Learn more about the definition and categorization of incidents as outlined by new EU medical device regulation 2017/745.
News
MHRA Official Guidance on How Medicines, Medical Devices and Clinical Trials Would Be Regulated If There’s No Brexit Deal
March 29th 2019 is fast approaching, and the UK is currently facing to leave the EU without a deal in place. For this reason, the UK government has been publishing technical notices for businesses and citizens to understand what to expect in a no deal scenario. We will focus on the recently published MHRA official guidance with regard to the regulation of medicines, medical devices and clinical trials in case there is no Brexit deal. Find here the most remarkable points.
The prohibition of misleading claims arising from Article 7 MDR was implemented as a criminal offence in the Netherlands
Authorities in the Netherlands classify the printing of misleading claims on labelling or instructions for use on cosmetics products a criminal offence.
Chemicals Found To Be Non-Compliant with EU Rules
German Federal Institute for Risk Assessment found 32% of ECHA-authorised substances to be non-compliant with EU Cosmetic Regulation 1223/2009.
“Equivalence” under the New EU MDR
Read more on how new EU Medical Device Regulation 2017/745 defines the term “equivalence” and what implications it has for products already on the EU market.
NEW VERSION OF THE BORDERLINE AND CLASSIFICATION MANUAL FOR THE MEDICAL DEVICES AND IVDs
European Commission publishes updated version (V1.20) of the Borderline and Classification Manual for medical and in-vitro diagnostics devices on the EU market.
New updates on the Poison Centres website
The Poison Centres website has been updated with new support pages in order to assist the industry to prepare and submit information on hazardous mixtures.
GPSD – steps to compliance
Learn more about the steps to compliance for your product under European General Product Safety Directive 2001/95/EC, from CE certification to the RAPEX system.
ECHA: EU investigates permanent cosmetics and tattoo inks
The ECHA has been conducting studies into harmonizing EU tattoo and permanent make-up safety processes and legislation across Europe.
Registration of medical devices in Slovakia
Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 28 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation. An example of such local implementation of the Directive is now present in Slovakia. Read more here.