MDCG Pre-Registration Assessment cheat sheet

MDR 2017/745 applies to medical devices and accessories; IVDR 2017/746 applies to in vitro diagnostic medical devices. Both Regulations are directly applicable in all EU Member States without national transposition.

MDR Article 10 and IVDR Article 10 place obligations on manufacturers: risk management, clinical/performance evaluation, technical documentation, conformity assessment, UDI assignment, and post-market surveillance.

Transitional provisions: MDR applies from 26 May 2021, IVDR from 26 May 2022. Legacy certificates under MDD 93/42/EEC and AIMDD 90/385/EEC were extended by Regulation (EU) 2023/607 under conditions tied to application lodgement and notified body agreements.

MDCG guidance documents are not legislation; they represent the views of the Medical Device Coordination Group and are persuasive but non-binding. Notified bodies and competent authorities use them as assessment benchmarks.

MDCG guidance is structured by topic: classification, conformity assessment, clinical evaluation, PMS/vigilance, UDI/EUDAMED, and IVD-specific documents. Document numbers (e.g., MDCG 2021-24) are the citation key.

Economic operators are manufacturer, authorised representative, importer, and distributor. Each has distinct verification duties under MDR Articles 11-14 and IVDR Articles 11-14.

A manufacturer established outside the EU must appoint an authorised representative before placing a device on the Union market; the mandate must cover regulatory liaison and incident reporting support.

The MDR/IVDR do not cover medicinal products, human tissues/cells of non-device origin, or cosmetic products; borderline products follow MDCG 2022-5 (MDR) and MDCG 2022-6 (borderline IVDs).

MDR classification uses Annex VIII: 22 rules grouped by invasiveness, duration, and anatomy. Class I, IIa, IIb, III; Class I subdivides into Is (sterile), Im (measuring), and Ir (reusable surgical instruments).

Duration definitions: transient <60 minutes; short-term 60 minutes to 30 days; long-term >30 days. Duration and invasiveness together drive the class.

Rule 11 (software) classifies software intended to provide information for diagnostic or therapeutic decisions as Class IIa; if the decision may cause death or irreversible deterioration, Class IIb; if death or irreversible deterioration is likely, Class III.

Rule 10 (active therapeutic devices) and Rule 9 (active therapeutic devices administering or exchanging energy) are the primary active-device rules; Rule 9 typically yields Class IIa/IIb depending on hazardous energy.

IVDR classification uses Annex VIII (IVDR) with Rules 1-7: Class A (lowest), B, C, D (highest). Rule 3 covers transmissible agents; Rule 4 covers blood grouping; Rule 5 covers IVDs for cancer, genetic testing, or monitoring of medicinal products.

Class A IVDs that are not sterile and have no measuring function are self-certified (no notified body). Class A sterile devices require notified body involvement for the sterility aspect only.

Classification is the manufacturer's responsibility but is verified by the notified body during conformity assessment; misclassification is a common cause of non-conformity findings.

MDCG 2021-24 provides classification guidance for MDR; MDCG 2020-16 provides IVDR classification guidance. Both include decision trees and examples.

Class I non-sterile, non-measuring devices: manufacturer self-certifies and issues the EU Declaration of Conformity; no notified body required under MDR Annex II and IV.

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

Class IIb: Annex IX (QMS + technical documentation assessment) or Annex XI Part A (production quality assurance) plus Annex IX Section 4; for implantable Class IIb, Annex X (type-examination) may be combined.

Class III: Annex IX (QMS + technical documentation assessment) or Annex X (type-examination) plus Annex XI Part B (product quality assurance). Annex IX requires assessment of each technical documentation.

IVDR Class A (non-sterile, no measuring function): self-certification. Class A sterile, Class B, C, D require notified body involvement; Class D requires reference laboratory testing under IVDR Article 48(4).

Notified body designation is under MDR Article 42 / IVDR Article 38; NANDO database lists designated bodies and their scopes. Scope must cover the device type and annex route used.

A notified body assessment includes QMS audit, technical documentation review, and where applicable, unannounced audits and product testing. The certificate states the annex route and device scope.

The manufacturer must lodge an application with a notified body before the certificate expiry under Regulation (EU) 2023/607; written agreement must be signed by 26 September 2024 for the extension to apply.

MDR Annex II and IVDR Annex II define technical documentation content: device description, labelling, design and manufacturing information, GSPR checklist, benefit-risk analysis, product verification and validation, and clinical/performance evaluation.

The GSPR checklist (MDR Annex I / IVDR Annex I) must address every applicable requirement and justify any non-applicability with a rationale.

Technical documentation must be kept for at least 10 years after the last device is placed on the market (MDR Article 10(8)); IVDs also 10 years, or 10 years after the last IVD manufactured.

Post-market surveillance plan, PSUR (Class IIa/IIb/III and IVD B/C/D), and PMCF plan are part of the technical documentation under MDR Annex III and IVDR Annex III.

The technical documentation must demonstrate conformity with the GSPRs, including risk management per ISO 14971 and, where applicable, IEC 62304, IEC 62366, and IEC 60601 series.

The Declaration of Conformity (MDR Annex IV / IVDR Annex IV) must be kept up to date and reference the applicable regulation, class, and notified body certificate number.

Technical documentation must be provided to the notified body and, on request, to competent authorities; it must be available in an official EU language as required by the Member State.

For devices incorporating software, the documentation must include software description, architecture, verification and validation evidence, and cybersecurity documentation per MDCG 2019-16.

MDR Annex I: General Safety and Performance Requirements (GSPRs), 23 chapters. IVDR Annex I: GSPRs for IVDs, 20 chapters.

MDR Annex II: technical documentation; Annex III: technical documentation on post-market surveillance; Annex IV: EU Declaration of Conformity; Annex V: CE marking; Annex VI: UDI; Annex VII: notified bodies; Annex VIII: classification; Annex IX-XI: conformity assessment; Annex XII-XV: certificates and miscellaneous.

IVDR Annex II: technical documentation; Annex III: PMS technical documentation; Annex IV: EU Declaration of Conformity; Annex V: CE marking; Annex VI: UDI; Annex VII: notified bodies; Annex VIII: classification; Annex IX-XI: conformity assessment.

Pre-registration submission typically requires: device description, classification rationale, GSPR checklist, risk management file, clinical evaluation report, PMS plan, and UDI-DI assignment.

The notified body application form must specify the annex route, device scope, and manufacturing sites; incomplete applications are rejected at the completeness check.

The EU Declaration of Conformity must be signed and dated; a draft DoC is not acceptable for certificate issuance.

For Class III and implantable devices, the notified body must review the clinical evaluation assessment report (CEAR) and may consult the expert panel under MDR Article 54.

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

MDR Article 61 requires clinical evaluation for all devices; clinical investigation is required where clinical evidence is insufficient, except for certain well-established technologies.

Clinical evaluation follows MDR Annex XIV Part A: identify clinical evidence, appraise it, and generate new evidence if needed. The clinical evaluation report (CER) must be updated throughout the lifecycle.

Clinical investigation is governed by MDR Articles 62-80 and Annex XV; it requires an ethics committee opinion and competent authority authorisation in each Member State.

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

IVDR performance studies are governed by Articles 57-77 and Annex XIII Part B; they require ethics committee and competent authority approval.

PMCF (MDR Annex XIV Part B) and PMPF (IVDR Annex XIII Part B) are required for Class IIa and above (and IVD B and above) unless justified as not applicable.

The clinical evaluation must be based on a systematic literature search with documented methodology, inclusion/exclusion criteria, and appraisal per MDCG 2020-1 and MDCG 2020-6.

Equivalence claims require demonstration of technical, biological, and clinical equivalence per MDR Annex XIV Section 3; the equivalence data must be contractually accessible.

MDR Article 83-86 and IVDR Article 78-81 require a PMS system proportionate to the device risk class; the PMS plan is part of the technical documentation.

PSUR (Periodic Safety Update Report) is required for Class IIa, IIb, III, and IVD B, C, D; frequency: Class IIa every 2 years, Class IIb/III annually, IVD B/C every 2 years, IVD D annually.

Serious incident reporting under MDR Article 87: 15 days for serious incidents, 2 days for serious public health threats, and 10 days for device deficiencies that could lead to serious incidents.

Field Safety Corrective Action (FSCA) must be reported and a Field Safety Notice (FSN) issued; the FSN must be reviewed by the competent authority where required.

Trend reporting (MDR Article 88) applies to statistically significant increases in non-serious incidents or expected undesirable side-effects; the manufacturer must report the trend.

Vigilance reporting uses the Manufacturer's Incident Report (MIR) form and EUDAMED; until EUDAMED is fully functional, national reporting channels apply per MDCG 2021-1.

PMCF must be part of the PMS plan; PMCF results feed back into the clinical evaluation and risk management file.

The PMS system must be audited by the notified body; the PSUR and PMS plan are reviewed during surveillance audits.

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

ISO 14971:2019 is the risk management standard; MDR Annex I GSPR 1-3 require a risk management system throughout the device lifecycle.

Supplier controls require: supplier evaluation and selection, documented purchasing information, verification of purchased product, and a supplier monitoring programme.

Critical suppliers (e.g., contract manufacturers, sterilisation providers) must be audited; the audit frequency is risk-based and documented in the QMS.

Outsourced processes remain the manufacturer's responsibility; a written quality agreement is required with critical suppliers.

The QMS must cover design controls, document control, record control, CAPA, non-conforming product, and complaint handling.

ISO 13485 certification is verified by the notified body during the QMS audit; the certificate scope must cover the device types and manufacturing sites.

Risk management must be integrated with the QMS; the risk management file must be maintained and updated with PMS data.

MDR Article 27 and IVDR Article 24 require UDI assignment; the UDI consists of a UDI-DI (device identifier) and UDI-PI (production identifier).

UDI must be placed on the label and, for reusable devices, on the device itself; Class III implantable devices require direct marking.

UDI-DI must be registered in EUDAMED before placing the device on the market; the Basic UDI-DI is the primary key for device grouping.

EUDAMED has six modules: actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, and market surveillance.

EUDAMED actor registration is mandatory for manufacturers, authorised representatives, importers, and distributors before they can register devices.

Data governance: the manufacturer is responsible for the accuracy of EUDAMED data; changes must be updated within the required timelines.

UDI issuing entities are designated by the European Commission; GS1, HIBCC, ICCBBA, and IFA are the designated entities.

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

MDCG 2021-24: classification of medical devices under MDR; includes decision trees and examples for each rule.

MDCG 2020-1: clinical evaluation of medical devices; MDCG 2020-6: clinical evidence for legacy devices; MDCG 2020-5: equivalence; MDCG 2020-7: PMCF plan; MDCG 2020-8: PMCF evaluation report.

MDCG 2019-16: cybersecurity for medical devices; MDCG 2019-11: qualification and classification of software; MDCG 2022-14: transition to MDR.

MDCG 2021-1: vigilance reporting; MDCG 2022-5: borderline products; MDCG 2022-6: borderline IVDs; MDCG 2021-5: clinical investigation of devices.

MDCG 2022-21: performance evaluation of IVDs; MDCG 2022-9: performance study applications; MDCG 2023-3: IVDR classification questions.

MDCG guidance is not legally binding but is used by notified bodies and competent authorities as the assessment benchmark; deviation must be justified.

Guidance documents are published on the European Commission's MDCG page; the document number and revision date must be cited in the technical documentation.

MDCG position papers (e.g., MDCG 2022-14 on transition) clarify interpretation but do not create new legal obligations.