The UK MHRA has updated its guidance on medical devices: EU regulations for MDR and IVDR (Northern Ireland).
About the EU Medical Device Regulations
The Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively.
Under the terms of the Northern Ireland Protocol, from 1 January 2021, the rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain (England, Wales and Scotland).
The MDR will apply in Northern Ireland from 26 May 2021, and the IVDR will apply in Northern Ireland from 26 May 2022, in line with the EU’s implementation timeline.
The MDR and IVDR place additional obligations on importers
The update concerns the addition of a new section on importer requirements.
What is the definition of an importer?
The MDR and IVDR define an ‘importer’ as “any natural or legal person established within the Union that places a device from a third country on the Union market”.
This means that you’ll become an importer if you’re the one bringing goods for the first time into Northern Ireland from either Great Britain or another non-EU country and placing them on the Northern Ireland market.
Who can be an importer?
An importer can be an individual or a company, such as a retailer, retail outlet or wholesaler, who is placing the device on the market. There may be cases where the end customer, such as a hospital or dentist, might be considered to be the importer. You will need an address in Northern Ireland to be considered “established”.
For more information, see the new MHRA guidance for retailers supplying devices into Northern Ireland.
What legal obligations are there for importers?
The MHRA update lists eleven obligations for importers. They include the need to make sure:
- that the device has been CE marked or, for devices (from GB) for the Northern Ireland market only, also has a UKNI marking
- that the EU declaration of conformity of the device has been drawn up
- a manufacturer is identified and that, where relevant, an authorised representative has been designated by the manufacturer
You can read the list of eleven obligations on this page under the heading ‘Legal obligations’.
Full importer obligations can be found in Article 13 of the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
Source: MHRA website