified body must be involved in conformity assessment, typically assessing technical documentation and/or the quality management system and issuing the relevant certificate. The manufacturer, not the notified body, draws up the EU declaration of conformity and remains the legal manufacturer.

Question 28EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which statement accurately describes the legal status of MDCG guidance documents within the EU medical device framework?

  1. They are non-binding guidance agreed by Member State authorities that supports consistent interpretation of the MDR and IVDR Correct answer.
  2. They are binding regulations that create new obligations directly applicable to manufacturers
  3. They are opinions of the European Court of Justice that bind national courts
  4. They are international standards that confer presumption of conformity when applied

Explanation

MDCG guidance documents are prepared by the Medical Device Coordination Group, composed of Member State representatives and chaired by the Commission, and are intended to promote uniform interpretation and application of the MDR and IVDR. They are not legislation and do not themselves create binding legal obligations.

Question 29EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under the IVDR, which of the following is the correct classification basis for an in vitro diagnostic medical device intended to detect a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation?

  1. Class B
  2. Class D Correct answer.
  3. Class C
  4. Class A

Explanation

Annex VIII of the IVDR places devices intended to detect the presence of, or exposure to, a transmissible agent causing a life-threatening disease with a high or suspected high risk of propagation in Class D. Class D is the highest IVD risk class and requires notified body involvement with reference laboratory scrutiny.

Question 30EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What is the principal purpose of the Medical Device Coordination Group (MDCG) established under Article 103 of the MDR?

  1. To conduct unannounced audits of notified bodies
  2. To grant CE marking certificates to manufacturers directly
  3. To coordinate the consistent implementation of the MDR and IVDR across Member States and to advise the Commission on medical device matters Correct answer.
  4. To operate Eudamed and manage its database infrastructure

Explanation

Article 103 of the MDR establishes the MDCG to ensure a high level of protection of health and safety and the smooth functioning of the internal market by coordinating implementation and advising the Commission. It is composed of Member State representatives and chaired by the Commission.

Question 31EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer wishes to use a harmonised standard to demonstrate conformity with a general safety and performance requirement. What is the legal effect of applying that harmonised standard under the MDR?

  1. It replaces the need for a clinical evaluation
  2. It becomes mandatory for all manufacturers once cited in the Official Journal
  3. It automatically exempts the device from notified body assessment
  4. It confers presumption of conformity with the requirements covered by the standard, provided the reference has been published in the Official Journal Correct answer.

Explanation

Under Article 8 of the MDR, devices that are in conformity with applicable harmonised standards whose references have been published in the Official Journal are presumed to conform to the requirements covered by those standards. The presumption is rebuttable and does not remove other obligations such as clinical evaluation.

Question 32EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following best describes the scope of the IVDR compared with the MDR?

  1. The IVDR governs devices intended for the in vitro examination of specimens derived from the human body, while the MDR governs other medical devices Correct answer.
  2. The IVDR governs devices used in clinical investigations, while the MDR governs devices placed on the market
  3. The IVDR governs accessories, while the MDR governs the main devices
  4. The IVDR governs software only, while the MDR governs all hardware devices

Explanation

Regulation (EU) 2017/746 applies to in vitro diagnostic medical devices, defined as devices intended to examine specimens derived from the human body for diagnostic, monitoring or compatibility purposes. Regulation (EU) 2017/745 applies to other medical devices and their accessories.

Question 33EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What is the function of the 'summary of safety and clinical performance' (SSCP) under the MDR?

  1. It is the manufacturer's annual post-market surveillance report submitted to Eudamed
  2. It is a confidential document submitted only to the notified body as part of the technical file
  3. It is a publicly available summary written for the intended user and, where relevant, the patient, covering the device's safety and clinical performance Correct answer.
  4. It is the EU declaration of conformity for implantable devices

Explanation

Article 32 of the MDR requires the manufacturer to draw up an SSCP for implantable devices and Class III devices, validated by the notified body, and made publicly available. It summarises the clinical evaluation and post-market clinical follow-up for the intended user and, where relevant, the patient.

Question 34EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer of a Class III implantable device intends to rely on equivalence with another manufacturer's device to support clinical evaluation. Under the MDR, what condition must be met?

  1. The manufacturer must have sufficient access to the technical documentation of the equivalent device and demonstrate that the device is equivalent in technical, biological and clinical characteristics Correct answer.
  2. The manufacturer must show only that the devices share the same intended purpose
  3. The manufacturer must conduct a new clinical investigation in every case
  4. The manufacturer must obtain a certificate of equivalence from the European Commission

Explanation

Annex XIV of the MDR permits reliance on clinical data from an equivalent device only where there is sufficient access to the technical documentation and the device satisfies the three-part equivalence criteria: technical, biological and clinical characteristics. For implantable Class III devices, additional justification and consultation requirements apply.

Question 35EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Under the MDR, what is the primary purpose of the unique device identification (UDI) system?

  1. To serve as the manufacturer's quality management system certificate
  2. To replace the CE marking on the device label
  3. To enable traceability of devices and support post-market safety activities such as recall and vigilance Correct answer.
  4. To determine the risk classification of the device

Explanation

Article 27 of the MDR establishes the UDI system to enhance traceability and support post-market surveillance, vigilance and transparency. The UDI is additional to, not a replacement for, CE marking and classification.

Question 36EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following statements about the transitional provisions of the IVDR (Regulation (EU) 2017/746) is correct?

  1. The transitional provisions apply only to Class D devices
  2. Certain legacy devices may continue to be placed on the market until specified dates, subject to conditions such as a notified body application being lodged within the prescribed period Correct answer.
  3. Legacy devices may be placed on the market indefinitely provided the manufacturer self-certifies
  4. All in vitro diagnostic devices had to comply with the IVDR on the date of application without any transitional period

Explanation

The IVDR, as amended, provides transitional periods during which certain devices covered by a Directive certificate or declaration may continue to be placed on the market, conditional on requirements such as lodging a conformity assessment application with a notified body by the prescribed date. The conditions vary by risk class.

Question 37EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

What does the MDR require regarding the 'person responsible for regulatory compliance' (PRRC) for a manufacturer?

  1. The PRRC must be a qualified lawyer registered with a national bar
  2. The manufacturer must have at least one PRRC with the prescribed qualifications or experience available within its organisation Correct answer.
  3. The PRRC must be an employee of the notified body
  4. The PRRC must reside in every Member State where the device is sold

Explanation

Article 15 of the MDR requires manufacturers to have at least one person responsible for regulatory compliance who possesses the requisite expertise, demonstrated by qualifications or professional experience. The PRRC ensures compliance with regulatory obligations and is not required to be located in each Member State.

Question 38EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

A manufacturer intends to conduct a clinical investigation of a device in several Member States. Which mechanism does the MDR provide to simplify this process?

  1. A coordinated assessment procedure involving the Member States concerned, with a single application submitted through the electronic system Correct answer.
  2. An exemption from the requirement for informed consent in all participating states
  3. A single European Commission authorisation that replaces all national ethics approvals
  4. A mutual recognition scheme based on the manufacturer's own assessment

Explanation

Article 78 of the MDR allows a sponsor to submit a single application for a multi-country clinical investigation through the electronic system, with the Member States concerned coordinating their assessment. National ethics review and other national requirements may still apply.

Question 39EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

Which of the following is a general obligation of importers under the MDR?

  1. Drawing up the EU declaration of conformity on behalf of the manufacturer
  2. Verifying that the device bears the CE marking and that the manufacturer has drawn up the EU declaration of conformity before placing the device on the market Correct answer.
  3. Issuing the certificate of conformity for the device
  4. Conducting the clinical evaluation of the device

Explanation

Article 13 of the MDR requires importers to verify that the device bears the CE marking, that the EU declaration of conformity has been drawn up, that the manufacturer is identified and that labelling and instructions are present in the required languages. Importers must not place non-compliant devices on the market.

Question 40EU Medical Device Regulatory Framework (MDR 2017/745, IVDR 2017/746, MDCG Guidance Structure)

How does the MDR treat a device that also falls within the scope of Directive 2006/42/EC on machinery?

  1. The device is excluded from both instruments
  2. The manufacturer may choose which single legal instrument to apply
  3. The MDR applies in addition, and the manufacturer must also meet the applicable essential health and safety requirements of the machinery directive Correct answer.
  4. The machinery directive prevails and the MDR does not apply

Explanation

Article 1 of the MDR provides that where a device also falls within the scope of Directive 2006/42/EC, the MDR applies in addition to that directive, and the essential health and safety requirements of the directive apply insofar as they are more specific. The manufacturer must address both sets of requirements.

Question 41Device Classification, Conformity Assessment Routes and Notified Body Involvement

Under Regulation (EU) 2017/745, which classification is assigned to a device intended to be used to modify the heart rhythm by delivering energy directly to the heart?

  1. Class IIa
  2. Class I, sterile
  3. Class III Correct answer.
  4. Class IIb

Explanation

Annex VIII, Rule 6 places devices intended to control, monitor or directly influence the performance of active implantable devices or devices delivering energy to the heart in Class III. Directly influencing cardiac rhythm with delivered energy is the classic trigger for the highest class.

Question 42Device Classification, Conformity Assessment Routes and Notified Body Involvement

A manufacturer's device is correctly classified as Class I and is not sterile, has no measuring function and is not a reusable surgical instrument. What is the appropriate conformity assessment route?

  1. EU type-examination followed by production quality assurance
  2. Full quality assurance under Annex IX with notified body audit
  3. Self-declaration with a technical documentation assessment by a notified body
  4. Self-declaration under Annex IV without notified body involvement Correct answer.

Explanation

For low-risk Class I devices outside the sterile, measuring and reusable surgical categories, the manufacturer can draw up technical documentation and issue the EU declaration of conformity without a notified body. Annex IV documentation plus the Annex I conformity assessment obligations are self-assessed.

Question 43Device Classification, Conformity Assessment Routes and Notified Body Involvement

Which body issues the EU technical documentation assessment certificate that supports a Class III device's conformity assessment?

  1. A competent authority of the manufacturer's member state
  2. An EU reference laboratory
  3. A notified body designated under Regulation (EU) 2017/745 Correct answer.
  4. The European Commission

Explanation

Notified bodies are the conformity assessment bodies designated under the Regulation and are the entities that assess technical documentation and issue the relevant certificates. Competent authorities supervise the system but do not issue these certificates.

Question 44Device Classification, Conformity Assessment Routes and Notified Body Involvement

A manufacturer wants to use Annex IX full quality assurance for a Class IIb device. Which element is required in addition to the quality management system assessment?

  1. An annual audit by the competent authority instead of the notified body
  2. A separate EU type-examination certificate for every device in the group
  3. A certificate of free sale from the manufacturer's country of origin
  4. An assessment of the technical documentation for at least one representative device per generic device group Correct answer.

Explanation

Annex IX combines assessment of the quality management system with an assessment of the technical documentation on a representative basis for each generic device group. The notified body must review the documentation to confirm conformity with the applicable requirements.

Question 45Device Classification, Conformity Assessment Routes and Notified Body Involvement

Which classification rule in Annex VIII addresses devices incorporating a medicinal substance that has an ancillary action on the body?

  1. Rule 21
  2. Rule 12 Correct answer.
  3. Rule 8
  4. Rule 14

Explanation

Rule 12 covers devices that incorporate, as an integral part, a substance which, if used separately, would be considered a medicinal product and which has an ancillary action. Such devices are generally Class III.

Question 46Device Classification, Conformity Assessment Routes and Notified Body Involvement

Which conformity assessment route allows a notified body to issue an EU type-examination certificate for a Class IIa device?

  1. Annex IV self-declaration
  2. Annex VII declaration of conformity without assessment
  3. Annex II technical documentation only
  4. Annex X type-examination combined with Annex XI production quality assurance Correct answer.

Explanation

For Class IIa devices, Annex X (EU type-examination) can be combined with Annex XI (production quality assurance) as one available route. The notified body examines a representative sample and certifies the type.

Question 47Device Classification, Conformity Assessment Routes and Notified Body Involvement

A manufacturer places a Class I device on the market that is intended to be sterilised before use but is supplied non-sterile. How does this affect notified body involvement?

  1. A notified body must perform full quality assurance under Annex IX
  2. No notified body is required because the device remains Class I
  3. The device is automatically reclassified as Class IIb
  4. A notified body must assess the aspects relating to the establishment of sterility Correct answer.

Explanation

Class I devices that are supplied sterile or have a measuring function or are reusable surgical instruments require notified body involvement for those specific aspects. For a non-sterile device intended to be sterilised before use, the sterility aspect is not established by the manufacturer at supply.

Question 48Device Classification, Conformity Assessment Routes and Notified Body Involvement

Which of the following best describes the purpose of an EU type-examination certificate issued under Annex X?

  1. It certifies that the device has been granted a marketing authorisation
  2. It certifies that the manufacturer's quality system meets Annex IX requirements
  3. It certifies that the device is eligible for reimbursement in member states
  4. It certifies that a representative sample of the device conforms to the applicable provisions of the Regulation Correct answer.

Explanation

EU type-examination is a procedure by which a notified body ascertains and certifies that a representative sample of the production in question conforms to the relevant requirements. It addresses the device type, not the manufacturer's full quality system.

Question 49Device Classification, Conformity Assessment Routes and Notified Body Involvement

A manufacturer is assessing a device that is intended to be used for direct contact with the heart or central circulatory system during surgery. Which classification outcome applies under the classification rules for invasive devices?

  1. Class IIb
  2. Class I
  3. Class III Correct answer.
  4. Class IIa

Explanation

Under Rule 7, surgically invasive devices intended specifically for use in direct contact with the heart, central circulatory system or central nervous system are classified as Class III. This reflects the high risk of harm from such contact.

Question 50Device Classification, Conformity Assessment Routes and Notified Body Involvement

Which statement correctly describes the role of a notified body in the assessment of a Class III device under Annex IX?

  1. It replaces the manufacturer's post-market surveillance obligations
  2. It grants the CE marking directly to the device
  3. It issues the EU declaration of conformity on behalf of the manufacturer
  4. It audits the manufacturer's quality system and assesses technical documentation for representative devices Correct answer.

Explanation

Under Annex IX the notified body assesses the quality management system and the technical documentation on a representative basis. The manufacturer remains responsible for the declaration of conformity and for post-market surveillance.