The Medicinal and Healthcare products Authority (MHRA) has published an updated version of the guidance describing the new medical device regulations related to Brexit. In particular, the amended document provides additional details regarding the way medical devices will be regulated in Northern Ireland starting from January 1, 2020. According to the guidance, the rules to be applied in Northern Ireland would be different from those applicable in Great Britain.
Conformity Assessment and Marking
First of all, the MHRA emphasizes that upon implementation of the new framework, the UK Conformity Assessed (UKCA) mark introduced under the new regulatory framework will not be applicable in Northern Ireland, as well as in the EU or EEA. Hence, a CE marking would still be required for the medical devices intended to be marketed in the aforementioned regions. The medical device manufacturers would be able to use the new UKCA mark starting from January 1, 2021.
The authority also states that the UK Approved Bodies entitled to carry out the conformity assessment would be responsible for placing the UKCA mark, while the only CE-type mark they will be allowed to grant would be the “CE UKNI” – a special mark to be used for medical devices intended to be marketed in Northern Ireland.
In case the CE mark has been placed on the medical device under the self-certification procedure, it could be also used under the new regulatory framework. At the same time, in order to place the CE mark on an entirely new device intended to be marketed in Northern Ireland or the EU, the manufacturer would have to engage an EU Notified Body duly designated to conduct conformity assessment under the new Directives, since starting from January 1, 2020, the conformity assessment conducted by the UK Notified Body would be no longer applicable in the EU due to the Brexit.
As it was already mentioned before, the UK Notified Bodies would be also entitled to perform the conformity assessment for medical devices intended to be marketed in Northern Ireland. Thus, the medical device manufacturer should engage a UK Notified Body to perform the appropriate conformity assessment. At the same time, the UKNI marking could not be used separately without the appropriate CE mark, while both these marks used together would not be allowed for the EU market.
So, depending on the target region, the medical device manufacturers would have to ensure the device in question is marked accordingly:
- For the general EU market: CE mark,
- For the Northern Ireland market: CE mark + UKNI mark,
- For the UK market: UKCA.
According to the MHRA guidance, the UKNI marking would be required if:
- the medical device is intended to be marketed in Northern Ireland, and
- the medical device in question should be subject to conformity assessment, and
- the UK body would be engaged to perform the conformity assessment.
It is also important to mention that the UKNI marking described hereabove could be also referred to as the “UK(NI) mark” or the “UK(NI)” indication in some of the legislative documents (for instance, in the Northern Ireland Protocol). The authority also states that the separate guidance on the new marking and specific aspects associated thereto would be developed and published by the authority later.
New Medical Device Framework in Northern Ireland
According to the MHRA guidance, the new regulatory framework for medical devices will be introduced in Northern Ireland as prescribed by the Northern Ireland Protocol. As it was already mentioned before, it would be slightly different from one to be implemented in Great Britain. However, the medical devices would still be subject to mandatory registration with the MHRA, and the foreign medical device manufacturer would have to appoint a UK Responsible Person – an authorized representative of the manufacturer in the United Kingdom, which would be responsible for the medical device placed on the market with regard to the all post-market surveillance matters. In the case of Great Britain, medical device manufacturers intended to market their products in Northern Ireland, an authorized representative should be appointed either directly in Northern Ireland or within the EU in general. For non-UK manufacturers, the appointment of a UK Responsible Person is a must starting from January 1, 2021.
The guidance outlines the following core requirements for medical devices that would become effective starting from January 1, 2021, for all medical device manufacturers intended to market their products in Northern Ireland.
- The new European regulations on medical devices – the Medical Devices Regulation 2017/745 (MDR), and the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR) would become effective starting from May 26, 2021, and May 26, 2022, respectively;
- Medical devices intended to be marketed in Northern Ireland would still have to bear a CE marking. Moreover, in a case of conformity assessment carried out by a UK Notified Body, the new UKNI marking would be also required;
- Some types of medical devices would be also subject to registration with the MHRA.
With regard to the last requirement, the MHRA also provides a particular timeline indicating the period after which medical devices would be subject to mandatory registration with the MHRA. Such a period would actually depend on the class of medical devices under the risk-based classification.
- Class I medical devices and general IVDs would be subject to mandatory registration starting from January 1, 2021;
- Class IIa and general Class IIb medical devices, as well as IVD List B products and IVDs intended for self-testing, would be subject to registration starting from September 1, 2021;
- Class IIb (implantable), Class IIIs, all active implantable medical devices (AIMDs), as well as IVD List A products, would be subject to registration starting from May 1, 2021.
Obligations of Medical Device Manufacturers
According to the amended MHRA guidance, medical devices manufactured in Northern Ireland and already registered with the authority to be marketed there could be also marketed in Great Britain without any additional registration. This approach actually simplifies access to the Great Britain medical devices market for the medical device manufacturers based in Northern Ireland.
As it was already mentioned before, the medical device manufacturers based in the EU or EEA and intended to market their products in Northern Ireland would have to appoint a UK Responsible Person by January 1, 2021. The same requirement applies to medical device manufacturers based in third countries, even if they have already appointed an authorized representative in the EU.
The MHRA also describes the exclusion – cases in which the appointment of a UK Responsible Person is not required, namely:
- a medical device manufacturer itself is based in Great Britain,
- a medical device manufacturer itself is based in Northern Ireland,
- a manufacturer already has an authorized representative based in Northern Ireland,
- a medical device in question is a Class I device, custom-made medical device, or general IVD duly registered in the EU.
Summarizing the information provided here above, the present MHRA guidance describes a new regulatory framework for medical devices that will enter into force in Northern Ireland on January 1, 2020. According to the guidance, it would be slightly different from the one applied in Great Britain, hence, the medical device manufacturers would have to take additional steps necessary to achieve and sustain compliance with the new requirements in order to be allowed to market their products in Northern Ireland.
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