IVDR

Subscribe to IVDR via RSS

On 8 September 2025, the European Commission published a call for evidence on “the targeted revision of the EU rules for medical devices and in vitro diagnostics”. This is part of the Commission’s on-going “targeted evaluation” of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry caused by the regulations.Continue Reading European Commission’s call for evidence on the revision of the MDR/IVDR

The UK government has published its response to the recent consultation on the UK Medical Devices Regulations. As highlighted throughout the process to date, the focus is on improving regulatory scrutiny and oversight of medical devices and IVDs in the UK. Changes are aimed at closer alignment with international best practice and to ensure that Great Britain has risk proportionate regulations. Changes are not intended to introduce the EU Medical Devices Regulations into UK law, although there are of course similarities, which has been welcomed by those responding to the consultation.

There were four key areas under consultation: (1) International reliance, (2) UKCA marking, (3) IVD devices, and (4) Assimilated EU law. We have set out a summary on each of these below.Continue Reading UK Medical Devices Regulations: further changes afoot

The revised MDCG 2019-11 guidance on qualification and classification of software (the Revised Guidance)  introduces a series of clarifications and expansions that impact how software is qualified and classified as a medical device under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While the core principles remain unchanged, the Revised Guidance provides more detailed examples, specifically includes software using artificial intelligence (AI), and addresses modular software and interoperability with electronic health records (EHRs) under the European Health Data Space (EHDS).

This blog post outlines these key updates and considers their potential impact on compliance obligations for software manufacturers.Continue Reading Revised guidance on classification of Medical Device Software in the EU

On 13 June 2025, the European Commission launched the first phase of a pilot project under its COMBINE programme (the pilot project), aiming to streamline the authorisation process for combined studies involving both clinical trials of medicinal products and performance studies of in vitro diagnostic medical devices (IVD) (referred to as combined studies below).

The pilot project represents a significant step towards addressing the complex and fragmented regulatory landscape that sponsors currently face when submitting applications for combined studies across multiple EU countries. Although its practical effectiveness remains to be seen, the pilot project represents a positive development that should facilitate the approval of combined studies in the EU.

The pilot project is the first initiative under the COMBINE programme, with additional projects planned to launch in the coming years.Continue Reading European Commission launches COMBINE pilot to streamline approval of studies involving medicinal products and in vitro diagnostic medical devices

 In our blog in December 2024, we provided an update on the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs). We noted that two cases had been filed challenging the…

We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.

We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the beginning, as both the industry and the EU institutions, national authorities, and notified bodies have found it difficult to adapt to the stricter and demanding new legal requirements. There are ongoing delays in companies obtaining CE marks under the new regime, criticism that the rules are stifling innovation, and concerns about the impact on patients.

Given the calls for change, criticism, and ongoing consultations, this Advisory sets out the current status of developments and what is important to know when seeking to do business in the EU.Continue Reading EU Medical Devices Legislation: What You Need To Know Given Latest Developments and Ongoing Challenges

On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European Commission, the pilot allows sponsors to submit a single CI or PS application for review across multiple Member States, rather than each Member State conducting independent standalone reviews. The pilot scheme aims to make the application process for multi-national CI and PS more efficient and to reduce the duplication of activities by both the sponsor and competent authorities. As this has been a major cause of delays and complications in conducting CIs, this pilot will be welcomed by industry.Continue Reading EU announces pilot coordinated assessment for clinical investigations of medical devices

Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union.

Of note, health authorities in the EU continue to develop methods to assess and recommend health apps. The latest is in Denmark, where new guidance has been published on how health apps will be assessed by the Board for Health Apps. The assessment criteria includes evidence of clinical effectiveness, usability, price, and value to society. This guidance is another important step to ensure greater access to health apps across the EU.

It has been a busy year in digital health and the impact to care delivery is only just beginning. We hope you will continue to follow the digest in 2025 as we track what we expect to be an even busier year.   

Wishing you the best for the new year! 
The Arnold & Porter Team Continue Reading Virtual and Digital Health Digest – December 2024

The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable.

The Commission aims to assess the performance of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). Anyone interested in giving feedback to the Commission must do so by 21 March 2025 using this link.

The results of this consultation may not provide any quick or easy solutions to the difficulties that have been encountered as a result of the MDR and IVDR. However, it is an opportunity for the European Commission, and later the EU legislators, to reconsider objectives, understand the needs and difficulties of the industry and set realistic targets for all stakeholders. Continue Reading The European Commission launches public consultation on the MDR and IVDR