Medische hulpmiddelen update: maart 2024

Rechtspraak

Hoven

Hof Arnhem-Leeuwarden 26 maart 2024, ECLI:NL:GHARL:2024:2122 (Appellant tegen Zilveren Kruis)
Zorgverzekeringsovereenkomst. Vergoeding heupoperatie MoM-HRA niet in Nederland vergoed. Stand van wetenschap en praktijk.

Europese Unie

Harmonised standards
Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the basis of a Standardisation Request issued by the Commission according to Regulation (EU) No 1025/2012.

Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover.

The Commission issued a standardisation request to CEN and CENELEC on 14 April 2021. It is available in the “eNorm Platform - European Commission standardisation requests” as M/575 (EN version - FR and DE available, clicking on the linguistic icon).

An amendment to the standardisation request was adopted on 31 January 2023: it is also available as M/575 Amd 1 in the EN, FR and DE versions.

The publications in the OJEU of references of harmonised standards under the medical devices regulations are available:

For Regulation (EU) 2017/745 on medical devices:

• Commission Implementing Decision (EU) 2024/815 of 6 March 2024
• Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 
• Commission Implementing Decision (EU) 2022/757 of 11 May 2022  
• Commission Implementing Decision (EU) 2022/6 of 4 January 2022
• Commission Implementing Decision (EU) 2021/1182 of 16 July 2021

For Regulation (EU) 2017/746 on in vitro diagnostic medical devices:

• Commission Implementing Decision (EU) 2024/817 of 6 March 2024
• Commission Implementing Decision (EU) 2023/1411 of 4 July 2023  
• Commission Implementing Decision (EU) 2022/729 of 11 May 2022  
• Commission Implementing Decision (EU) 2022/15 of 6 January 2022
• Commission Implementing Decision (EU) 2021/1195 of 19 July 2021

Summary / consolidated lists of the above publications are available on the standardisation webpages on healthcare engineering: Medical devices, In vitro diagnostic medical devices.

European Commission, March 2024

Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices - MDCG 2024-3
This guidance document uses section 3 of chapter II in Annex XV of the MDR as a starting point, and follows the numbering of the regulation, in order to facilitate cross referencing to the legal requirements. It is not intended to be a template for writing a CIP, and it is not mandatory to present the information in a CIP in the same order as they are mentioned in the MDR or in this guidance.

In combined studies of medical devices and pharmaceutical products, there is an obvious need to accommodate the legal requirements from several regulations, and thus the structure and content of the CIP may need to be adapted. However, sponsors need to be aware that the elements required by MDR need to be present in a combined CIP/study protocol, and this guidance is intended to be useful also in those situations.

European Commission, March 2024

Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) - July 2022 – June 2023
According to Article 54(4) of the MDR, the Commission is obliged to draw up an annual overview of devices which have been subject to the CECP, including:

• for all devices in scope of the CECP, a listing of notifications by NBs on whether or not the CECP applies;
• for all devices not exempted from the CECP, a listing of those for which the expert panels decided to provide an opinion;
• for all devices subject to an opinion from the expert panels, a listing of the cases where the NB did not follow the advice from the expert panel.

The second annual overview covers the activities of the expert panels from 1 July 2022 until 30 June 2023.

In the reporting period, 353 notifications under Article 54(3) of the MDR were sent by 13 NBs. Listings of these notifications are reported in Annex 1 (devices for which CECP applies) and Annex 2 (devices exempted from the CECP).

European Commission, 25 March 2024

Overview of language requirements for manufacturers of medical devices; updated
The Commission and Member States have created MDR and IVDR tables.

These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requirements for each Member State.

The last column of the tables includes the language requirements about the graphic user interface (GUI) (e.g., apps). There is no specific article foreseen in MDR/IVDR, but some countries have their own national legislation and rules about GUIs.

• MDR - language requirements for manufacturers Rev. 1
• IVDR – national language requirements for manufacturers Rev. 1

European Commission, 22 March 2024

Notified Bodies Survey on certifications and applications (MDR/IVDR) (revised version)
Survey results of the 6th NB survey with data status 31 October 2023 (small, medium and large dataset)

European Commission, 11 March 2024

CBG

Medical devices - checklist
Aangezien medische hulpmiddelen een substantie kunnen bevatten die een geïntegreerd onderdeel vormt van het medisch hulpmiddel, maar bij separaat gebruik een geneesmiddel zou zijn, heeft het CBG een checklist opgesteld over de consultatieprocedure die bij de beoordeling van dergelijke medische hulpmiddelen van belang is. Deze checklist beschrijft alle eisen waar een dossier over een medisch hulpmiddel aan moet voldoen voor een consultatie- of herconsultatieprocedure.

CBG, 20 maart 2024