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Since leaving the European Union, Great Britain has introduced some changes concerning the placing of medical devices on the UK market. Let’s see here below the main ones.
Until 30 June 2023 the CE mark will continue to be recognised in Great Britain. CE marked devices and certificates issued by EU recognised notified bodies in accordance with applicable legislation (Directive 90/385/EEC, Directive 93/42/EEC, Directive 98/79/EC, Regulation 2017/745 and Regulation 2017/746) will continue to be accepted until 30 June 2023.
From 1 July 2023, the UKCA (UK Conformity Assessed) mark will be required to place a device on the UK market. Products will therefore have to comply with UKCA marking requirements.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the body responsible for regulating medical devices in the UK market. From 1 January 2021, medical devices of all classes and IVDs placed on the UK market must be registered with the MHRA, accordingly with the following timelines:
If a manufacturer is not based in the UK, to place a device on the UK market it must appoint a UK responsible person with a registered office in the UK. This person will assume the manufacturer’s responsibilities for registering the device with the MHRA.
In Great Britain, devices must comply with UK MDR 2002 (implementing the EU AIMDD, MDD and IVDD Directives), MDR 2017/745 (until 30 June 2023), or IVDR 2017/745 (until 30 June 2023) to be registered with the MHRA. Manufacturers must therefore comply with the product marking and conformity assessment requirements of these directives.
However, MDR 2017/745 and IVDR 2017/745 will be fully implemented in EU Member States from May 2021 and 2022 respectively. As these regulations did not come into force during the transition period, their provisions will NOT be automatically implemented and enforced in Great Britain. The UK MDR 2002, on the other hand, will continue to have effect in Great Britain after the transition period.
When conformity assessment by a third party is required, it is necessary to apply to a UK Approved Body. It is the MHRA that designates UK Approved Bodies, that are able to conduct conformity assessments with regard to the requirements for UKCA marking.
Ente Certificazione Macchine is currently preparing to get the necessary accreditations to carry out the conformity assessment procedures required for the issue of the UKCA mark. We are available to provide information and answer questions. It is possible to contact our Sales Manager Antonio Balassone at firstname.lastname@example.org | (+39) 393 2471040
For a more in-depth look at the regulation of medical devices in the UK, see the official UK government guide at this link