The MHRA has updated its guidelines for “Regulating medical devices in the event of a no-deal Brexit – What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal” on 18th September 2019…
The guidance offers greater clarification on who can become a UK Responsible Person. The term Person can be either a sole trader or a company but it must be UK based.
“If a company establishes itself as a UK Responsible Person, the responsibilities of the UK Responsible Person would fall to the company as a whole. This is the same situation as for an EU Authorised Representative.
If you are a UK-based importer and you wish to place a device on the market, you must have the authority from the manufacturer before doing so. This means that you will become a UK Responsible Person.”
While there is a grace period for the appointment of a UK Responsible Person (4 months for Annex List A IVDs, longer for non-Annex List A) we would recommend having conversations with companies who can offer the UK Responsible Person service as early as possible.
IVDeology Ltd is a UK based company which have a highly experienced team of Regulatory, Quality and Technical experts who can act on behalf of non-UK based IVD and Medical Device manufacturers. We are offering our UK Responsible Person services to all IVD and Medical Device Manufacturers offering guidance and support during the Brexit transition, as well as UK and EU IVD and Medical Device Regulation changes.
For further information contact [email protected] so that one of our team can discuss how we can help you.
Are you looking for an EU Authorised Representative to place IVDs and Medical Devices into the European Market? contact us for further information on how we can help.