Spain has released a National Registration Process in addition to adopting new EU medical device and IVD regulations and directives.
Medical devices and healthcare auto
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.
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.
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.
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.