Latest regulatory news concerning medical devices and medicines - Feb 2022

There's lots happening in the regulatory world of medical devices and medicines. Here's a reminder of some of the key updates since the start of the year.

UKCA marking / Use of CE markings extended until 2023

In August 2021, the UK government postponed the mandatory introduction of the UKCA marking to replace the EU's CE marking for the Great Britain market. The new deadline for qualifying product types to go through a UK conformity assessment and bear the UKCA marking before being placed on the GB market is 1 January 2023. There are transitional rules in place to allow for the UKCA marking to be affixed to product packaging (i.e. using a sticker) or appear on product documentation until 31 January 2024. From this date, subject to a few exceptions, the UKCA marking will need to be printed on the product itself. Some goods already require the UKCA mark: those that have been manufactured in Great Britain and conformity assessed by a UK approved body. For all others the grace period has been extended to 1 January 2023. This extension is to give manufacturers time to adjust to the introduction of the UKCA marking and to allow conformity assessment capacity in the UK to develop. The guidance for using the UKNI marking was updated on 11 January 2022 to also reflect that from 1 January 2023, products will need to have UKCA marking to be placed on the market in GB for the first time.

 

New EU Clinical Trials Regulation

On 31 January 2022, the EU Clinical Trials Regulation (CTR) will become applicable. The regulation aims to standardise and harmonise the conduct and management of interventional clinical trials across the EU/EEA. This includes the new Clinical Trials Information System (CTIS). CTIS essentially serves as a one-stop, centralised database for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data, which should make authorisation and patient recruitment for multinational clinical trials much easier.

Whilst the CTR is seen as the EU’s opportunity to put Europe back on the map as a world-leading research environment, the UK is keen to keep its position as a global leader in running clinical trials and getting innovations to patients. To that end, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on 17 January 2022 on the future of UK clinical trials legislation.

 

MHRA Public Consultation on UK Clinical Trials Legislation

On 17 January 2022, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on proposals to revise UK clinical trials legislation.

With these proposals, the UK Government outlines a plan to use powers under the Medicines and Medical Devices Act 2021 to update current legislation governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004, which is derived from EU Law. The consultation is open for eight weeks and closes on 14 March 2022.

Overall policy objectives include improving the speed and efficiency of approvals; supporting innovation; enhanced transparency; encouraging greater risk proportionality; and promotion of patient and public involvement. The proposals have been developed by the MHRA and the Health Research Authority (HRA) in collaboration with an expert working group, including patient representation.

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