Header graphic for print
Focus on Regulation

Tag Archives: Medical Devices Directive

The European Commission has published Guidelines concerning the use of phthalates in medical devices

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices. The Guidelines concern the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic and toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. The

The European Commission releases an updated Borderline Manual for medical devices

Introduction The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).

The European Medicines Agency issues an opinion on the principal mode of action of proanthocyanidins present in cranberry extracts

On 8 November 2016, the European Commission published the opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) concerning the principal mode of action of proanthocyanidins present in cranberry extracts and included in products intended to be used by their manufacturers for prevention and treatment of urinary tract infections.

EUROPEAN COMMISSION REVISES BLUE GUIDE ON THE IMPLEMENTATION OF EU PRODUCT RULES

The European Commission has published a revised Blue Guide on the implementation of European Union product rules (“Blue Guide”).  The Blue Guide aims to facilitate an improved understanding of the European Union (“EU”) legal framework for the placing of various products on the EU market and to ensure its uniform and coherent application across the

European Parliament plenary vote on revised medical devices package

On 22 October 2013, the European Parliament voted, during a plenary session, on two draft Regulations intended to replace the current Medical Devices Directive[1], the Active Implantable Medical Devices Directive[2], and the In Vitro Diagnostic Medical Devices Directive[3]. The draft Regulations[4] will now be discussed by the Council of the European Union (“Council”) which is