Medical devices

Medical devices

Medical devices

Until the application of a new regulatory framework for the EU beginning from 26 May 2021, the regulatory framework in the EU for medical devices, active implantable medical devices (AIMDs), and in vitro diagnostic medical devices (IVDs) consisted of:

•
Directive 93/42/EEC on medical devices
•
Directive 90/385/EEC on active implantable medical devices
•
Directive 98/79/EC on in vitro diagnostic medical devices

These MD Directives remain relevant to ‘legacy’ devices and those that were placed on the market before applicable deadlines for certain devices to transition to the new EU regulations. However, all devices must comply with certain increased obligations of compliance under the new EU medical devices regulatory regime. See Practice Note: An introduction to the regulation of medical devices—EU Directives regime.

In the UK, the MD Directives have been implemented via the Medical Devices Regulations 2002 (MDR 2002), SI 2002/618, which were issued under the Consumer Protection Act 1987. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK competent authority responsible for supervision of medical device regulation. The end of the Brexit transition period

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest Life Sciences News

Life Sciences weekly highlights—26 February 2026

This week's edition of Life Sciences weekly highlights includes a Law 360 analysis on the Court of Appeal dismissing Salts Healthcare Ltd’s renewed attempts to find Pelican Healthcare Ltd liable for infringing one of its patents over an ostomy bag and an analysis by Hepworth Browne of the UK Supreme Court’s ruling in Emotional Perception AI Ltd v Comptroller-General of Patents, in which the court reshaped the foundations of UK patent law by reorientating the assessment of exclusions to patentability. Also included, is news that the Court of Appeal dismissed the appeals in a biotechnology patent dispute regarding the production of microbial oil for nutritional products, the EU General Court issued orders in challenges concerning the revised Urban Wastewater Treatment Directive (UWWTD) on the grounds of admissibility, not addressing the substantive question of the legality of the Extended Producer Responsibility (EPR) scheme, the MHRA and NICE have jointly published guidance on the Integrated Scientific Advice service, EFPIA published a report assessing the economic and societal contribution of industry-sponsored clinical trials in Europe as well as a comparative analysis of biopharmaceutical strategies across ten countries, and news that the UK Research and Innovation announced its first AI strategy, the Department for Science, Innovation and Technology (DSIT) announced £150m for three UK Research and Innovation programmes, as well as MHRA updates reporting a rise in clinical investigations, the launch of a fee waiver pilot for small firms, a statement on the paused PATHWAYS clinical trial, and enforcement action involving the seizure of unlicensed weight loss medicines, among other stories.

EFPIA and Medicines for Europe call for suspension of UWWTD EPR scheme implementation

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe and other organisations representing the cosmetics and pharmaceutical sectors have urged EU Ministers of Economy to ask the European Commission to ‘stop the clock’ on implementing the extended producer responsibility (EPR) scheme under Directive (EU) 2024/3019 (Urban Wastewater Treatment Directive, UWWTD). They state that the cost of upgrading wastewater treatment to remove micropollutants may be significantly higher than the Commission’s estimate of up to up to €1.4bn annually until 2045. They also raise concerns that the methodology used to allocate toxic load to sectors overstated the contribution of pharmaceuticals and cosmetics to urban wastewater pollution. They argue that limiting EPR obligations to those sectors is inconsistent with the polluter pays principle. In addition, they indicate that the directive could result in increased financial and administrative burdens, particularly for small and medium-sized enterprises, and note that fixed pricing mechanisms in the pharmaceutical sector may limit the ability to pass on additional compliance costs, with potential implications for medicine supply. They call for a pause in the EPR-related provisions and for a further science-based reassessment of the directive’s impact.

Commission adopts recommendation on diagnostic reference levels for medical radiation procedures

The European Commission has adopted Recommendation (Euratom/2026/403) on the establishment, review and use of diagnostic reference levels for radiodiagnostic examinations and interventional radiology procedures. Building on Directive 2013/59/Euratom (the Euratom Basic Safety Standards Directive), the recommendation sets out methodologies and good practices for establishing, maintaining and periodically reviewing national diagnostic reference level systems for the medical use of ionising radiation. The measure forms part of the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) Action Plan, an EU initiative aimed at ensuring the safe, high quality and reliable use of radiological and nuclear technology in healthcare.

MHRA raids two premises seizing unlicensed weight loss medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has conducted raids on two premises in Lincolnshire and Nottinghamshire as part of an ongoing investigation into an organised criminal network involved in manufacturing unlicensed weight loss medicines. The Criminal Enforcement Unit (CEU), supported by Lincolnshire Police, Immigration Enforcement and Lincolnshire Trading Standards, seized almost 2,000 doses of unauthorised weight loss medicines awaiting dispatch to customers, alongside manufacturing equipment, suspected pharmaceutical ingredients, packaging and commercial vehicles. The premises searched comprised a farm near Sleaford and a residential address in Grantham, believed to have been used for manufacturing and distributing unlicensed weight loss medicines including retatrutide and tirzepatide, as well as peptide products. The operation follows a previous raid in October 2025 in which CEU officers dismantled what the MHRA described as the UK's first illicit weight loss medicine manufacturing facility in Northampton.