Why this is important to Wisconsin businesses: Wisconsin companies should be aware of the regulatory changes, which take effect in 2021 through 2023.
There has been a significant change from earlier pronouncements, when the UK indicated it would incorporate all key elements of the incoming EU medical device and in vitro diagnostic (IVD) regulations into UK law. This new mandate is the appointment of a specific UK Responsible Person (UKRP). From Jan. 1, 2021, all medical devices, including IVDs, for sale on the UK market will need to be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA). There will be a grace period of four to twelve months for registering, according to risk class.
Starting Jan. 1, non-UK manufacturers must have a registered place of business in the UK to register devices being sold in the market, and must designate a UKRP that is established and physically located in the UK, with the registered business address used for official communications.
The UKRP must register with the MHRA. Responsibilities include registering devices with the MHRA and ensuring that a Declaration of Conformity has been drawn up and that technical documentation, device marks and labels exist. Importers and distributors representing the manufacturer can act as a UKRP and liaise with the MHRA.
The UKRP will also play a critical role in post-market device surveillance, working with the manufacturer and the MHRA to implement corrective and preventive actions associated with complaints and related safety issues. There are two scenarios for non-UK manufacturers:
- Where a non-EU manufacturer already uses a UK-based authorized representative, it is likely that the representative will start acting as UKRP. The UKRP can also be a separate entity from the importer.
- If a non-EU manufacturer uses an EU-based representative, they will need to appoint a UK-based UKRP in parallel with the European representative.
CE marks and the certificates issued by European Economic Area-based notified bodies will remain valid until the end of June 2023. Beyond that, companies will need a UK Conformity Assessed (UKCA) mark to sell devices in Great Britain. In January 2021, the MHRA will designate UK Conformity Assessment Bodies to assess whether products meet the UKCA mark requirements. Those UK notified bodies currently designated under EU directives on medical devices, IVDs and active implants will automatically become UK-approved bodies in January, giving them the power to conduct conformity assessments. The MHRA has already written to centrally authorized products marketing authorization holders to inform them of the UK intention to grandfather UK marketing authorizations. It won’t be necessary to modify existing labelling to add the UKCA mark until July 1, 2023. Dual labels with the CE and UKCA marks will be acceptable.
For new devices, a UKCA assessment body will need to a conduct an assessment for compliance with the UKCA mark requirements. Existing UK notified bodies are likely to continue as designated assessor for UKCA conformity assessments.