Medical Devices

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

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

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

The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”).  Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission…

Continue Reading European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device Regulations

In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second…

Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media

Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in…

Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon

The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic.  In the aftermath of the pandemic, there have been repeated calls for more joint procurement.  This blog explores the existing mechanisms for joint procurement and also considers the Commission’s proposal for a Critical Medicines Act (“CMA”) and what it would mean for public procurement.

At a high level, there are already various mechanisms for joint procurement of medicinal products and medical devices both with and without involvement of the Commission.  The CMA proposal does not fundamentally change that but rather supplements the existing regimes.

The key aspect to be aware of is that both the existing regime and the draft CMA merely establish a framework for joint procurement, including the relationship among Member States and the Commission (if involved).  This framework focusses on establishing when joint procurement is possible and the mechanism for getting a joint procurement set up.  However, the framework does not specify in what circumstances Member States and/or the Commission might choose to engage in joint procurement, the terms of the tender or any resulting contract.Continue Reading EU Joint Procurement – An Overview

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.Continue Reading The Covington European Life Sciences Symposium 2025

On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers