European Commission publishes updated version (V1.20) of the Borderline and Classification Manual for medical and in-vitro diagnostics devices on the EU market.
Medical devices and healthcare auto
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.
Game Plan for Upgrading Compliance under Medical Device Regulation 2017/745
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!
New updates on the state-of-the art thinking on UDI system and database.
Learn more about the new European Unique Device Identifier (UDI) classification system and database introduced under EU Medical Device Regulation 2017/745/EC.
Critical ALERT (!) – EU Official Notice on BREXIT
EU Commission issued an official notice to cosmetics product manufacturers in run up to Brexit. Key items include labelling, notification, and information file.
New version of EN ISO 10993-1:2008
Learn more about the new ISO standards set for evaluating the biocompatibility of medical devices on the European market.
PVCs in medical devices
PVC materials are nowadays widely used in many applications like containers or tubing, due to its easy and cheap production, flexibility, versatility with different shapes and designs, chemical withstanding and hygienic properties. Read more about it.
The Medical Device Coordination Group gives guidance on the UDI database for the particular cases of Systems and Procedure Packs and Medical Device Software.
The Medical Device Coordination Group for the EU has issued guidance on using the UDI database for medical device software and systems and procedure packs.