Medical Devices

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Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.Continue Reading UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.Continue Reading Extension to EU MDR transition periods finalised

It is well known that there are significant problems with the implementation of the Medical Devices Regulation 2017/745 (MDR), in particular notified body capacity and the vast number of products that need to go through the new regime before the end of the transitional period. After sustained pressure from companies and Member States alike, late last week (on 9 December), the Commission finally confirmed that it intends to extend the transitional period under the MDR. Member States are said to have agreed with the proposals. We set out a summary of what is known so far below.
Continue Reading Delay to EU MDR is on the horizon

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

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!

New EU rules under chemicals and waste legislation require manufacturers and suppliers of products to provide information to a centralized EU database.  These rules may also affect the medical devices industry.

SCIP database

Since 5 January 2021, a new obligation to notify the European Chemicals Agency (“ECHA”) applies to suppliers of articles containing substances of very high concern (“SVHCs”) in a concentration above 0,1 % weight by weight (w/w). The obligation is established under the revised Waste Framework Directive 2008/98/EC (“WFD”) which cross-references Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (“the REACH Regulation”) and provides the basis for the creation of a new database collating information on “Substances of Concern In articles as such or in complex objects (Products)” (known as “the SCIP database”) to which notifications must be submitted under the supervision of ECHA (Article 9 of WFD).

According to ECHA, the aim of the new notification obligation is to ensure that information on SVHCs is available throughout the whole lifecycle of articles and materials, including the waste stage. SVHCs are hazardous substances (e.g., carcinogenic, mutagenic or toxic for reproduction) included in the Candidate List for authorisation of the REACH Regulation. Information submitted to the SCIP database will be accessible to national authorities, waste treatment facilities, supply chain operators and consumers. ECHA intends to publish the submitted information as received, unless the protection of confidential business information can be justified.
Continue Reading EU Chemicals: Obligation to notify ECHA on hazardous substances and its impact on the medical devices industry

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

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)