In accordance with the guidance posted by the UK Medicines and Healthcare products Regulatory Agency (MHRA), from 1 January 2021 the MHRA will undertake the responsibilities for the UK medical devices market, previously under the EU, leading to a number of changes with regards to how medical devices are placed on the market in Great Britain. It is important to note that after the transition period, different rules will apply for Northern Ireland when compared to Great Britain.
Which legislation will apply to Great Britain?
At present, devices are regulated under Directive 90/385/EEC on active implantable medical devices (EU AIMDD), Directive 93/42/EEC on medical devices (EU MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).
Even after the transition period, these directives which are given effect in UK law through the Medical Devices Regulations 2002 (UK MDR 2002) will continue to apply. While the MDR and IVDR will fully apply to EU Member States from 26 May 2021 and 26 May 2022 respectively, these regulations will not take effect until after the transition period with the EU has ended. Hence, these regulations will not be EU law, automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain.
What are the key requirements to market a device in Great Britain?
- Manufacturers looking to launch a device in the Great Britain market will have a new route to market and product marking from 1 January 2021. Manufacturers can refer to the guidance on UKCA mark and Conformity Assessment Bodies for information on how to comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs must be achieved.
- All medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market need to be registered with the MHRA starting 1 January 2021. A grace period for registration is allowed as follows:
- Class IIIs and Class IIb implantables, and all active implantable medical devices – 4 months
- Other Class IIb and all Class IIa devices – 8 months
- Class I devices – 12 months
- However, manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA will not be eligible for the aforementioned 12-month grace period.
- In order to launch a device in the Great Britain market, manufacturers based outside the UK will need to designate an authorized representative or person (that is established in the UK) who will take responsibility for the product in the UK (referred to as “UK Responsible Person” detailed below).
- In case of a Northern Ireland-based manufacturer whose device is registered with the MHRA for the purposes of Northern Ireland, it can then freely flow between Northern Ireland and Great Britain. The device will not need any further registration in Great Britain.
- Until 30 June 2023, the CE mark will continue to be used & recognized. Also, the certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until that date.
- Post the transition, the UKCA mark (a new UK product marking) will be used for all devices being placed on the Great Britain market after June 30, 2023.
- On June 30, 2023, CE-marked devices must be compliant with the new legislation and must possess the UKCA, which includes a labelling change.
- Since the UKCA mark will not be recognised in the EU, EEA or Northern Ireland markets, products that currently require a CE marking will still need a CE mark for sale in these markets.
- Devices that are labelled with both the CE and UKCA marks will continue to be accepted on the Great Britain market after 1 July 2023.
- However, the guidance document does not clearly state if the name and place of business for the importer and UK Responsible Person must be added to the label. Annex I of the European Directives or Regulations, where such labelling requirements are linked to the EU market indicates a likelihood that the UKCA requirements might include UK addresses with the user information.
Post-market surveillance and vigilance
Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA upon the occurrence of incidents involving their device and must also continue to take appropriate safety action(s), wherever required. For as long as the device is in use, the manufacturers will need to ensure that their device meets appropriate standards of safety and performance.
Role of the MHRA
As the central authority for medical device market oversight in the UK, the MHRA will continue to perform market surveillance and will be able to take decisions over the marketing and supply of medical devices in the UK. The responsibility for the designation and monitoring of UK Conformity Assessment Bodies will continue to lie with the MHRA. New legislation requiring parliamentary approval will formalize this proposed guidance.
Role of the UK Responsible Person
Prior to placing the device on the UK market, the UK Responsible Person will be responsible for registration of the device, ensuring that the Declaration of Conformity (DOC) and technical documentation exist, with copies of relevant certificates. The UK Responsible Person shall carry out specified tasks in relation to the manufacturer’s obligations and ensure that appropriate conformity assessment procedures are followed. However, as placing the device on the market is typically the responsibility of an importer, it would seem that the importer and the UK Responsible Person often are the same person, leading to an undesired mixing of roles.
Impact of the new UK regulatory system:
Post Brexit, the UK regulatory system envisions self-certification for Class I self-certified medical devices or general IVDs such that the UKCA mark can be self-affixed once compliant with the new legislation. However, for higher-risk medical devices and IVDs, approval from a UK Approved Body and a UKCA certificate to affix the UKCA mark is mandated. It is expected that existing UK Notified Bodies with designations under the MDD, IVDD or AIMDD will automatically become UK Approved Bodies through a “roll-over” of their designations. However, UKCA certificates cannot be issued by EU-based Notified Bodies.
Regarding the EU market, since UK-based Notified Bodies will no longer be able to issue CE Mark certificates, most manufacturers will have to move their certificates to EU-27 based Notified Bodies at the earliest possible. A no-deal Brexit would isolate the UK, such that UK-based manufacturers must have an Authorized Representative and importer, both located in the EU-27, resulting in both a costly and time-consuming process.