The MHRA (Medicines and Healthcare products Regulatory Agency) has published a new version of its guide to placing medical devices on the Northern Ireland market.
The United Kingdom has left the European Union, but Northern Ireland occupies a special position.
In order to maintain 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 devices can be placed on the Northern Irish market.
In addition, UKNI labelling 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 placed on the market by Northern Ireland manufacturers and ARs (Authorised Representative) based in Northern Ireland must be registered as before, as the registration deadlines do not apply to these devices.
For other device classes, devices must be registered by the dates below:
- Class III and Class IIb implantable devices and all active implantable medical devices must be registered from 1 May 2021 ,
- other class IIb devices and all class IIa devices must be registered fromthe 1st September 2021 .
In particular, the role of importers is now clear with a reference to the Medical Devices Regulation (MDR) :
- Importers must fulfil Article 13,
- distributors must fulfil Article 14
- and manufacturers or their AR must fulfil Article 15 on the ‘person responsible for compliance’.
These requirements will apply to medical devices from 26 May 2021 .
Vice versa - continuing to place medical devices on the EU market with CE
Conversely, in order to place a medical device on the EU market, you as a Northern Irish manufacturer must comply with the relevant EU legislation and affix a CE marking to demonstrate conformity. The UKCA mark (UK Conformity Assessed) is not recognised on the EU market.
Products that currently require CE marking will continue to require CE marking for sale in the EU.
If you have commissioned a Notified Body based in the UK to carry out a conformity assessment, the following applies:
If your medical device was placed on the EU market before 1 January 2021, it can remain on the EU market under the terms of the Withdrawal Agreement.
You can only place a device on the EU market if it has been assessed by a Notified Body recognised by the EU.
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