Sharon Lamb, Jana Grieb, Dr Deniz Tschammler and Bella North from McDermott Will & Emery analyse the current regulatory environment for medical device manufacturers following announced delays to UK and EU implementing regulations.
In late 2022, the EU and UK announced proposed delays to the implementation of new medical device regimes in both markets, setting new timelines for compliance by medical device manufacturers.
The European Union Medical Device Regulation (EU MDR) was first enacted in 2017. At the time, the implementation periods looked ambitious but achievable. The new law was intended to apply in the United Kingdom, and the UK regulators had played a key role in the drafting of the EU MDR.
In practice, implementation in both the European Union and United Kingdom was severely affected by a number of converging factors, including Brexit, COVID-19, supply chain issues, and a lack of designated notified bodies to certify devices. These issues reached a head in 2022.
In July 2022, MedTech Europe, the European trade association for medical technology reported that, based on a survey it had taken of the industry, EU MDR certificates had not been issued for more than 85% of devices previously certified under the old law, and more than 50% of survey respondents indicated that portfolio reductions were planned. Towards the end of 2022, there were multiple calls for an extension to the implementation timetable. In December 2022, the European Commission announced that changes would be made to the implementation transition of the EU MDR. The formal proposal for the regulation was issued on 6 January 2023 (the Commission Proposal).
As a result of Brexit, UK law was changed to allow a transitional period for the placing of EU marked devices in the Great Britain market and to introduce a new certification for medical devices in the market by 2023, known as the UK Conformity Assessed (UKCA) mark. In June 2022, the UK government issued proposals to change the UK medical device legislation (the New UK MDR). These proposals were broadly similar to the changes in the EU MDR and were expected to be published in Autumn 2022. The publication of the draft New UK MDR was delayed, and the implementation of the UKCA mark has been affected by a shortage of approval bodies. These cumulative challenges led to calls by the industry for an extension to the current transition period and a delay to the new law.
In late 2022, the UK Government announced delays to the transition period and a new timeline for the New UK MDR. The delays have not yet been formalised in law, but it has been proposed that the new law will not come into force until July 2024, so there will be a longer transitional period in which EU marked devices (under both the old EU and new EU law) will continue to be allowed to be placed on the Great Britain market.
The proposed new EU transition periods
The 6 January Commission Proposal points out that, despite considerable progress over the past years, the overall capacity of notified bodies remains insufficient to carry out the tasks required in the conformity assessment procedures. In addition, many manufacturers are not adequately prepared to meet the strengthened requirements of the EU MDR by the end of the current transition periods. The Commission concludes that these circumstances threaten the availability of medical devices on the EU market.
The Commission Proposal aims to resolve these issues. It provides, inter alia, extensions to the transition periods stipulated in Article 120.3 of the EU MDR. In particular, the Commission Proposal contains the following suggested amendments to the EU MDR and In Vitro Diagnostics Regulation (IVDR):
- Longer transition periods that vary based on the respective device’s risk classification:
- High risk devices (Class III and Class IIb) will be required to conform to the EU MDR by 2027 at the latest.
- Medium and low risk devices (Class IIa and Class I) will be required to conform to the MDR by 2028 at the latest.
- To benefit from the extended transition periods, the manufacturer must have commenced the steps necessary for the device’s compliance with the EU MDR before the relevant deadline.
- Certain limitations with regard to the benefit from the transitional periods provided in the EU MDR will continue to apply. In particular, a device may not benefit from the transition period if it has undergone significant changes in design or intended purpose, or if it presents an unacceptable risk to health or safety.
- By 26 May 2024, manufacturers must have put in place a quality management system in accordance with Article 10, paragraph 9 of the EU MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the EU MDR requirements.
- The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Council Directives 90/385/EEC and 93/42/EEC.
- Subject to certain conditions, the validity of certificates that have already expired since 26 May 2021 shall be extended.
- The sell-off date currently provided for in Article 120, paragraph 4 of the EU MDR shall be removed altogether. As a result, devices previously placed on the European Economic Area (EEA) market on the basis of CE certificates issued under the former regime may in theory remain on the EEA market indefinitely.
- The same applies to in vitro diagnostics: the current sell-off dates in Article 110, paragraph 4 of the IVDR—25 May 2025 to 26 May 2028—are supposed to be deleted. As a result, devices placed on the market before the end of the transition period laid down in Article 110, paragraph 3 of the IVDR can be made available on the market without time restrictions.
The proposal still needs to move through the EU legislative procedure, during which it may still be amended. In particular, the EU Parliament and Council of Ministers must approve the changes. Given the urgency, this is proposed to be undertaken under an accelerated procedure to ensure that the proposed adjustments eliminate any risk of shortages in the short term and ensure access for patients most in need of these products.
The new UK transition periods
The current UK medical device legislation transitional provisions, which were adopted at the time of Brexit, allow for the recognition in Great Britain of CE marked devices and certificates issued by EU-recognised Notified Bodies until June 2023. From 1 July 2023, the law states that all medical devices placed on the GB market must have a UKCA mark. This position is still reflected in the current Medicines and Healthcare products Regulatory Agency (MHRA) website guidance. In October 2022, the MHRA proposed delays to the June 2023 deadline, but, at the time of going to press, the Agency has not yet updated the guidance on its website.
The October 2022 proposals need to be read alongside the UK Government’s consultation on the New UK MDR, which was initially meant to come into force on 1 July 2023. The New UK MDR proposed transition periods that would permit EU originating, CE marked devices to continue to be placed on the Great Britain market.
According to the MHRA’s October 2022 proposals,
- CE marks will continue to be accepted in GB market until July 2024.
- The requirement to obtain a UKCA mark will be delayed until July 2024.
- The New UK MDR is expected to be published in Spring 2023, and come into effect from July 2024.
Assuming the New UK MDR is now enacted in line with these proposals, it appears that the original, already generous transition periods will be extended by a further year.
UK transition arrangements
The original transition timelines for the New UK MDR allow for the following transitional arrangements.
For UKCA marked devices, at a minimum, products can be placed on the market until either the relevant certificate expires, or for three years (in the case of general medical devices) or five years (in the case of in vitro diagnostics or IVDs), whichever is sooner.
In relation to CE marked devices (under the EU MDR or EU IVDR), products can continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner.
If the MHRA consultation proposals are implemented in the New UK MDR (due to be confirmed in the coming months) and the October 2022 proposals are enacted, depending on the device’s certificate date and basis, the latest dates by which legacy devices may be placed on the Great Britain market are as follows:
- June 2027 for UKCA devices (previously June 2026)
- June 2027 for EU MDD devices (previously June 2026)
- June 2029 for EU IVDD devices (previously June 2028)
- June 2029 for EU IVDR and MDR devices (previously June 2028).
The dates in parentheses also show the initial transition periods proposed under the UK MDR.
There are a lot of “ifs and buts” in these timelines. The new law has not yet been issued in draft form and, somewhat confusingly, at the time of going to press the MHRA guidance continues to reflect the current law, still specifying June 2023 as the deadline for transition. It is also unclear how the October 2022 proposals will affect the transition time lines. The draft of the New UK MDR is due to be published in early 2023 and will be eagerly awaited by the medical device market.
Many questions therefore remain unanswered and manufacturers looking to certify new devices before June 2023 have several options to consider.
There is, however, one piece of good news for manufacturers who place their devices on the EU market. It appears that these certificates will continue to be accepted in the United Kingdom for a longer time period and that this will apply for certificates that are extended under the Commission Proposal. Given that many EU certificates under the old EU law were due to expire in 2024, if the October 2022 proposals are enacted, this may be welcome relief for manufacturers. This means that manufacturers with legacy devices under the old EU law may benefit from certification under the current UK law, with a UKCA mark, given this regime remains the same as the old EU law.
Good news in Great Britain for international manufacturers
In a statement issued on 16 December 2022, the UK Government signalled its intention to publish new proposals on international recognition routes and routes for innovation and system capacity in February 2023. These announcements are likely to set out proposals on e-labelling and the recognition of other jurisdictions, such as the United States.