Mandatory use of four EUDAMED modules for medical devices will begin on 28 May 20261. The transition periods for these modules, where applicable, are as follows: Actor Registration: requirements apply to manufacturers, Authorised Representatives, importers, and system and procedure…
On 23 April 2026, an update was made to the manufacturer incident report (MIR) form (version 7.3.1)1. Use of this updated form becomes mandatory on 1 May 2026 for reporting serious incidents under Regulation (EU) 2017/745 on medical devices and…
In April 2026, the first revision of Medical Device Coordination group guidance MDCG 2021-24 Rev.1, Guidance on classification of medical devices, was released1. The changes made in this latest version affected the following sections: 1 General requirements (updated); 1.4…
MDCG 2025-8 Rev. 1, Guidance on the implementation of the Master UDI-DI [Unique Device Identification-Device Identifier] solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was released by the Medical Device Coordination Group in March 20261. The changes introduced…
Commission Implementing Decision (EU) 2026/193 of 28 January 20261 amends the Annex to Implementing Decision (EU) 2021/1182, which lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745 (MDR). Commission Implementing Decision (EU) 2026/193 adds the following…
On 20 March 2026, the European Commission adopted two Delegated Regulations1 that will expand the list of well-established technologies referred to in Regulation (EU) 2017/745 on medical devices (MDR), with a view to exempting them from some legal requirements and…
The European Commission has updated its question-and-answer style guidance1 on the obligations to inform in case of interruption or discontinuation of supply of certain devices. It has also published a decision tree2 to help manufacturers of medical devices assess the…
Introduction The European Union (EU) medical devices sector encompasses more than 38,000 companies, approximately 90% of which are small and medium sized enterprises (SMEs), and employs over 930,000 people across Europe1. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation…
Introduction The rapid growth of artificial intelligence (AI) within healthcare has challenged Europe’s regulatory infrastructure and amplified regulatory pressures. Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 have established rigorous…
The first revision of Medical Device Coordination Group MDCG 2025-7, MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was issued in December 2025. Revision 1 includes…
Commission Decision (EU) 2025/2371, which was published on 27 November 2025, confirms that the first four modules of the European Database on Medical Devices (EUDAMED) have achieved functionality and meet the required functional specifications1. To ensure legal certainty and a…
COM(2025) 1023 final (dated 16 December 2025)1 sets out proposed amendments to Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) that have been designed to simplify and reduce the burden of the…
At the Medical Device Coordination Group (MDCG) plenary meeting on 24 September 2025, the European Commission presented an updated status of the development of EUDAMED1. The new timetable means that mandatory use of the first four modules – Actor, UDI/Device,…
Commission Implementing Decision (EU) 2025/20781 amends the Annex to Implementing Decision (EU) 2021/1182 with respect to harmonised standards for surgical clothing and drapes, medical face masks and sterilisers for medical purposes. Implementing Decision (EU) 2021/1182 lists the references of harmonised…
The first revision of MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR, has been released1. This updated guidance, which primarily targets medical device software (MDSW) manufacturers, sets…
The European Commission has published a summary of the contributions made by stakeholders1 in the public consultation launched in the context of the targeted evaluation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro…
In June 2025, the Joint Artificial Intelligence Board AIB 2025-1 / Medical Device Coordination Group MDCG 2025-6 guidance document entitled Interplay between the Medical Devices Regulation (MDR) & In Vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act…
A pilot coordinated assessment of clinical investigations and performance studies has been launched1 across multiple Member States as per Article 78 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 74 of Regulation (EU) 2017/746 on in vitro diagnostics…
Commission Implementing Decision (EU) 2025/681 of 8 April 20251 amends the Annex to Implementing Decision (EU) 2021/1182, which lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745 (MDR). Commission Implementing Decision (EU) 2025/681 adds the following…
At its meeting on 20 November 2024, the Federal Council decided1 to modify the Ordinance on In Vitro Diagnostics (IVDV) to extend the transition periods for the new requirements for in vitro diagnostics (IVDs) in line with European Regulation (EU)…
A question-and-answer style document has been published1 on the practical aspects relating to the implementation of the obligations to inform about interruption or discontinuation of supply of certain devices laid down in Article 10a of Regulation (EU) 2017/745 on medical…
A question-and-answer document has been published1 on practical aspects relating to the implementation of the gradual roll-out of EUDAMED pursuant to Regulations (EU) 2017/745 and 2017/746, as amended by Regulation (EU) 2024/1860. Regulation (EU) 2024/1860 enables a gradual roll-out of…
MDCG 2024-15, Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED, was published by the Medical Device Coordination Group (MDCG) in November 20241. Article 77(5) of Regulation (EU) 2017/745 on medical devices…
A European Parliament Resolution (C/2025/485) on the urgent need to revise Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) was published in the Official Journal on 29 January 20251. In this Resolution,…
Interested parties have until 21 March 2025 to submit comments on a targeted evaluation1 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics, which has been designed to help the European Commission take stock…
The provisions of Regulation (EU) 2023/607 amending the transitional provisions of certain medical devices and in vitro diagnostic medical devices contained in Regulations (EU) 2017/745 and 2017/746 have been implemented in Turkey in line with the European Union Member States.…
The Spanish Agency for Medicines and Medical Devices (AEMPS) has just published the results of a survey1 it conducted of Spanish manufacturers of in vitro diagnostic products (IVDs), between 5 December 2023 and 31 January 2024, to evaluate their level of implementation…
The first revision1 of MDCG 2021-4 has been published to provide updated guidance on the application of the transitional provisions for the certification of Class D in vitro diagnostic medical devices (IVDs) according to Regulation (EU) 2017/746 (IVDR). According to…
Commission Implementing Regulation (EU) 2024/2699 of 18 October 20241 sets out detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the European Commission with the European Medicines Agency in the form of…
The first update of Medical Device Coordination Group (MDCG) guidance MDCG 2021-25 Rev. 1, Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with…
Commission Implementing Decision (EU) 2024/2631 of 8 October 20241 amends the Annex to Implementing Decision (EU) 2021/1182, which lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745 (MDR). Commission Implementing Decision (EU) 2024/2631 adds the following…
The Egyptian Drug Authority has published details of a mechanism for handling changes mentioned in the letters extending the deadline issued by a European Notified Body granting quality certificates where those changes are not documented in the medical device’s registration…
Interested parties have until 13 November 2024 to submit comments on the proposed alignment of Australia’s Essential Principles for Safety and Performance with the European Regulations1,2. In 2019, the Therapeutic Goods Administration (TGA) held its first consultation on proposed changes…
The first module of the swissdamed medical devices database for the registration of companies and economic operators (ACT module) will become active on 6 August 20241. Applications for the registration of, and changes to, the Swiss Single Registration Number (CHRN),…
The Norwegian Medical Products Agency recently held a public consultation1 on a proposal for the implementation into Norwegian law of Commission Implementing Regulation (EU) 2023/2713 on the designation of European Union reference laboratories for in vitro diagnostic medical devices. The…
A new Guide for Health Institutions that Manufacture and Use In-house In Vitro Diagnostic Medical Devices in Ireland (SUR-G0052-1) has been published by the Health Products Regulatory Authority (HPRA)1. This guide provides an overview of the legislation and key concepts…
From 1 September 2024, the procedure for anticipating and managing the unavailability of medical devices and in vitro diagnostic medical devices (IVDs) will be changing to enable anticipated and structured action by all stakeholders in managing the unavailability of certain…
Economic operators who are required to register in the medical device sector must register either in the public European EUDAMED database or in Finland’s national CERE register. The CERE register is a nationally maintained register of medical device economic operators…
MDCG 2022-13 Rev. 1, Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies, was published in June 20241. Revision 1 of the Medical Device Coordination Group (MDCG) document adds guidance on the conduct of joint assessments relating to…
In May 2024, the Medical Device Coordination Group (MDCG) issued the following templates for preliminary assessments/re-assessments of Notified Body documentation by Designating Authorities: MDCG 2024-6, Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745)1; MDCG 2024-7, Preliminary assessment review…
On 9 July 2024, Regulation (EU) 2024/1860 was published in the Official Journal1 to implement a gradual rollout of the EUDAMED database, introduce an obligation to inform in case of interruption or discontinuation of supply, and set new transitional provisions…
On 15 April 2024, the Medical Device Coordination Group (MDCG) released MDCG 2024-4, Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/7461. This document defines serious adverse event reporting modalities and includes a summary…
The first revision of Medical Device Coordination Group (MDCG) guidance MDCG 2022-9, Summary of Safety and Performance Template, was issued in April 20241. The guidance is divided into two main sections: Section 1 concerns the Summary of Safety and Performance…
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics (IVDs) were designed to ensure the availability of safe and effective devices, to protect patient safety and public health, while making the sector more competitive and…
The Federal Institute for Drugs and Medical Devices (BfArM) has clarified1 that it may exceptionally allow the placing on the market in Germany of medical devices that have not undergone a regular conformity assessment procedure for CE marking if this…
Decree-Law No. 29/2024 was published on 5 April 2024 in the Official Gazette, ensuring the implementation of Regulation (EU) 2017/745 on medical devices in the Portuguese legal system1. This Decree-Law establishes, among other things, a set of rules applicable to…
On 21 March 2024, the Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 entered into force, introducing provisions required for implementing Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in Northern Ireland1. These provisions include the…
On 25 April 2024, the European Parliament adopted1 key updates to the legislation on medical devices, including in vitro diagnostic medical devices (IVDs), which will help prevent shortages and ease the transition to greater transparency and access to information. These…
Overview The European database on medical devices (EUDAMED) is considered the digital backbone for the European Union’s (EU’s) regulatory framework for medical technologies – Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical…
Introduction The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) was 26 May 2022; this is when the Regulation came into force with transitional arrangements for different device classes. Before looking at the lessons learnt, it…
