CE marking related to the registration medical devices in Europe.

EU MDR standards

EU MDR standards

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…

EU MDR

MDR EU

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…

MEDDEV 2.7.1

MEDDEV 2.7.1

MEDDEV 2.7.1: clinical evaluation New Regulation on Clinical Evaluation One of the changes of the Medical Device Regulation by the European Commission is the compliance with clinical evaluation. This means that a report with an expert opinion of medical professionals about the quality and safety of the medical device will not be sufficient any longer.…

EU medical Device Regulation

EU Medical Device Regulation changes

What happened before the EU Medical Device Regulation and In vitro Diagnostic Regulation ? See what changes in EU medical Device Regulation. The existing European regulatory framework originated in the 1990s consists of three directives designed to regulate about 500,000 types of medical devices (e.g. contact lenses, breast implants, x-ray machines, pacemakers) and in-vitro diagnostic…