The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.

Separately, the MHRA has published a work programme on software and AI as a medical device to deliver a regulatory framework that makes sure that the UK is the home of responsible innovation for medical device software.  Any legislative change proposed by the work programme will build upon the wider reforms to medical device regulation being consulted upon as a part of the Consultation.

The MHRA intends that any amendments to the UK medical device framework will come into force in July 2023.  This aligns with the date when UKCA marking will become mandatory in the UK and when EU CE marks will no longer be recognized.  The MHRA has made clear that it will provide adequate transition periods before adopting any new requirements.

All interested parties are encouraged to contribute to shaping the future regulation of medical devices in the UK by responding to the MHRA’s consultation before the deadline (25 November 2021).

Continue Reading Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized

The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline).  The Draft Guideline applies to fixed combination medicinal products containing two or more active substances within a single pharmaceutical form.  The active substances may be known active substances or substances that have yet to be authorised in the EU.
Continue Reading New Draft EMA-Guideline On Clinical Development Of Fixed Combination Medicines

On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the application of the exceptions to the disclosure of information, and invites stakeholders to comment.
Continue Reading EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation

 This post originally appeared on our sister blog, Covington eHealth.

The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation. The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health
Continue Reading Summary Report of European Commission’s mHealth Consultation Published