Post-Brexit Medical Device Regulatory Compliance – UK MHRA Guidance
What the Medicines and Healthcare Products Regulatory Agency Does?
MHRA is an executive agency in the Department of Health and Social Care. The Medicine and Healthcare products Regulatory Agency regulates medicines and devices for transfusion in the UK. MHRA holds medicine, medical device, and blood components.
Following the UK Medicines and Healthcare products Regulatory Agency also known as MHRA, from January 1, 2021, the UK MHRA will undertake the responsibilities for the UK market.
Previously under the EU, led to several changes regarding how medical devices are placed in the Great Britain market; it is important to note that different rules will apply for Northern Ireland after the transition period compared to Great Britain.
Statutory Pharmacovigilance Guidance
EU guidance on good pharmacovigilance practices (GVP) continues to apply in the UK. MHRA guidance note on exceptions and modifications to EU guidance that apply to UK MAHs and the MHRA is available here. Full guidance is available in MHRA, and MHRA publishes an EU guidance note.
What to include in MHRA registrations?
Manufacturers must submit company, device, and UK Responsible Person information to MHRA. In addition, companies must set up accounts before entering registration data into the online system. MHRA only accepts device registrations from companies in the UK or Authorized Representatives in Northern Ireland. New MHRA guidelines also include examples of registration information for custom-made devices and system and procedure packs. Manufacturers should also be aware that the MHRA will accept device registration from companies established in the UK or from Authorized referred presidents based in Northern Ireland to register their devices with MHRA’s Device Online Registration System.
Which legislation will apply to Great Britain?
At present, devices are regulated according to the below directives –
- Under Directive 90/385/EEC on active implantable medical devices (EU AIMDD),
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).
Even after the transition period, these directives effective in UK law through the UK MDR 2002 will continue to apply. While the MDR will fully apply to the EU Member States from May 26, 2021, and IVDR from May 26, 2022, these regulations will not take effect until after the transition period with the EU has ended. Hence, these regulations will not be EU law. These regulations will automatically hold on to by the EU Withdrawal Agreement Act. Therefore these will not automatically apply in Great Britain.
What are the essential 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 January 1, 2021. Manufacturers can refer to the guidance on the UKCA mark and must achieve Conformity Assessment Bodies for information on complying with the relevant product marking and conformity assessment requirements for medical devices, including IVDs, must be completed.
All MDs and IVDs placed on the UK market must register with the MHRA starting January 1, 2021.
A grace period for registration includes the below deadlines
- Class IIIs, Class IIb implantables, and all active implantable 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 currently necessary to register with the MHRA will not be eligible for the 12-month grace period. To launch a device in the Great Britain market, manufacturers outside the UK will need to designate an authorized representative or person; who will take responsibility for the product in the UK. He is known as the “UK Responsible Person,” as discussed below.
In the case of a Northern Ireland-based manufacturer whose device is registered with the MHRA for Northern Ireland, it can freely flow between Northern Ireland and Great Britain. The device will not need any additional registration in Great Britain.
Until June 30, 2023, the CE mark will continue to be used & recognized. Also, the certificates issued by European Economic Area (EEA)-based Notified Bodies will remain valid for the Great Britain market until that date.
European Economic Based NB will use the transition, the UKCA mark (a new UK product marking), for all devices on the Great Britain market after June 30, 2023. On June 30, 2023, CE-mark devices must comply with the new legislation and possess the UKCA, including a labeling change. Since the EU, EEA, or Northern Ireland markets will not recognize the UKCA mark, products requiring a CE mark will still need a CE mark for sale in these markets.
After July 1, 2013, The Great Britain market will accept devices labeled with CE and UKCA marks. However, the guidance document does not clearly state if the name and place of business for the importer and UK Responsible Person are added to the label. Annex I of the European Directives or Regulations, where each labeling requirement will be linked to the EU market. It indicates that the UKCA requirements might likely include UK addresses with user information.
Post-market surveillance and vigilance
Once a medical device has been placed on the UK market, your role does not end there as a manufacturer. You should submit vigilance reports to the UK MHRA on incidents involving your device. And you should continue to take appropriate safety actions wherever/whenever necessary. For as long as the device is in use, you must ensure that it meets proper safety and performance standards.
Role of the UK MHRA
As the UK’s central medical device market oversight authority, the MHRA will continue to perform market surveillance. Make 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 UK MHRA. New legislation requiring parliamentary approval will formalize this proposed guidance.
Role of the UK Responsible Person
Before placing the device on the UK market
- The UK Responsible Person will be responsible for the registration of the device.
- He must ensure the Declaration of Conformity (DOC) and technical documentation existence, with copies of relevant certificates.
- Providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device when required.
- Cooperating with MHRA for corrective and preventive measures to eliminate or alleviate the risks posed by devices.
- The UK Responsible Person shall carry out specified tasks concerning the manufacturer’s obligations.
- He will also make sure that appropriate conformity assessment procedures are followed.
- However, placing the device on the market is typically the importer’s responsibility. It would seem that the importer and the UK Responsible person often are the same person, leading to an undesired mixing of roles.
- The UK responsible person can immediately inform about complaints and reports from patients, users, and health care professionals about the suspected incidents for the device for which they are responsible.
Impact of the new UK regulatory system on medical devices
Post-Brexit, the UK regulatory system envisions self-certification for Class I self-certified devices or general IVDs. The UKCA mark can be self-affixed once compliant with the new legislation.
The higher-risk medical devices and IVDs, need approval from the UK Approved Body, and a UKCA certificate to affix the UKCA mark is mandatory. Already 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, EUU-based notified bodies will not issue UKCA certificates.
Regarding the EU market, UK-based Notified Bodies will no longer 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. UK-based manufacturers must have an Authorized Representative and importer located in the EU-27, resulting in both a costly and time-consuming process.