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 EU harmonised standards published for personal protective equipment, machinery, ATEX, construction points, pressure equipment, and more.
CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new 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 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 authorities abolish submissions taxes to help ease manufacturers' entry to the European market.
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.
Learn about the changes introduced for clinical evaluations under EU medical device regulation 2017/745. Re-classification, comparative evaluations and more.
SASO CoC (Certificate of Conformity) and CAP (Conformity Assessment Program) are two particular Conformity Assessment routes that are allowing manufacturers worldwide to enter the market of Saudi Arabia with their products. This is in order to ensure some key objectives such as: Protection of public health, Consumer safety, National security, Protection of religious and public morals and environment, Prevention of deceptive practices.
How can a manufacturer decide on the classification of their electronic cigarettes?
Find out how E-cigarettes need to be regulated in the EU Market.