Publications

Publications

Digital Health: CE marking of medical devices

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of ...

Hogan Lovells Publications

The EU regulatory challenges and liability risks associated with 3-D printed medical devices

In this hoganlovells.com Q&A, Hogan Lovells counsel Fabien Roy addresses EU regulations that apply to medical devices that are produced using 3-D printing technologies.

Blog Post

Excessive pricing in pharmaceutical products attracts the European Commission’s attention

In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last...

Blog Post

The MHRA issues new guidance concerning own brand labelling or "virtual manufacturing"

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical ...

Blog Post

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are out

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”)...

Blog Post

New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public...

Blog Post

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716 implementing the French Law 2016-41 modernising the French healthcare system (“French Law 2016-41”) was adopted. This Decree...

Hogan Lovells Publications

International Product Liability Review – Issue 64

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety.

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