A lot has been happening in the world of medical devices over the last few months – we set out some key points below.

Progressive roll-out of the IVDR

As discussed in our previous blog, the European Commission published a proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (“IVDR”) by amending the transitional provisions for certain products. This was agreed by the European Parliament and the Council without any amendments to the Commission text. It has now been formally signed, and published in the Official Journal as Regulation (EU) 2022/112.

Continue Reading Update on the MDR and IVDR in the EU

On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support safe innovation and ongoing access to products”.

The current framework for medical devices in the UK is set in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has now been substantially updated by the Medical Devices Regulations. Whilst the new Medical Device Regulations 2017/745 have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law. The Regulations will, however, apply in Northern Ireland under the terms of the Northern Ireland Protocol. Similarly, the In Vitro Diagnostic Medical Devices Regulations 2017/746, due to apply in the EU from 26 May 2022, will not apply in Great Britain, but will apply in Norther Ireland.

The MHRA was heavily involved in the development of the new EU legislation and believed in the need to update the current Medical Device Directives and the UK Regulations. There have been concerns that as the updates to the EU regime do not apply in Great Britain, the UK may be seen as a less attractive country in which to develop and market medical devices, or that it does not protect patients to the same extent.

As such, the consultation focuses on patient safety and innovation (which are not mutually exclusive) whilst recognising that gaining and maintaining competitiveness in a global market will best be supported by alignment with internationally recognised best practice and standards, including greater alignment with the new EU Regulations.

Continue Reading Consultation on framework for medical devices in UK

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!

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

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)

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.

Continue Reading Medical Devices and Compulsory Insurance in the EU