Simpler and more effective rules for medical devices – Commission proposal for a targeted revision of the medical devices regulations
On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective and further promote competitiveness, innovation and a high-level of patient safety in this key sector. The proposal will simplify EU rules for medical devices, support the digitalisation of procedures, and offer a modern, adaptive framework so that companies can respond to changing market conditions and patient needs:
The adoption of the Legislative proposal was announced in a press release.
The key elements of the revision are summarised in a factsheet, and in a questions and answers document.
Two staff working documents support the proposal:
The proposal has been submitted to the European Parliament and the Council. To become binding Union law, the co-legislators need to adopt the text by ordinary legislative procedure. An overview of this procedure is available in the European Parliament website. You can follow the development of the legislative decision-making process on the "Legislative Observatory" of the European Parliament.
Medical Devices regulations
The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation.
Two new regulations on medical devices and in vitro diagnostic medical devices entered into force in May 2017.
Read the press release from the European Commission.
With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
With effect from 26 May 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices replaced Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.
Regulation 2017/745 and Regulation 2017/746 provide for transition periods during which devices that are in conformity with the previous Directives can still be placed on the EU market.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
Extension of the transition periods laid down in the regulations
- Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the information obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices.
- Press statement on the adoption of the co-legislators
- Commission proposal and press release and Q&A
- Factsheet
- Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860
- Q&A Extension of the IVDR transitional periods
- Template for a manufacturer's declaration available on the website of MedTech Europe
- Template for notified body confirmation letter endorsed by NBCG-Med
- Q&A Gradual roll-out of Eudamed
- Q&A Obligation to inform in case of interruption or discontinuation of supply
- Q&A Extension of the IVDR transitional periods
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions.
It also deletes in both MDR and IVDR the "sell-off" deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.
- Press statement on the adoption by co-legislators
- Commission proposal and press release and Q&A
- Factsheet
- Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
- Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period
- Template for notified body confirmation letter endorsed by NBCG-Med
- Template for a manufacturer's declaration available on the websites of the EU level industry associations: AESGP, COCIR, EuromContact, EUROM VI and MedTech Europe
- Updated factsheets
Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and deferred the application of conditions for in-house devices.
While the IVDR has been applicable since 26 May 2022, the amendment allows for its progressive rollout, enabling a stepwise transition to the Regulation. This includes in vitro diagnostic medical devices already covered by a certificate or a declaration of conformity issued in accordance with the previous IVD Directive 98/79/EC.
- Press statement on the adoption by the co-legislators
- Commission proposal
- Press release and Q&A
- Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions postponed the entry into application of Regulation (EU) 2017/745 (MDR) by one year until 26 May 2021.
Implementing measures for regulations
2025
2024
2023
- Implementing Regulation 2023/2713 – designation of EU reference laboratories for in vitro diagnostic medical devices
- Implementing Regulation 2023/1194 – transitional provisions for products without intended medical purpose
2022
- Implementing Regulation 2022/944 – EU reference laboratories for in vitro diagnostic medical devices
- Implementing Regulation 2022/945 – fees levied by EU reference laboratories for in vitro diagnostic medical devices
- Implementing Regulation 2022/2347 – reclassification of active products without intended medical purpose
- Implementing Regulation 2022/2346 – common specifications for products without intended medical purpose
- Implementing Regulation 2022/1107 – common specifications for certain class D in vitro diagnostic medical devices
2021
- Implementing Regulation 2021/2226 – electronic instructions for medical devices
- Implementing Regulation 2021/2078 – European Database on Medical Devices (Eudamed)
2020
2019
- Implementing Decision 2019/1396 – medical-devices expert-panel designation
- Implementing Decision 2019/939 – entities designated to issue UDIs for medical devices
2017
Delegated acts adopted under the regulations
2025
2023
- Delegated Regulation 2023/2197 – UDI assignment for contact lenses and application-date amendment
- Delegated Regulation 2023/502 – frequency of complete re-assessments of notified bodies (C/2022/8640)
- Delegated Regulation 2023/503 – frequency of complete re-assessments of notified bodies (C/2022/8649)
2022
Other acts
Corrigenda to the regulations
2019
- Corrigendum to Regulation 2017/745 – medical devices (December 2019)
- Corrigendum to Regulation 2017/746 – in vitro diagnostic medical devices (December 2019)
- Corrigendum to Regulation 2017/745 – medical devices (May 2019)
- Corrigendum to Regulation 2017/746 – in vitro diagnostic (May 2019)
Factsheets
Dedicated factsheets provide a summarised view of the main areas of activities in the medical devices sector.
Guidance
Guidance documents aiming at an effective and harmonised implementation of the legislation are available.
They present a common understanding of how the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices should be applied in practice.
The majority of these documents are drafted in collaboration with interested parties represented in the various concerned working groups and are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR
The on-going guidance development document summarises the on-going guidance documents and deliverables of MDCG subgroups.
For Regulation (EU) 2017/746 on in vitro diagnostic medical devices, a joint implementation plan was endorsed in principle by the Medical Device Coordination Group (MDCG).
Input from stakeholders was taken into account. The plan outlines the essential and high-priority actions that are to be completed before the date of application of IVDR, across relevant MDCG sub-groups.
In addition to setting priorities, the joint implementation plan serves to monitor progress. The status and timelines of each action are regularly reviewed in MDCG meetings and updated to reflect the progress with each work item.
