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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 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This resolution acknowledges that the MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices in the EU, to ensure higher standards of safety, transparency and clinical performance, while also fostering innovation in the sector. However, it is also acknowledges that significant challenges have been encountered in implementing the MDR and the IVDR. These include delays, shortages, and difficulties in navigating the regulatory procedures. The particular impact on small and medium sized enterprises (SME) and on patient care are highlighted.

The lack of harmonised procedures for Notified Bodies, and the lack of harmonised interpretation of the MDR and IVDR between Notified Bodies, is also noted, and the fact that this leads to unpredictable timelines for certification and market access.

The Parliament resolution therefore seeks to address some of these difficulties. Continue Reading European Parliament resolution on need to revise the Medical Devices Regulation

Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.

The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL). These revisions are part of the overall EU pharmaceutical strategy that was announced by the European Commission in November 2020, with the core GPL amendments proposals published in April 2023.

With the vote, the European Parliament has now endorsed the position adopted by the Environment, Public Health and Food Safety Committee on 19 March 2024. The Committee had amended the Commission’s proposal in several respects. Overall, the Parliament’s amendments are aimed at encouraging and fostering more innovation in the EU, and industry will be pleased that some of its core concerns have been addressed, although significant areas of uncertainty remain.

The adoption of the package is likely to be delayed by the European Parliament elections in June this year. The reforms will be taken up by the new Parliament after the elections, and so it is difficult to see any agreement being reached before 2026.

Below is a summary of the Parliament’s position in some of the key area. This summary is, however, not exhaustive but rather highlights topics that have been subject to increased interest for industry and extensive discussions in the European Parliament.Continue Reading European Parliament backs reforms to the EU Regulatory Framework for Medicinal Products