Active device (or active medical device) meaning

In this issue: Commercial Competition and state aid Data protection and cybersecurity Financial services Energy Environment IP Life sciences TMT International trade Daily and weekly news alerts New and updated content Trackers and horizon scanners Commercial European Parliament IMCO invites Temu to discuss unsafe and illegal product sales The European Parliament’s Internal Market and Consumer Protection Committee (IMCO) has asked a Temu delegate to join a discussion on 16 April 2026, reflecting intensified scrutiny of leading online marketplaces over the presence of unsafe or illegal goods in the EU. This follows earlier appearances by Shein and AliExpress before IMCO. The committee is also reviewing how the European Commission applies and enforces rules on product safety, consumer protection and digital platforms across the single market. Members have urged more robust action to prevent illegal and unsafe products reaching the EU, including those offered via large online platforms, alongside better co-operation among...

In this issue: Intellectual property Data protection and life sciences Research and development Disputes and regulatory enforcement Medical devices Commercialisation/Pricing, reimbursement and imports Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Intellectual property Article 3(d) entitlement of an uncombined medicinal product (drospirenone) to an SPC (Laboratorios Leon Farma SA v Comptroller) The court had to decide whether the Court of Justice’s ruling in Medeva (Case C-322/10) prevents a supplementary protection certificate where the product was previously authorised only within a combination. It held that it does. Endorsing the IPO’s stance, the court found that an SPC for drospirenone could not be granted: because an earlier marketing authorisation covered drospirenone with oestrogen, the subsequent authorisation for drospirenone alone was not the first MA for that active. This outcome is significant for SPC planning: any prior MA—whether for a monotherapy or a combination—can bar SPC protection for an...

Practice Note Within the EU, medical devices are strictly overseen by legislation that manages safety and performance throughout the whole lifecycle and across the full product lifetime, spanning pre- to post-market stages. This Practice Note outlines the regime established by Directive 93/42/EEC on medical devices (MDD), Directive 90/385/EEC on active implantable medical devices (AIMDD), which applied until 25 May 2021, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which remained in force until 25 May 2022; collectively, the MD Directives. The MD Directives continue to matter for ‘legacy’ devices that were authorised under them for placement on the EEA market before the new rules started to apply. They will also persist as points of reference for several years for particular legacy devices, for differing durations, pursuant to transitional provisions. This Practice Note sets out how devices were categorised, subjected to conformity assessment, and affixed with the CE mark under the MD Directives. It further addresses advertising and promotion of medical devices, the issue of counterfeit medical devices,...

This Practice Note introduces supplementary protection certificates (SPCs) and paediatric extensions (PEs) in the UK. It outlines the reasons for their creation, when and how to apply, and how long they run. It also reviews leading rulings on SPCs from the courts of England and Wales, together with UK Intellectual Property Office (IPO) guidance on SPC procedure... It further surveys numerous references to the Court of Justice on the interpretation of Regulation (EC) 469/2009 and Regulation (EC) 1610/96, which regulate SPCs for medicinal products and plant protection products within the EU (and, before Brexit, in the UK). The resulting Court of Justice decisions have defined the scope of SPC protection across the EU and the UK. For guidance on whether Court of Justice rulings bind UK courts, see Practice Note: Assimilated law—Assimilated case law. For a discussion confined to the EU SPC regime, see Practice Note: Supplementary protection certificates and paediatric extensions—EU... Supplementary protection certificates (SPCs) What is an SPC? An SPC prolongs the protection provided...

This Practice Note offers guidance on the EU regulatory landscape and the developing UK framework for vapour products and e‑cigarettes in the wake of Brexit and after IP completion day (eg 31 December 2020, the close of the Brexit implementation period). What are vapour products? Under EU and UK law, vapour products (often referred to as ‘e‑cigarettes’ or ‘e‑cigs’, ‘vapourisers’ or ‘vapes’) are characterised as products that can generate an inhalable aerosol containing an active ingredient, typically nicotine or a cannabinoid (CBD), through a mouth piece. Vapour products function by heating a solution (e‑liquid) that generally contains nicotine, propylene glycol and/or vegetable glycerine, flavourings, and the active ingredient (eg nicotine, CBD). E‑cigarettes do not contain tobacco (ie leaves and other natural processed or unprocessed parts of tobacco plants), and do not burn or produce the products of combustion associated with smoking, including carbon monoxide and ‘tar’. They are separate from both ‘tobacco products’ and ‘herbal products for smoking’ (which are products based on plants, herbs or fruits which...