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.
Authorities in the Netherlands classify the printing of misleading claims on labelling or instructions for use on cosmetics products a criminal offence.
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.
European Commission publishes updated version (V1.20) of the Borderline and Classification Manual for medical and in-vitro diagnostics devices on the EU market.
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.
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.
Obelis announce new Obelis UK Ltd to provide services for cosmetics manufacturers requiring a UK Responsible Person in the case of a 'no deal' Brexit.
How much does CE Marking and Certification cost? Find out more about this topic here.
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.
Since the introduction of EU Medical Device Regulation 2017/745, manufacturers have been rushing to prepare for it taking full effect on 25th May 2020. The best advice is to start getting ready for the transition now to ensure a smooth process with no negative effects. The first step in getting ready for MDR 2017/745 is understanding what it is and what requirements it has for manufacturers of medical devices. With that in mind, we put some information together to help clear the process up!