Reuben Jacob, partner and head of life sciences, and Dr. Janet Strath, paralegal, both from legal firm Maucher Jenkins, look at what the recent guidance issued by the UK Government on the Brexit implementation period and the life sciences sector will mean for regulation and compliance.
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Devices in microbiological laboratory
Devices in microbiological laboratory
The Withdrawal Agreement provided details of a transition or implementation period starting from the UK’s exit from the Union on 29 March 2019 at 11.00 pm and ending on 31 December 2020. During that period, all EU rules and regulations will continue to apply in the UK (subject to any variations or exceptions contained within the Withdrawal Agreement). On 6 August 2018, the UK Government published guidance confirming that during the implementation period:
- Batch release testing and Qualified Person certification can continue in the UK, with this being recognised in the EU and vice versa;
- Marketing Authorisation Holders (MAHs) and Qualified Persons for Pharmacovigilance (QPPVs) will continue to be able to be based in the UK and will have access to EU markets;
- UK based firms can continue to apply for Marketing Authorisations via either the centralised or decentralised procedures; and
- Conformité Européene (CE) marking will continue to be used for medical devices and recognised for the UK and EU markets, and there will be no need for UK-based companies to appoint an EU-authorised representative in the EU. UK notified bodies can continue to conduct third-party conformity assessment tests in the UK and the results will continue to be used and recognised in the UK and EU markets.
In its technical guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) further explained that the UK would be able to participate in reviewing new Marketing Authorisation applications, but it would not be able to act as the leading authority or Reference Member State (RMS) for risk assessments, examinations, approvals and authorisations pursuant to Article 123 of the draft Withdrawal Agreement. The Coordination Groups for Mutual Recognition and Decentralised Procedures have confirmed that transfer of an RMS (from the UK to another member state) will not be permitted before an MA application procedure is concluded. Consequently, the guidance states that applicants for Marketing Authorisations which are still being processed and who “wish to ensure that procedures involving the UK as RMS will be completed by 29 March 2019 are requested to submit responses to outstanding lists of questions as soon as possible”.
During the implementation period, the MHRA and the Veterinary Medicines Directorate (VMD) can attend European Medicines Agency (EMA) and EU Committees, and participate in all discussions that are relevant to the UK. However, “the exact nature of this participation is a matter for further discussion”. The MHRA and the VMD will carry on discussing issues with EU counterparts and sharing information as they currently do (including continued access to EMA and EC databases and sharing of vigilance data) but some elements of the MHRA’s and the VMD’s role will change; for example, the UK will no longer have a vote in any decision making by the EMA and EU committees.
The EU Medical Devices Regulation (MDR) will be fully applied from May 2020 (during the implementation period) but the new EU Regulations for in vitro diagnostic (IVD) medical devices does not apply until May 2022 (outside of the implementation period). However, the MHRA notes that elements of both new devices regulations have applied in the UK since May 2017, meaning that medical devices (including IVDs) can already be legally placed on the UK market provided that they conform to the new regulations, invoking all relevant requirements.
Companies should therefore budget for the additional work required to place a device on the European market and keep it there, which will involve additional cost and time. New certificates will need to be issued for devices that did not need CE certification by a notified body before, such as reusable surgical instruments and software; the compliance of all medical devices will have to be assessed against the current requirements and standards, and all resources connected to outsourcing regulatory, clinical or certification activities will be a trifle busy. Manufacturers will also have to put measures in place to compensate for the fact that under the MDR, users can claim compensation for damage caused by defective devices.
Although the UK Government is confident that it is unlikely that the UK will leave the EU without a Brexit deal, on 23 August 2018 the Department of Health and Social Care released a guide explaining how medical devices would be regulated in the event of the UK becoming a third country (used in Treaties to mean a country that is not a member of the Union and is not party to an agreement between two other countries) by 30 March 2019, and more technical notices are expected to be published next month.
As regards medical devices on the EU market, in the event of a hard Brexit all of the UK notified bodies would no longer be able to conduct conformity assessment in accordance with EU rules in relation to medical devices. The CE marking issued by these notified bodies prior to 29 March 2019 would also cease to be valid. This means that any medical devices which have been CE marked by UK noticed bodies and placed on the EU market will, after Brexit, need to be CE-marked by a Notified Body licensed by the competent authorities of one of the 27 EU Member States.
As regards medical devices on the UK market, the Government has stated that after 29 March 2019 if there’s no deal it will continue to recognise the CE Mark for a time-limited period, during which time such devices would be accepted on the UK market if they meet all EU requirements, which for all but the lowest-risk devices would include certification by EU notified bodies.
This will mean additional resources will need to be allocated in order to seek approval in the UK as well as the EU market, which could mean that small to medium sized medical device companies will suffer.
As well as the export market, the UK Government has also undertaken analysis of supply chains for medical devices and clinical consumables identifying the proportion of product routinely imported into the UK from other countries in the EU. In a letter to suppliers of medical devices and clinical combustibles, the Health and Social Care Secretary Matt Hancock said that:
- separate contingency plans are being developed;
- stock holding at a national level will be increased; and
- further information will be provided to industry in September.
In the event of no Brexit deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Sharing of these common systems and the associated exchanges of data between the UK and EU/EEA countries would cease, and the UK would need to have its own processes and systems to manage UK human medicines and device regulatory activities. The UK Government has said that it is currently developing some new systems for March 2019. However, developing a new framework risks making the UK unattractive for companies because of the extra costs involved. Because the UK’s trade depends so much on EU regulatory activities and networks to make it frictionless, it is difficult to assess how medical devices would continue to be traded when those frictions return. How well the UK rises to these challenges remains to be seen.
