MDCG Pre-Registration Assessment flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

MDR application date

The Medical Device Regulation (EU) 2017/745 has applied since 26 May 2021, replacing the MDD 93/42/EEC and AIMDD 90/385/EEC.

IVDR application date

The In Vitro Diagnostic Regulation (EU) 2017/746 has applied since 26 May 2022, replacing IVDD 98/79/EC.

MDCG guidance legal status

MDCG guidance is non-binding but is used by notified bodies and competent authorities as the assessment benchmark; deviations must be justified in the technical documentation.

Authorised representative mandate

A non-EU manufacturer must appoint an EU authorised representative whose written mandate covers regulatory liaison, incident reporting support, and access to technical documentation.

MDR Rule 11 software

Software providing information for diagnostic or therapeutic decisions is Class IIa; if death or irreversible deterioration is possible, Class IIb; if likely, Class III.

IVDR Rule 3 transmissible agents

IVDs intended to detect, diagnose, or monitor transmissible agents are Class D when they detect a life-threatening disease with high or suspected high risk of propagation.

Class I sterile subclass

Class I devices that are sterile are subclass Is and require notified body involvement for the sterility aspect only; the manufacturer remains responsible for the rest.

Duration categories

Transient is less than 60 minutes; short-term is 60 minutes to 30 days; long-term is more than 30 days. Duration combines with invasiveness to set the class.

Class IIa conformity route

Class IIa devices use Annex IX (QMS plus technical documentation assessment) or Annex XI Part A (production quality assurance) with Annex IX Section 4 sampling.

Class III conformity route

Class III devices use Annex IX (QMS plus technical documentation assessment of each device) or Annex X type-examination combined with Annex XI Part B.

IVDR Class D reference laboratory

IVDR Class D devices require a reference laboratory opinion under Article 48(4) before the notified body issues the certificate.

Notified body scope check

The notified body's NANDO designation scope must cover the device type and the conformity assessment annex route used; otherwise the certificate is invalid.

GSPR checklist requirement

The MDR Annex I and IVDR Annex I GSPR checklist must address every applicable requirement and justify each non-applicability with a documented rationale.

Technical documentation retention

Technical documentation must be kept for at least 10 years after the last device is placed on the market, or 10 years after the last IVD is manufactured.

Declaration of Conformity content

The EU Declaration of Conformity must identify the regulation, device class, manufacturer, notified body certificate number, and be signed and dated.

Software documentation standard

MDCG 2019-16 requires software description, architecture, verification and validation evidence, and cybersecurity documentation in the technical documentation.

MDR Annex VIII classification

MDR Annex VIII contains 22 classification rules grouped by invasiveness, duration, and anatomy; Class I subdivides into Is, Im, and Ir.

IVDR Annex VIII classification

IVDR Annex VIII contains Rules 1-7 classifying IVDs into Class A, B, C, and D, with Rule 3 covering transmissible agents and Rule 4 blood grouping.

Class III expert panel

Under MDR Article 54, the notified body must review the clinical evaluation assessment report for Class III and implantable devices and may consult the expert panel.

Clinical evaluation report update

The CER must be updated throughout the device lifecycle using PMS and PMCF data, per MDR Annex XIV Part A and MDCG 2020-1.

Equivalence three pillars

Equivalence requires technical, biological, and clinical equivalence per MDR Annex XIV Section 3, with contractual access to the equivalence data.

IVDR performance evaluation

IVDR Article 56 requires performance evaluation covering scientific validity, analytical performance, and clinical performance per Annex XIII Part A.

Clinical investigation authorisation

Clinical investigations require an ethics committee opinion and competent authority authorisation in each Member State under MDR Articles 62-80 and Annex XV.

PSUR frequency

PSUR is required for Class IIa every 2 years, Class IIb and III annually, IVD B and C every 2 years, and IVD D annually.

Serious incident reporting deadline

Serious incidents must be reported within 15 days; serious public health threats within 2 days; device deficiencies that could lead to serious incidents within 10 days.

Trend reporting obligation

Under MDR Article 88, statistically significant increases in non-serious incidents or expected undesirable side-effects must be reported as a trend.

ISO 13485 status

ISO 13485:2016 is the harmonised QMS standard for medical devices; certification is not mandatory but is the practical route to MDR Annex IX QMS conformity.

ISO 14971 risk management

ISO 14971:2019 requires a risk management system covering hazard identification, risk estimation, evaluation, control, and residual risk evaluation throughout the lifecycle.

Critical supplier audit

Critical suppliers such as contract manufacturers and sterilisation providers must be audited on a risk-based frequency documented in the QMS.

Basic UDI-DI role

The Basic UDI-DI is the primary key for device grouping in EUDAMED and must be consistent across the technical documentation, DoC, and EUDAMED registration.

EUDAMED six modules

EUDAMED comprises actor registration, UDI/device registration, notified bodies and certificates, clinical investigations, vigilance, and market surveillance modules.

MDCG 2021-24 scope

MDCG 2021-24 provides classification guidance for medical devices under MDR Annex VIII, including decision trees and examples for each rule.