Production and distribution of medical devices
Regulation (EU) 2017/745 of the European Parliament and of the Council and ISO requirements
What requirements does the legislation place on you? Did you know that from 5/2021 you must have a quality system in place? When is ISO 9001 enough and when do you need ISO 13485? How to find your way around it, satisfy it and at the same time manage everything during normal operation?
EU Regulation 2017/745 on medical devices (hereinafter referred to as MDR) with effect from 5/2021 defines requirements for manufacturers and distributors of medical devices. It also stipulates the requirement for the implementation of a functional quality management system.
ISO 13485 is an industry standard defining requirements for medical device manufacturers in the field of production, installation and service. It is much more demanding to implement than ISO 9001. The scope of documentation is almost threefold here!
However, some distributors of medical devices will suffice with the generic standard ISO 9001 supplemented by some relevant articles of the standard ISO 13485. These are distributors who do not repackage traded goods or provide stickers in the CZ language. This approach is easier and much less demanding, yet fully sufficient! We have prepared a combination of ISO 9001 + parts of ISO 13485 for such companies. Make an appointment with us, we will be happy to explain everything to you. The time spent on an interview or meeting will pay you back many times over.
You can find more information in the articles on our blog:
MDR requirements for manufacturers, importers and distributors, responsibilities and transfers in roles
How do the requirements of MDR and ISO 13485 intersect? Do you want to know about it too?
We have prepared for you the MDR / ISO Linkage Matrix , which connects the requirements of the Directive and ISO 13485 and ISO 9001 and facilitates their understanding and application in practice!
Do not hesitate and arrange an online meeting with us, where we will explain more about MDR / ISO Matrix and the requirements of MDR and ISO 13485.
Renata's consultation was fantastic, I already have an excellent analysis from her.
Mgr. Martin Matějček, Head of the Quality Management Department, University Hospital in Motol