Medical Device Directive (MDR)
The European Union has recently put forward a set of rules for medical devices and accessories for such devices. As a start-up in this field you will have to set up a Quality Management System to comply with these rules and to be audited, in order to get your product license and market license. After you receive your license, you will be undergoing yearly audits in which everything gets checked. Not only your company itself, but all other companies you work with as well. The Medical Device Regulation (MDR EU) entered into application on 26 May 2021.
Without a product license you are not allowed to produce, and without a market license you can’t bring your product to the market. The process for receiving these licenses takes at least 3 years, so as a start-up it’s wise to start working on these requirements immediately. Preferably you will have your QMS ready when your product enters the clinical studies phase.
Need help?
Not sure whether your business needs to comply with the MDR? Or could you use some support in establishing your QMS or the Technical Documentation of your devices? At Briskr we can help you with every step in this process. Our experienced supporting partners offer free consults and workshops on this topic. The experts we work with know all ISO, GMP and MDR rules by heart. So whatever questions you have, our network has the answers.
One of our main experts is Anja Wiersma, a medical biologist with 8 years of experience at a multinational pharmaceutical company (Organon) and 6.5 years at a Notified Body of Medical Devices and In Vitro Diagnostic Medical Devices. Since 2010 she is a RA/QA consultant at mi-CE consultancy for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossier reviews and CE audits as well as for executing inspections for independent organisations.
Check our upcoming events to see if there are MDR workshops (presented by Wiersma) you can register for, or contact us if you’re interested in a one-on-one meeting with one of our partners.
