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.
Medical devices and healthcare
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.
Switzerland is aligning the medical devices legislation to the future EU Regulations
Switzerland aligns with EU medical device legislation to make crucial improvements to patient and consumer safety. The country expects to be aligned by 2020.
New Electronical Apostille system from the Belgian Ministry of Foreign affairs
The Belgian Ministry of Foreign Affairs' new electronic apostille system for Free Sales Certificates will have a positive impact on legalization timeframes.
The “sell off” provision under the MDR and IVDR
The EU Competent Authorities for Medical Devices (CAMD) have recently released their FAQs to provide guidance on certain specific aspects concerning MDR/IVDR transition-related provisions.
Read more about it here.