UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
With regard to medical devices, a UK Conformity Assessed (UKCA) mark is valid indefinitely, and the underlying conformity assessment does not require renewal unless the specifications of the device change. The MHRA has the power to issue various notic- es to manufacturers (eg, prohibition notices) to ban the supply of any goods that are considered unsafe or that do not comply with the UK Medi- cal Devices Regulations. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and An application for a UK national MA must be made to the MHRA and must include the par- ticulars and research data or justifications for exceptions that are described in the HMRs, which is based on the EU Directive 2001/83. Following Brexit, UK MAs were split into various types, depending on the parts of the UK to which they apply. In particular, applications intended to cover the marketing of a product in Northern Ire- land had to comply with the requirements of EU Directive 2001/83 and EU Regulation 726/2004. This led to different types of authorisation in dif- ferent parts of the UK. However, under the Wind- sor Framework, from January 2025, applications for a UK-wide product licence can be made to the MHRA under UK law. Medical Devices As of 1 January 2021, there is a new route to place a device on the Great Britain market, with an accompanying mark based on the require- ments derived from the Medical Device Direc- tives as implemented into UK law: the UKCA. EU CE marking (the acronym for the French Con- formité Européenne or “European conformity” ) will continue to be recognised in Great Britain, Medical Devices Medicinal Products
and certificates issued by EU-recognised Noti- fied Bodies will continue to be valid for the Great Britain market, up to June 2030, with different dates depending on the device. EU rules will continue to apply in Northern Ire- land, and EU CE marking is required. In addition, if the manufacturer chooses to use a UK Noti- fied Body for mandatory third-party conformity assessment for purposes of the Northern Ireland market, the UKNI mark must be applied in addi- tion to the CE mark. As previously noted, medical devices are given a classification depending on the level of risk associated with their use. Each risk classifica- tion also has a separate conformity assessment procedure. If the relevant requirements are met, the Approved Body will issue a UKCA certifi- cate. Only UK-Approved Bodies may conduct conformity assessments in relation to a UKCA mark. They are not able to issue CE certificates other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland. Low-risk Class I medical devices do not need to go through a conformity assessment procedure. For all devices, once the relevant assessment has been completed successfully, the manufac- turer may place a UKCA mark on their medical device and put it on the market in Great Britain. To be placed on the Great Britain or Northern Ireland market, all devices must now be regis- tered with the MHRA, which will only accept the registration of devices from entities based in the UK. Therefore, manufacturers based outside the UK are required to appoint a UK Responsible Person that is established in the UK.
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