The medical device sector is one of the most highly regulated market sectors in the world and the European Union Medical Device Regulation is one of the most strict with the broadest scope. Let’s see what the latest regulation is about and how it affects you.
The European Union Medical Device Regulation (EU) 2017/745 (EU MDR) entered into application on 26 May 2021 so if you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices you must comply with this regulation.
EU MDR and Manufacturers
Under the MDR manufacturers have the largest number of responsibilities because both the medical device and the manufacturer are subject to comply.
The EU MDR governs everything from the device conception and design through manufacture, marketing and surveillance post-release.
Because this new regulation scope is broader, many manufacturers are facing this compliance process for the first time while others will have to implement several changes to their previous processes.
In summary, the Article 10 MDR requires that all manufacturers must:
Follow design and medical devices manufacturing guidelines in accordance with MDR
Have a Risk Management system in accordance with Annex I Section 3 of the MDR
Conduct an appropriate Clinical Evaluation of all their devices
Maintain a record of up to date technical documentation
Have access to a Person Responsible for Regulatory Compliance (PRRC)
Implement a Quality Management System (QMS)
Once MDR compliance has been achieved and assessed by a Notified Body, manufacturers must mark their devices with a CE-mark and follow a Unique Device Identification (UDI) system.
Medical device manufacturers also have to ensure the production keeps going in compliance and declare any changes to the authorities.
Simplifying the challenges of EU MDR
MDR software solutions like EudaMed Connect provide the ability to scan incoming serialised Medical Devices that include a UDI and provide additional device information when connected to the EU EudaMed database.