The UK’s exit from the European Union has a great impact on many companies and the medical device business. The following article summarizes the upcoming changes and explains what to consider for the UDI compliance in the UK.
Since 1st January 2021, products manufactured in the UK and placed on the EU market are considered as “imported from a third country”. This involves changes in the marking and the database registration.
In Northern Ireland, EU MDR and IVDR will apply according with the announced dates (26/05/2021 and 26/05/2022). The CE marking will still apply, but products will have to be registered with the MHRA prior to the placement on the Northern Ireland market.
If you appointed a UK Notified Body for your conformity assessment, the CE UKNI mark must be placed on the medical device. Consequently, this device won´t be admitted on the EU market.
Here are 2 cases containing the main steps for manufacturers in or outside the UK:
- Manufacturer in the EU wants to sell medical devices in the UK:
- MHRA Guideline.
- Appoint a single UK Responsible Person.
- From 01/07/2023: CE Marking will not be valid anymore -> UKCA mark must be obtained, which will exclusively be recognized in the UK.
- Ensure your products comply with the UK MDR 2002 and get accredited by an approved body .
- Register the products in the MHRA Database prior to placement on the UK market. There is no need for re-registration if products were already registered with MHRA prior to 01/01/2021.
- Fees: £100 – for each registration application or for each update within a registration
- Manufacturer in the UK wants to sell medical devices in EU:
- MHRA Guideline.
- Note that the CE marking and certificates issued by EU-recognized notified bodies are accepted until 30/06/2023.
- Appoint an authorised representative and an importer located in the EU.
- Transfer the certificates to an EU notified body.
- Ensure your products have the CE mark.
- Comply with the relevant regulation (MDR and IVDR), especially in regard to the labelling.
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