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Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.Continue Reading The EU Medical Device Shake‑Up: What International Companies Should Prepare For

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and European Union.Continue Reading Virtual and Digital Health Digest – December 2025

On 12 December 2025, the European Commission published a draft Implementing Regulation (“the Regulation”) on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies (“NBs”), introducing detailed requirements for NBs operating under the Medical Device Regulations (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (“IVDR”).

The recitals describe serious systemic challenges that have emerged since the implementation of the MDR/IVDR and the proposals aim to set out a structured resolution to these challenges. An overview of these proposals is set out below. Overall, the Regulation aims to create a harmonised NB landscape that is predictable, transparent, and fair – supporting patient safety while easing unnecessary administrative burdens for manufacturers. Whether this goes far enough to address the challenges identified will have to be seen.

The Regulation is open for public consultation until 23 January 2026. Once feedback has been reviewed by the Commission, it will be published. The Commission  anticipates adoption of the Regulations in the first quarter of 2026, following which it will be sent to the European Parliament and Council for consideration. The timing of the formal adoption of the Regulation is not yet clear.Continue Reading A Deep Dive into the EU’s New Implementing Regulation for Notified Bodies

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.

This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission’s  proposal adopted in April 2023, the European Parliament’s position adopted on 10 April 2024, and the Council’s position adopted on 4 June 2025 (see our detailed advisory on the Commission’s proposal and our BioSlice blog posts on the Parliament’s and Council’s positions here and here).

The provisional agreement must now be formally adopted by both the Parliament and the Council.Continue Reading European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2025 from the the United Kingdom, and European Union.Continue Reading Virtual and Digital Health Digest – November 2025

On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]

The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:

(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.

(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant  may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.

(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.

This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).Continue Reading Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?

[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method involving an industrial process and are intended to be placed on the market in the European Union (‘EU’), they are subject to the rules of Directive 2001/83/EC on medicinal products for human use (the ‘Medicines Directive’). In addition, if patients are treated with radiopharmaceuticals, account should be taken of Directive 2013/59/EURATOM (the ‘Euratom Directive’) which lays down basic standards for the protection of individuals against radiation exposure.Continue Reading Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]

On 8 September 2025, the European Commission published a call for evidence on “the targeted revision of the EU rules for medical devices and in vitro diagnostics”. This is part of the Commission’s on-going “targeted evaluation” of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry caused by the regulations.Continue Reading European Commission’s call for evidence on the revision of the MDR/IVDR