CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new EU regulations.
Medical devices and healthcare
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.
Belgian Medical Competent Authority abolishes submission taxes
Belgian medical competent authorities abolish submissions taxes to help ease manufacturers' entry to the European market.
The impact of the new MDR and IVDR Regulations on Notified Bodies
The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to establish a more robust EU legislative framework and ensure better protection of public health and patient safety.
ISO 13485:2016 strengthens the control of suppliers in Medical Device Industry
ISO 13485:2016 aims to harmonise quality system requirements and ensure a higher degree of compliance with regulations amongst suppliers of medical devices.
Transitioning to ISO 9001:2015 & 14001:2015
Understanding new changes under ISO 9001:2008 and ISO 14001:2004 to help navigate the transition for manufacturers.
Clinical Evaluation for medical devices (many more requirements under MDR)
Learn about the changes introduced for clinical evaluations under EU medical device regulation 2017/745. Re-classification, comparative evaluations and more.