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News on EU Pharmaceutical and Medical Devices Laws

1. New pharmaceutical legislation

With the so-called Pharmaceutical Strategy, the EU Commission in parts fundamentally amends the legislation on pharmaceuticals for use in humans.

Drafts have been leaked during the past few weeks, though the EU Commission plans to present its proposals mid-March.

Whilst there a no official documents pertaining to the new EU Directive and Regulation in the context of the EU Commission’s Pharmaceutical Strategy, there has already been much ado about the leaked documents.

The placing of medicinal products on the market is subject to a harmonised regime through Directive 2001/83/EC and Regulation 726/2004, the cornerstones of EU pharmaceutical law.


Directive 2001/83/EC contains the basic principles and rules generally applicable to all medicinal products, from the key requirement to hold a prior marketing authorisation to manufacturing, safety and trade control, distribution, distant sales, labelling, pharmacovigilance and advertising.

Regulation 726/2004 sets up the centralised authorisation procedure and the European Medicines Agency (EMA).

Under the Pharmaceutical Strategy, which has been discussed on this Blog before, adopted on 25 November 2020, the Commission aims at a future proof regulatory framework, addressing some of the challenges the industry faces and allegedly promoting research and technologies.

Cornerstones are legislative measures, i.e. the Directive and Regulation currently under discussion and non-legislative action, in particular

We will report on the official proposals.

2. Extensions regarding transitional periods pertaining to Medical Device Regulation and In-Vitro Diagnostics Regulation

The Council of the European Union yesterday, March 7, 2023, voted in favor of the European Commission’s proposal to amend the transitional provisions for certain medical devices under the MDR/IVDR. Whilst the amendment will not introduce substantive revisions to the quality, safety, and performance provisions set forth in the MDR and the IVDR, it will give medical device manufacturers additional time to bring their devices into conformity with the requirements in those Regulations.

What does this mean?

There will be

Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.

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Dr. Gisela Grabow


Lawyer (England/Wales)