The MHRA (Medicines and Healthcare products Regulatory Agency) issues new version of guideline for placing medical devices on the Northern Irish Market
The United Kingdom has left the European Union, but Northern Ireland maintains a special position.
In order to keep an open border between the Republic of Ireland and Northern Ireland, the Northern Ireland Protocol provides that European product legislation remains applicable. This means that CE-marked medical devices can be placed on the Northern Irish market.
Furthermore, the UKNI marking is required if a UK Notified Body has carried out the conformity assessment. Certain medical devices placed on the market in Northern Ireland must be registered with the MHRA. Class I medical devices that are brought onto the market by Northern Irish manufacturers and Authorised Representative (AR) based in Northern Ireland must, as before, be registered, as the registration deadlines for these products do not apply.
As for the other product classes, medical devices must be registered on the dates below:
- Class III and Class IIb implantable products as well as all active implantable medical devices must be registered from May 1st, 2021,
- other Class IIb products and all Class IIa products must be registered from September 1st, 2021.
In particular, the role of importers is now clear with a reference to the Medical Device Regulation (MDR):
- importers must comply with Article 13,
- distributors have to comply with Article 14
- and manufacturers or their AR must comply with Article 15 on the “person responsible for compliance”
These requirements will apply to medical devices from May 26th, 2021.
Vice versa placement of medical devices on the EU market with CE-marking continues
Conversely, in order to place a medical device on the EU market, a Northern Irish manufacturer must adhere to the relevant EU legislation and affix a CE mark to prove conformity. The UKCA mark (UK Conformity Assessed) is not recognised on the EU market.
If you have chosen a UK based Notified Body to perform a conformity assessment, the following applies:
If your medical device was placed on the EU market before January 1st, 2021, it can remain on the EU market under the terms of the Withdrawal Agreement. You can only place a product on the EU market if it has been assessed by a notified body recognized by the EU.