Currently all new medical devices planned to be sold in European Union faces a huge challenge in the Conformity Assessment procedure to obtain the CE mark for Market Access. Medical Device Regulation is in force for all new products, introducing a high level of burden, which calls for action for the manufacturers starting from the first step of the design, requesting continuous effort until the product reaches the market, and even after that.
Medical Device Regulation was issued in 2017, and after one year postponement, became fully applicable on 26 May 2021, causing an incredible high burden to the manufacturers who want to put the product to the EU market as well.
After 2 years since the application date, there are many bottlenecks in the procedure which are very important to know in advance in order to save time and money and unnecessary hassle for the manufacturers.
The speaker would present the most important challenges faced by the manufacturers, using his 17 years of experience as a Lead auditor and Certifier at one of the major Notified Body in Europe, as well as the last 4 years spent at a leading CRO in Central Europe.
Knowing these challenges would give for the manufacturers a huge advantage on the Regulatory Pathway when going to obtain the CE mark for the European Market