The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a targeted consultation on the indefinite recognition of the CE-mark for medical devices placed on the market in Great Britain (“GB”) (i.e., England, Scotland and Wales) (the “Consultation”), which will run until 10 April 2026.  The Consultation aims to complement wider planned reforms to the UK medical device regulatory framework that are expected to be announced later this year.  The Consultation applies to GB only as medical devices placed on the Northern Ireland market must comply with the EU medical devices framework and be CE-marked in any event.

The Consultation follows an earlier public consultation on pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (see our prior blog post here), where the MHRA announced its intention to further consult on the indefinite recognition of CE-marked medical devices in GB.Continue Reading UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical Devices

In short

On February 5, 2026, the European Court of Justice (ECJ) dismissed the European Commission’s appeal in Case C-540/23 P, confirming the Judgment of the General Court in Case T-201/21, Covington & Burling and Van Vooren v Commission.

The Court confirmed that Member States’ votes when adopting administrative…

Continue Reading EU Court Confirms No Presumption of Confidentiality for Member State Votes: Covington Prevails in Case C‑540/23 P

Introduction

As discussed in our previous blogpost (link), on 16 December 2025, the European Commission (“Commission”) released its Proposal for the European Biotech Act (“Biotech Act”) (see here). 

This blogpost focuses on Chapter II of the Proposal (“Union Health Biotechnology and Biomanufacturing”), which introduces a framework for the recognition of “health biotechnology strategic projects” (“Strategic Projects”) and “high impact health biotechnology strategic projects” (“High Impact Strategic Projects”), together with a package of regulatory and support measures aimed at accelerating their development and deployment in the Union.Continue Reading The Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology Sector

Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly…

Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work

Germany has kicked off a new Pharma and MedTech Dialogue that aims to develop new policies and regulatory reform proposals to re‑establish Germany as a competitive, innovation‑friendly location for life sciences R&D and manufacturing. The outcome of this dialogue shall be the basis for a new German Pharma and MedTech…

Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects

On November 5, 2025, the Spanish Ministry for Ecological Transition and Demographic Challenge (“MITECO”) adopted a Resolution setting out the National Plan for the control of compliance with access and benefit-sharing (“ABS”) obligations under Regulation 511/2014 implementing the Nagoya Protocol in the European Union.  The National Plan sets out a…

Continue Reading ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules
  • First, the guidance confirms that the authorities will treat CCPs produced using animal cells as products of animal origin.  Producers of CCPs from animal cells must therefore
… Continue Reading UK Launches Food Safety Guidance for Cell-Cultivated Foods

Introduction

On 16 December 2025, the European Commission (“Commission”) published its Proposal for a Regulation on establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors particularly in the area of health (“Biotech Act”) (see here).  The Proposal follows a public consultation held between…

Continue Reading European Commission Adopts Proposal for the Biotech Act

This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.

On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech…

Continue Reading European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicines

This is one in a series of Inside European Life Sciences blogs on the proposal for an EU Biotech Act in the form of a regulation that the European Commission released on 16 December 2025.  This blog focuses on the proposals to amend the EU’s clinical trial rules and establish…

Continue Reading The Proposed EU Biotech Act Aims to Accelerate and Streamline Procedures for the Approval of Clinical Trials and Combined Studies