EU MDR – What is it and why is it necessary?
Author: Dorothy Wilkerson – Regulatory Affairs Manager
The new European Union Medical Device Regulation (EU MDR (EU) No. 2017/745) and In Vitro Diagnostic Regulation (IVDR) present the first major changes to the EU medical device regulatory environment in over 20 years. The two regulations replace three existing Medical Device Directives (MDD).
These regulations go into effect May 26, 2021 for MDR and May 26, 2022 for IVDR and are applicable for all EU member countries.
What is it? The EU MDR is the set of regulations that governs the production and distribution of medical devices in Europe. Compliance with this regulation is mandatory for medical device companies (legal manufacturers) that want to market or sell their products in the EEA (European Economic Area). There are 27 EU member countries. The EU MDR in its entirety is applicable to finished medical devices.
Why is it necessary? Some of the drivers for this change were due to:
Medical Device Safety scandals in the EU
Varied interpretations of the laws among EU member states
ISO 13485 could not meet all of the needs for this regulation
Limited means to monitor medical device regulations
The above factors are some of the reasons that the MDD is being replaced with the new regulation to ensure compliance with standardized medical device regulations throughout Europe. The structure of the EU MDR contains 10 Chapters, 123 Articles and 17 Annexes which includes 175 pages making it a comprehensive document that covers all aspects of the regulation. The EU MDR regulations are intended to improve the safety and performance of medical devices in Europe and intends to provide a high level of protection for the health of patients and users of these medical devices.
How to be compliant? A summary of activities that must be met in order to be compliant and obtain a CE mark for devices is illustrated below. A brief summary of what technical documentation comprises of is also shown.
What are UDI requirements? One of the requirements of the EU MDR is that all medical devices will now need to be assigned a unique device identification (UDI) code.
Devices which fall under Class III and IIa/b products will need to have their UDI recorded, indexed, and registered on a central EU database called EUDAMED – the European Database for Medical Devices. Manufacturers of these products will be responsible for sharing product data according to the Annex VI Part B of the regulation.
Manufacturers of Class I products will also be required to collect and save product data but will only need to share the information upon request. The EU MDR obligates medical device manufacturers to invest in the software and technology to allow for fast and accurate traceability coding to products and packaging at the individual item level. Noncompliance with these procedures may mean that the medical devices will be pulled off of the market and will no longer be for sale in the EU member states. Manufacturers will be required to audit and check their products on a regular basis to ensure compliance. The illustration below shows the general process for obtaining a UDI.
Who does the EU MDR affect? The EU MDR includes all items sold within the EU. However, all manufacturers that wish to sell their products in the EU need to ensure that they satisfy the EU MDR requirements or the sale of their products will be prohibited; this includes other countries such as the United States selling products to Europe.
How does the EU MDR affect Saint-Gobain? Saint-Gobain is aware of the application and enforcement of the EU MDR come May 2021. Saint-Gobain is not currently a legal manufacturer of any finished medical device, rather Saint-Gobain is a supplier to our customers who are the legal manufacturers. While the MDR requirements are not directly applicable to Saint-Gobain, we are aware of the requirements that our customers must adhere to and are willing to support and provide compliance information where applicable specific to the components and products that Saint-Gobain does provide.