The day is finally here! Four years after it entered into force, the Medical Devices Regulation (MDR) is applicable today, the 26 May 2021. We have discussed the aspirations and implications of the MDR, we have commented on the slow rate of implementation, and we have heard, and share, some of the frustration expressed by companies as they have prepared for today. From today, industry, regulatory bodies, external advisors and customers will be able to experience the consequences of the radical reform of the medical devices regulatory framework that has been introduced by the MDR.

We have published several blog posts on the key changes and progress of the implementation of the MDR. In this post, now the MDR is officially applicable, we briefly cover where we stand in relation to some of the issues and concerns for the industry. The European Commission recently said that “the 26th of May is not an end date” and we couldn’t agree more. While the MDR was focused on increasing patient safety and the oversight of devices, there is still a lot of work to be done, and there remains a number of outstanding questions. We believe there will need to be a great deal of flexibility by all parties over the coming months in other to avoid disruption for patients.


Continue Reading The EU Medical Devices Regulation applies today!

On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement). This was the result of many months of detailed negotiation within an increasingly difficult political environment. The final Agreement does not cover all of the aspects about which life sciences companies have been concerned, and there are areas that will likely be the subject of further discussion during the implementation of the Agreement. However, many view the Agreement as being an important first step in the UK’s continuing relationship with the EU. We set out below a summary of the key aspects of the Agreement relevant to life sciences companies.

Continue Reading The EU-UK Agreement and the implications for life sciences companies

The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency’s (EMA) role in crisis preparedness and management for medicinal products and medical devices. According to the European Commission, the COVID-19 pandemic demonstrated that the EMA has a limited ability to manage availability issues relating to medicinal products and medical devices and lacks a framework for crisis response. The aim of the proposed Regulation is to set up such a framework which will allow the EU to respond effectively to health emergencies through broader engagement with the relevant stakeholders in a coordinated and timely manner to achieve the over-arching objective of public health protection.
Continue Reading Draft EU Framework for Coordinated Approach to Addressing Emergency Public Health Threats

In this post, updating our series of posts on the implementation of the EU Medical Devices Regulation (MDR), we take a look at the latest steps taken by the EU institutions to ensure the MDR is fully applicable by May 2021.

Despite the summer break and the difficulties caused by the pandemic, the Medical Device Coordination Group (MDCG) and the European Commission have endorsed a number of significant guidance documents relevant for manufacturers, national authorities, notified bodies and expert panels. In addition, the fourth implementing act, required by the MDR, has been adopted by the European Commission.
Continue Reading EU Medical Devices Regulation: Adoption of further guidance documents

Although the date of application of the Medical Devices Regulation (MDR) has been delayed by a year, to May 2021, the EU institutions continue to work on its implementation to ensure that the new framework is workable in time for the revised deadline.

In this post, which is part of our series of blog posts covering the implementation of the MDR, we set out a summary of key recent developments. As indicated below, as well as our previous posts, there are several important steps that still need to be taken with regard to MDR implementation. Similarly, many companies are still working on their own compliance. While industry undoubtedly faces a range of challenges in the context of the ongoing health crisis, and the delay provides some welcome breathing room for many, it will nevertheless be important to continue to progress MDR preparedness so that supply is not disrupted.
Continue Reading EU Medical Devices Regulation: implementation progress during the pandemic

The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.


Continue Reading UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients

With only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020, the Commission has taken various steps towards its implementation. As we have discussed, while there are lots of good intentions, there is still much to be done –  although it now seems that a delay to the May date is on the horizon.

Last week, the MDCG published a number of guidance documents providing much needed clarity on some of the “priority” areas. These are set out below, with particular comments on the guidance relevant to the transitional provisions under the MDR.


Continue Reading Two months to go: Latest on implementation of EU MDR (Part 2)

There are now only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020. We have previously published updates on various implementation activities, and the concerns of industry and stakeholders that the deadline has been fast approaching but that there remains a huge amount to be finalised. The difficulties surrounding Brexit, and now the coronavirus pandemic, only add to these concerns. With the short amount of time remaining, we set out in this series of posts a summary of recent key developments.

As expected, the recent activity is focused on the MDR, and does not, on the whole, address the In Vitro Diagnostics Regulation (IVDR), which is due to be applicable in 2022. While this is a pragmatic approach from the institutions given current timing, it remains the case that IVD manufacturers have little clarity on how the IVDR will operate, and it seems, are unlikely to obtain any in the near future.


Continue Reading Two months to go: Latest on the implementation of EU MDR (Part 1)