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!
Learn more about the new European Unique Device Identifier (UDI) classification system and database introduced under EU Medical Device Regulation 2017/745/EC.
EU Commission issued an official notice to cosmetics product manufacturers in run up to Brexit. Key items include labelling, notification, and information file.
Learn more about the new ISO standards set for evaluating the biocompatibility of medical devices on the European market.
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 for the EU has issued guidance on using the UDI database for medical device software and systems and procedure packs.
Spain has released a National Registration Process in addition to adopting new EU medical device and IVD regulations and directives.
Team-NB published figures on the intentions of 33 of their members to apply as designated notified bodies under new EU MDR and IVDR regulations.
It is well known that the Medical Devices 93/42/EEC and the IVD 98/79/EEC Directives are leaving space to National Competent Authorities regarding the application of the Laws, and also the eventual imposition of additional requirements when possible. Obelis can provide assistance for Spain, Croatia and Bulgaria, in addition to Italy, France, Greece, Portugal and Latvia.