May 2020 – MDR is less than 3 months away – Are you ready?
We would like to help you with the latest updates from the EU market and make sure you are in line with the upcoming regulations.
Commission News – The Delays
It appears that the commission is not fully ready yet and the EUDAMED database is not ready. The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices, May 2022.
The number of Notified Bodies accredited for the MDR is still very low – only 9 Notified Bodies have been approved as of February 5th, 2020, according to the Commission’s “rolling plan”. About 20 designations are expected to be completed in the course of Q1 2020.
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.
Recently, few guidance have been updated:
MDCG 2019-14 (December 2019)- Explanatory note on MDR codes. These codes are primarily used by designating authorities to define the notified body scope of designation
MDCG 2019-13 (December 2019)- This guidance is intended to define the requirements of sampling for Class IIa and Class IIb devices under the MDR and Class B and Class C devices under the IVDR for the purpose of assessing the technical documentation.
MDCG 2019-11 (October 2019)- This document, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the new medical devices regulations and provides guidance on the application of classification criteria for software under Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.2
MDCG 2019-16 (December 2019)- The primary purpose of this document is to provide manufacturers with guidance on how to fulfill all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cyber security.
MDCG 2019-15 (December 2019)- The purpose of this document is to provide guidance to manufacturers of Class I medical devices (other than custom made devices) who place on the Union market medical devices (from now on referred to a devices) under their name or trademark, to help them meet the provisions of the MDR.
ISO 14971:2019 – The new edition of the medical device risk management standard. The overall process remains unchanged, but the 2019 revision clarifies & elaborates on benefit-risk when evaluating the amount of risk involved with devices. This standard introduces three new definitions – 1) Benefit 2) Reasonably Foreseeable Misuse and 3) State-of-the-Art. The new version is aligning the terms that are being used by the new EU MDR. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel. This makes TR 24971, an essential document together with the ISO 14971 implementation.
UDI Technical Documentation – on December 2019 the European Commission published 8 new documents related to the technical specifications for unique device identifiers (UDIs). The new system will be applied to all medical devices except custom-made and performance study/investigational devices
2nd MDR Corrigendum – Class I that now requires an involvement of a notified body – The European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), giving manufacturers of certain Class I devices an additional four years to comply with the regulations. The corrigendum, published on 25 November 2019,changes Article 120(3) by inserting additions: “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that from 26 May 2020 it continues…”