Economic operators or actors, as defined in the Medical Device Regulation (MDR) 2017/745 and In-Vitro Diagnostics medical device Regulation (IVDR) 2017/746 are not required to implement a Quality Management System (QMS) but have procedural requirements to fulfill. Read here what these are.
what is the requirement?
The MDR and IVDR do neither require the implementation of a QMS system nor its certification for distributors. However, article 14 of the MDR and IVDR is clear about the procedural requirements of such actors.
Within the 6 paragraphs of article 4 of both the MDR and IVDR, the regulator lays down the tasks and requirements relevant for distributors to assure, monitor and/or record. These requirements code for the implementation of procedures.
do we need a full-fledged QMS?
Short answer - No!
No doubt, a full-fledged QMS would be too much for a distributor under MDR and/or IVDR. This mainly, as a full QMS would cover the development, industrialization and manufacturing of the medical device. This, however, is not in the responsibility of a distributor.
Covering the requirements is enough?
Just covering the procedural requirements is not enough and will not lead to the compliance of a distributor. How, for example, is training conducted or how are the required processes connected to each other? These questions, as examples, should be addressed as well when aiming for a QMS as a distributor.
Short answer - No!
How Avanti Europe can help
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and contracting to the Pharmaceutical and Medical Device industry. Our experts support your company with a hands-on workforce and support in risk-based process design, documentation, training for the company staff. Visit our online shop for a QMS for distributors, checklists, and other services.