draft UK law

Subscribe to draft UK law via RSS

On 11 May 2026, the Medicines and Healthcare products Regulatory Agency (“MHRA”) opened a call for evidence on proposed changes to pre-market medical device and in vitro diagnostic medical device (“IVD”) requirements in Great Britain (“GB”) under the Medical Device Regulations 2002 (“2002 Regulations”). The proposals are set out in the newly published draft Medical Devices (Amendment) Regulations 2026 (“Amending Regulations”). This call for evidence forms a critical part of the UK government’s process for assessing the real‑world implications of a major reform of GB’s medical devices regulatory framework.

These long awaited proposals, as referred to in the MHRA Roadmap published in December 2024, follow previous amendments made to the 2002 Regulations in June 2025, relating to post-market surveillance. Read about these amendments in our previous blog.

Below, we explain what the call for evidence is, why it matters, and provide an overview of some of the key regulatory proposals that stakeholders are being asked to comment on.

Continue Reading Draft UK Medical Device Amending Regulations: Key Proposals and MHRA Call for Evidence

Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.

The agenda includes a Product Safety and Metrology Bill.  Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI.  We set out below a brief summary of the Bill.

Continue Reading The King’s Speech: Product Safety and Metrology Bill

On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit.

What is exhaustion?

As summarised in the explanatory memorandum, the exhaustion rule prevents the holder of an intellectual property right from using that right to stop the importation of a product into an EU country where it has been lawfully placed on the market in another country in the European Economic Area (EEA). In other words, an IP holder cannot use its IP rights to prevent parallel import (sometimes called grey imports) of goods from within the EEA. Unless the law is changed, this will not apply after Brexit, because the UK will no longer be part of the EEA. The proposed legislation seeks to change this so that exhaustion still applies to any goods brought into the UK, provided they have been placed on an EEA market with the IP owner’s consent. This will apply irrespective of whether there is a Brexit deal or not, and it is intended that this comes into effect on Brexit-day, if approved by Parliament.Continue Reading Brexhaustion: IP Rights and Exhaustion Post-Brexit