EU MDR standards The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR standards and reference requirements can be used for that purpose. The manufacturer may benefit…
Medical Device Classification in the EU MDR One of the first concerns for manufacturers of medical devices attempting to sell their products on the European market is to decide what class is suitable for their products. The Medical Device classification in the EU MDR of the product can affect how and when the notified body…
EU MDR – Guide overview Below is a summary of different activities pertaining to the EU MDR (Europe Medical Device Regulation 2017/745). Compliance with EU MDR requirements is mandatory since May 26, 2021. Our summary includes the following sections: Summary of obligations from the manufacturer Summary of obligations of the manufacturer concerning his devices before…
Medical Device Regulation date of application postponed The European medical device regulation 2017/745 have been postponed one year later in order to avoid shortages in getting key products available on the market during the coronavirus pandemic. The Medical Devices Regulation (MDR) which was initially enforceable on 26 May 2020 will now become fully effective on…
In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage. The document itself can be found here. We’ll highlight below the changes that occured in the new guidance.