CRFWEB INFO SHEET

EU Medical Device Regulation (MDR)

26 May 2021, was the date of application (DoA) for the European Union’s Medical Device Regulation ((EU)2017/745) –“MDR”.

The introduction to the legislation states:

“(4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety.”

The changes and additions to existing regulation resulting from MDR will also impact on:

Device Classification
Quality Management Systems and Technical Documentation
Product Liability
Supply Chain Regulation
Product Labelling

Devices already on the market under the Directives 90/385/EEC and 93/42/EEC – and those expected to have completed the compliance process before 26 May 2021 can continue to be made available (or enter the market) until May 26, 2024 providing:

The device has not expired (see EU MDR Article 94.3a)
There are no significant changes (as determined by the notified body and competent authorities)

Overview

In spite of the detailed requirements set out in the MDR, manufacturers with experience in conducting clinical investigations will certainly be familiar with many of the requirements. MDR, like the MDD, relies upon processes, methodologies and procedures based on the European harmonized standard, BS EN ISO 14155:2011, which has now been updated as BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice.

Where to start?

Device Classification is of course the place to start – from that decision will flow all subsequent requirements and related activities. There are substantive changes in comparison to current Directives and so you will need to closely read MDR Annexe VIII – Classification Rules. It is notable that most software is likely to fall under the Class IIa and a smaller number may also be Class IIb or Class III (see rule 11).

It is important to have a clear grasp of the general requirements set out in:

Annexe I – General Safety & Performance Requirements (GSPR)

Annex II – Documentation

Annex III – Documentation on post-market surveillance

Clinical Evaluation and Clinical Investigations requirements under MDR

Manufacture requirements for Clinical Evaluation and Clinical Investigations are set-out in Chapter VI. The requirements regarding clinical investigations are far more detailed and precise in comparison with those to be found in current Directives.

Chapter VI, articles 62 through to 80 address:

General requirements regarding clinical investigations conducted to demonstrate conformity of devices
Informed consent
Clinical investigations on subjects requiring special consideration – minors, breastfeeding women, emergency situations
Member state processes for applications, assessment and corrective measures
The conduct of a clinical investigation and investigation information requirements
Electronic system for clinical investigations

The key appendices for Clinical Evaluation and Clinical Investigation are:

Annexe XIV: Clinical Evaluation and Post Market Clinical Follow-Up

Annex XV: Clinical Investigations

Chapter 1: General Requirements

Chapter 2, Documentation Regarding the Application for Clinical Investigation

Chapter 3, Other Obligations of the Sponsor

EU Guidance for CI, CE and PMCF under MDR

As already indicated, the importance placed on clinical evaluation, vigilance and market surveillance has significantly expanded compared to the MDD. The Medical Device Consultation Group (MDCG) has now published extensive guides to help manufacturers which are increasingly replacing or supplementing existing MEDDEV guidance.

Key guidance documents accessed from the link above include:

MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

MDCG 2020-5 Guidance on clinical evaluation – Equivalence

MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices

MDCG 2020-7 Guidance on PMCF plan template

MDCG 2020-8 Guidance on PMCF evaluation report template

MDCG 2019-9 Summary of safety and clinical performance

MDCG 2020-10/1 Appendix: Clinical investigation summary safety report form

MDCG 2020-10/2 Guidance on safety reporting in clinical investigations

MDCG 2020-13 Clinical evaluation assessment report template

The following, older, guidance is still pertinent for CI under MDR:

MEDDEV 2.7/4 on the need for, and general principles of, clinical investigations

MEDDEV 2.7/2 Rev 2 on clinical investigation validation and assessment by competent authorities

MEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting

Further guidance concerning the role of EUDAMED and guidance concerning IVDR may also be found HERE

Post Market Surveillance and Vigilance

Chapter VII Sections 1 & 2 of MDR sets out manufacturer obligations for both Post Market Surveillance and Vigilance.

Key changes to Vigilance Guidance under MDR

Guidance document MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to be the primary guidance document for vigilance reporting under MDR (and IVDR). However, for both MDR and IVDR, the reporting window for serious incidents that did not lead to death or serious deterioration in health has been cut from 30 to 15 days.

See Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8.

This guidance contains updated Manufacturer’s Incident Report (MIR) form – MIR form V7.2. This form became mandatory in January 2020. This form is universally applicable for all Incident/Serious Incident reporting under existing AIMDD, MDD, and IVD Directives as well as the new MDR and IVDR Regulations.

Important: Since the new EU MDR will become mandatory for all post-market activities beginning May 26, 2021, medical device manufacturers will need to ensure that their procedures are updated and employees responsible for vigilance reporting are trained on the change in reporting timeline.

How can we help you?

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Data management, analysis and reporting

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