On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and...more
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 Health....more
5/8/2018
/ Belgium ,
Data Protection ,
Disclosure Requirements ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Personal Data ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Standards ,
Sunshine Act
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by...more
The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”) has...more
The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared...more
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....more
The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more
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 week, the European Commission issued a...more
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 devices in the United Kingdom. The Guidance,...more
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”) and the In Vitro Diagnostics Regulation (“IVDR”)....more
On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more