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.
Medical devices and healthcare
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.
Potential Impact of Brexit over Authorized Representatives
The UK has officially started the withdrawal procedure of their EU Membership by delivering the formal letter invoking Article 50 TEU on the 29th of March 2017. Complex negotiations will follow with a tight deadline of two years to settle various regulatory issues. What are the possible consequences involved for the European Authorized Representatives (EAR) ?
Read more about it.
Belgian Medical Competent Authority abolishes submission taxes
Belgian medical competent authorities abolish submissions taxes to help ease manufacturers' entry to the European market.