Obelis' CE marking experts walk you through the simple 7-step process for obtaining a CE marking for medical devices and accessing the European market.
Medical devices and healthcare auto
Commission’s communication campaign on MDR and IVDR – special notice to manufacturers
European Commission issues special notice to medical and in-vitro diagnostic device manufacturers to clarify scope and requirements of new EU regulations.
ECHA publishes new report on nanomaterials in the European Union
European Chemicals Agency releases a report on truthfulness of data on nanomaterials in EU cosmetics products. Download the report for free in English.
Incidents defined under the new Medical Device Regulation
Learn more about the definition and categorization of incidents as outlined by new EU medical device regulation 2017/745.
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.
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.
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.
New MDR Conformity Assessment Routes
The approaching EU Medical Device Regulation – which will become applicable on 26 May 2020 – puts great emphasis on the assessment of product safety and performance by placing stricter requirements on clinical evaluation, post-market clinical follow-up and traceability of devices. Thus, the manufacturers worldwide need to perform some crucial adjustments in order to become compliant with the new law.