Medical device CE marking

2024-04

The European Commission published the final report on the Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market.

The study started in December 2022 and was performed over 14 months.  The study main objective was to evaluate how the provisions established in the MDR have been implemented in European countries and how such provisions operate.

In the context of the study, a dashboard has been developed. The dashboard (click on the arrows at the bottom of the dashboard to scroll through the different pages) presents an overview of the mapping activities within the study regarding the reprocessing and reuse of single-use-devices in the EU.

The final report can be downloaded in our library

Source: European Commission

2024-03

This guidance document is not legally binding. It has been developed following contribution from national competent authorities, industry and relevant stakeholders and it should therefore be recognised as best practice. It has been written to support sponsors developing their CIP by describing in greater detail what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. Moreover, a CIP with the appropriate content will be instrumental in the conduct of the clinical investigation.

The document and appendix can be downloaded in our library

Source: European Commission

2024-02

Guiding principles have been developed for use by the IMDRF to advance health equity discussions for underrepresented populations in the development, evaluation and regulation of medical devices. This document is intended to assist IMDRF working groups in considering health equity principles, where relevant, in the development of IMDRF technical documents. These principles should be considered throughout the total product lifecycle.

Each working group will determine how best to use this document in their discussions and deliverables.

The document can be downloaded in our library

Source: IMDRF

2024-01

In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety.

Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices. Today, we are proposing to take additional steps:

• to ensure the availability of in vitro diagnostics by allowing more time for manufacturers to transition to the new rules, subject to certain important conditions.
• to enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED
• to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro

The documents can be downloaded in our library: Commission proposal, Press release, Q&A and Factsheet

The Proposal will now be put forward to the European Parliament and Council for adoption.

Source: European Commission

2023-12

This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of
equivalence, for implantable and class III medical devices to be placed on the European market. It also provides examples and considerations relevant to the demonstration of “sufficient levels of access to the data” per Annex XIV Section 3.

The document can be downloaded in our library

Source: European Commission

2023-12

On December 19, 2023, the European Commission published revision 1 of the MDCG 2021-27: on “Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.

This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices.

The revision 1 can be downloaded in our library

Source: European Commission

 

2023-12

MDCG 2019-07, on the Person Responsible for Regulatory Compliance (PRRC, Article 15 of the MDR/IVDR), was originally published in June 2019 and has now been revised.

There are updates on:

• Qualifications needed to hold the role of the PRRC
• PRRC requirements for Micro and Small Manufacturers
• Roles and responsibilities of the PRRC of a manufacturer (Article 15(3))
• Entities assuming the obligations of a manufacturer
• Registration of the PRRC in EUDAMED

The guidance can be downloaded in our library

Source: European Commission

2023-12

On December 14 2 new guidances were published by the MDCG:

– MDCG 2023-5: Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
Products without an intended medical purpose that are listed in the Annex XVI to MDR and that are included in the scope sections of the CS’ annexes are covered also by the MDR. Qualification of a product without an intended medial purpose precedes its classification. Only products that qualify as devices and that are covered by the CS and the MDR should then be classified according to the rules set out in Annex VIII to MDR and in Commission Implementing
Regulation (EU) 2022/2347 on reclassification. Classification rules set out in Annex VIII to MDR apply to those products. Also Commission Implementing Regulation (EU) 2022/2347 applies for classification purposes of certain active devices without an intended medical purpose.

– MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies.
According to Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices5, hereinafter referred to as CS, in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose where all available results of clinical investigations relate to medical devices only. Therefore, clinical investigations should be performed for products without an intended medical
purpose.

Both guidances can be downloaded in our library (see above links)

Source: European Commission

2023-12

On December 12, the MDCG published Revision 1 of guidance 2021-6: Regulation (EU) 2017/745 ̶ Questions & Answers regarding clinical investigations, a document that answers many outstanding questions relating to clinical investigations.

The guidance deals with the fundamental issue of what the general differences and improvements related to clinical investigations are under the MDR as compared with the medical device directives and is broken into sections dealing with the following topics: general questions; modifications; timeline considerations; clinical investigation reports; and arrangements for the transitional period.

The document can be downloaded in our library.

Source: European Commission.

2023-12

On December 6 Regulation 2023/2713 was published in the Official Journal.

When an EU reference laboratory is designated, according to Regulation (EU) 2017/746, class D devices have to undergo a performance verification and batch testing by the EU reference laboratory. To ensure sufficient availability of EU reference laboratory services, the selection board also took into account the collective capacity of the candidate laboratories for performance verification and batch testing.

The document can be downloaded in our library

Source: EUR-Lex