On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA is “focused on providing
Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators. To
In this episode of Covington’s Life Sciences Audiocast, Sarah Cowlishaw and Ellie Handy discuss the recent changes to the MDR and IVDR. Our speakers discuss the European Commission’s recently adopted Regulation (EU) 2023/607, which extends the transitional periods in the EU Medical Devices Regulation (EU) 2017/745 (the “MDR”) for certain eligible devices CE marked
To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”). We set out the top 10 questions to think about when assessing how the changes to the MDR and IVDR may impact you and your medical devices.
Continue Reading How do the recent changes to the MDR and IVDR impact you and your medical devices? — Top 10 Questions
Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years, including the issues surrounding the
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation
Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.
The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.
It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.
Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.
The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before). Low notified body capacity is a key contributing factor for the transition delays.
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme – Roadmap.” It builds on the Government response to consultation on the future regulation of medical devices in the UK and follows on from the Software and AI as a Medical Device Change Programme, which was published in 2021. The MHRA has provided deliverables, which map out a course for change to the regulation of this sector.
Continue Reading Change is Coming for Software and AI Medical Devices in the UK