On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).
- Legislative Background
The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law. Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.
The draft UK MDR 2019 will provide for any such changes to the UK MDR 2002, which are necessary to give effect to the UK’s exit from the EU, for example, they implement the Annexes to the EU Directives on conformity assessment procedures into national law (they were previously merely cross-referenced). Further, the UK MDR 2019 will transpose the key elements of the Medical Device Regulation (EU) 2017/745 and the in vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (EU Regulations) into the UK MDR 2002 (see Parts 2 and 3 of the UK MDR 2019). The timetable for the application of these new device rules would align with the timetable for entry into force the EU Regulations, i.e., May 2020 and 2022 respectively.
The EU Regulations provide for a number of changes to the device regime, including in relation to device classification, safety and performance, labelling, clinical evidence requirements, person for regulatory compliance and device vigilance. They also introduce new obligations for importers and distributors of devices. Once the UK MDR 2019 are adopted, these changes will become part of UK law and will enter into force in 2020 and 2022.
The Guidance confirms that the MHRA will continue to perform market surveillance of medical devices on the UK market. It then provides a general overview of the changes introduced by the UK MDR 2019, including those that stem from the implementation of the EU Regulations into national law post Brexit. For the purposes of this blogpost we have focused on the key transitional changes that will apply on and around ‘exit day’ but will continue to monitor any developments in this space and provide further updates in the future.
The European Commission has made it clear in its Notice to Stakeholders (available here) that in a “no deal” scenario, the EU-27 will no longer recognize UK-based authorised representatives, and this is referred to within the Guidance.
The UK MDR 2019 will introduce a new requirement that a manufacturer who is not established in the UK will need to appoint a UK Responsible Person to act on its behalf. Manufacturers, or their UK Responsible Person, must register with the MHRA prior to placing any devices on the market. The UK Responsible Person will have evidence its status by either providing letter of designation or signed contract showing the name and address of both the manufacturer and the UK Responsible Person. The document must confirm that that UK Responsible Person is “acting with the consent of the overseas manufacturer and the legislation that applies for the devices being placed on the UK market.” Moreover, someone at the UK Responsible Person must be “physically located” in the UK and must be contactable. The UK Responsible Person will also assume the manufacturer’s reporting obligations on device vigilance.
- Device Registration Requirement
After 29 March 2019, all devices placed on the UK market must be registered with the MHRA. The registering entity must have a “registered place of business” in the UK, i.e., it will need to be either the manufacturer or the UK Responsible Person. In case of the latter, the Responsible Person will then assume the registration obligation.
The UK MDR 2019 introduce certain grace periods for this registration requirement, depending on the classification of the device.
- Registration before 29 July 2019: Class III medical devices, Class IIB implantable medical devices, active implantable medical devices and IVD List A.
- Registration before 29 November 2019: Class IIb non-implantable medical devices, class IIa medical devices, IVD List B and self-test IVDs.
- Registration before 29 March 2020: Class I medical devices, general IVDs and Class A IVDs.
The MHRA will require the following registration information:
- Device description in accordance with the Global Medical Devices Nomenclature (GMDN). This requires GMDN membership.
- For Class III devices: medical device name, model, catalogue or reference number.
Companies should also refer to the common data elements as set out in the IMDRF Primary Medical Device Identity information (available here).
The registration, additional and/or subsequent changes to a registration are all subject to a fee of £100. Companies who are already registered only need to confirm that the information is accurate or provide an update, which may also incur a fee. Moreover, companies who are currently registered through an EU Authorised Representative must update the details to include a UK Responsible Person and the fee applies to this update as well. Companies must renew their registration annually and pay a renewal fee of £100.
The MHRA will enter manufacturer information into the Public Access Database for Medical Device Registration (available here), which will list the company name, address, MHRA reference and list the types of registered devices.
- Conformity Assessment and Status of Notified Body Certificates
Manufacturers may continue to place devices on the UK market that have been CE marked pursuant to the EU Directives or EU Regulations.
The MHRA makes clear that it expects the EU-27 to no longer accept certificates issued by UK Notified Bodies after 29 March 2019 and that for devices placed on the market in the EU-27, manufacturers may need to seek re-certification from an EU-27 Notified Body.
Conversely, the MHRA intends to give existing UK Notified Bodies (established under the EU regime) an ongoing legal status, to recognize the validity of certificates that they issued prior to 29 March 2019. Thus, for devices placed on the UK market, the certificates issued by UK Notified Bodies will remain valid after exit day. However, for new devices intended to be placed on the UK market that require conformity assessments after 29 March 2019, manufacturers can only rely on Notified Body certificates issued by an EU-27 Notified Body, following completion of a successful conformity assessment.
- Clinical Investigations and Performance Evaluations
The UK will continue to accept existing clinical investigations approvals, so there is no need to re-submit applications.