New Guidance for Medical Devices Accessing United Kingdom
The United Kingdom left the European Union on January 31, 2020 (so-called Brexit). However, the UK continues to take part in the EU Customs Union and the Single Market up to December 31, 2020. Starting from January 1, 2021, significant changes are going to happen in legislation of Great Britain. This will lead to changes in the access procedure for many categories of products entering the market of the UK.
Thus, for medical devices on the UK market the responsibility will be taken on the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers who want to place a device on the UK market will first need to register with the MHRA. Please, note that if the manufacturer is not a resident of the UK he will need the local representative there.
The MHRA gives a grace period for different categories of products to prepare for the new registration requirements.
The following categories of products must be registered in the MHRA until April 30, 2021:
Active implantable medical devices
Class III medical devices
Class IIb implantable medical devices
IVD List A
The following categories of products must be registered in the MHRA until August 31, 2021:
Class IIb non-implantable medical devices
Class IIa medical devices
IVD List B
The following categories of products must be registered in the MHRA until 31 December 2021:
Class I medical devices
Apart from the new regulatory body, the conformity assessment procedure will also be changed. Currently, devices are regulated under:
Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
After the transition period, the devices must meet the requirements of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). In fact, this UK Regulations consists of the provisions from the EU Directives. That is why the UK conformity bodies that are accredited under the EU directive will continue their work but under the Medical Devices Regulations 2002. And as a consequence of this, products accessed by the UK conformity body will should have the UK Conformity Assessed mark (UKSA mark). The UKCA mark will not be recognized in the EU, EEA (European Economic Area) or Northern Ireland markets, so to sell products on the above-mentioned markets, a CE mark will still be required.
Please, note that the UKSA mark will be recognized in Great Britain from January 1, 2021. However, The MHRA will continue to recognize the CE mark for devices until June 30, 2023.
It means that certificates issued by EEA-based Notified Bodies will continue to be valid for the Great Britain market until June 30, 2023.
Please note that the certification that is conducted by an EEA-based Notified Body will be recognized on the Great Britain market as well as on the EU markets. The only thing you need to have is an EU, EEA or Northern Ireland authorized representative to sell products on these markets respectively.
if the device has a valid CE certificate or declaration of conformity it will be recognized on the UK market up to June 30, 2023.
From January 1, 2021, medical devices placed on the UK market will need to have either the UKCA mark or a CE mark depending on the legislation the device has been certified under. There is no need to put the UKSA mark if the product is certified under EU regulations until June 30, 2023.
Even though the UKCA mark will need to be used in the UK from July 1, 2023, a CE mark will still be needed for devices placed on the Northern Ireland market as well as confirmation of their compliance to the EU rules.
A UK Approved Body can assess the devices for the Northern Ireland market. But in this case, the UK(NI) mark and not CE mark should accompany the product.
For the Northern Ireland market, the UKSA market devices are not accepted. It is allowed to put on the Northern Ireland market device that is accompanied by the CE or UK(NI) mark only.
The full text of the Medical Devices Regulations you can find here.
The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.
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