EU Commission issued an official notice to cosmetics product manufacturers in run up to Brexit. Key items include labelling, notification, and information file.
Medical devices and healthcare
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.
Spanish Database for Medical Devices and IVD registration changed!
Spain has released a National Registration Process in addition to adopting new EU medical device and IVD regulations and directives.
European Commission has received 33 applications from NBs
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.
Spanish, Croatian and Bulgarian registration of Medical Devices and IVDs
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.
New references of harmonised standards
New references of EU harmonised standards published for personal protective equipment, machinery, ATEX, construction points, pressure equipment, and more.
CAMD and MDR/IVDR transitional provisions
CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new EU regulations.
To What Extent Should You Investigate a Medical Device Complaint?
There are no predefined rules in determining to what extent a manufacturer should investigate a medical device complaint, but there are several key facts and questions that may be used as a guidance. Read on this topic here.