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:

  1. Directive 93/42/EEC on medical devices

  2. Directive 90/385/EEC on active implantable medical devices

  3. 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

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Latest Life Sciences News

Life Sciences weekly highlights—14 August 2025

This week's edition of Life Sciences weekly highlights includes an analysis by Freshfields LLP on the UK Law Commission’s review of the product liability regime, with a focus on AI technologies and recent EU developments, an analysis by Pinsent Masons of the High Court’s ruling in Samsung Bioepis v Alexion, which invalidated Alexion’s eculizumab patent and found no infringement, underscoring the importance of precise drafting in biologic patents and a Law360 story on the Court of Appeal’s ruling in a long-running patent infringement dispute between coronavirus (COVID-19) vaccine developers, upholding Moderna’s mRNA patent against Pfizer/BioNTech. Also included is news that the MHRA has been designated as a WHO-Listed Authority, launched a consultation seeking UK stakeholder feedback on the revised ICH M4Q(R2) and announced that UK licence holders must now independently monitor US FDA Warning Letters, the EMA updated its guidance on paediatric submissions, as well as news that the European Commission published a study on legal and regulatory challenges to AI deployment in healthcare across the EU, the MHRA launched a stakeholder survey on the health institution exemption for medical devices and updated guidance on adverse event reporting requirements for digital mental health technologies, following the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, and the DHSC dispute resolution panel ruled that Haleon must remain in the voluntary branded medicines pricing scheme (VPAG) for 2024, despite its claim of administrative error in joining, among other stories.

When sequence precision backfires—Invalidity and non-infringement of Eculizumab Patent with 22-Amino Acid Leader (Samsung v Alexion)

IP analysis: The High Court held that Alexion’s patent for eculizumab, which claimed a light chain sequence including a 22-amino acid leader, was invalid and not infringed by biosimilars from Samsung Bioepis and Amgen. Although the biosimilars matched the therapeutic sequence of eculizumab, they lacked the leader sequence specified in the patent. Central to the dispute was whether the claimed sequence covered the clinically used eculizumab, which lacks the leader sequence. The court rejected Alexion’s purposive construction, and the claimants conceded the patent should be revoked on that basis. Even if infringement had been found, the patent would have failed for obviousness. The case underscores the importance of precise sequence drafting in biologic patents, especially where production processes remove non-functional regions. It shows the risks of relying on broad claim constructions that diverge from the literal sequence disclosed and used in practice. The multi-jurisdictional nature of these proceedings (including before the UPC) served to highlight deficiencies in Alexion’s case, where inconsistent arguments across different fora impacted on credibility. While decisions of other courts, including the UPC, should be brought before the UK court, they will not be material to the judge’s decision making. Written by Jennifer McDowall, associate at Pinsent Masons.

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