Eurofins’ Finland’s Notified Body achieves designation under the new Medical Devices Regulation (EU) 2017/745
On April 7th, 2021, Eurofins Expert Services Oy (No. 0537) became a Notified Body designated under the new Medical Devices Regulation (MDR). Eurofins can now offer, to medical device manufacturers worldwide, certification services according to Regulation (EU) 2017/745 for European market access covering an extensive range of medical device technologies1.
The new Medical Device Regulation (MDR) enters into full application on May 26th, 2021, with this date marking the end of the transition period between Regulation (EU) 2017/745 and the current European Medical Devices Directives 93/42/EEC (MDD) & 90/385 EC (AIMD).
Medical devices currently covered by a valid certificate issued in accordance with these Directives can be placed or put in service on the European Market until May 26th, 2024, and made available until May 26th, 2025, if they continue to comply with either of these Directives and do not undergo any significant changes in the design and intended purpose.
In anticipation of this, Eurofins Expert Services Oy identified and implemented the necessary processes to ensure the continuity and quality of its services and allow manufacturers to maintain, on the European market, the medical devices currently covered by certificates of conformity issued under the MDD.
If the device undergoes any significant changes in the design or intended purpose, it must undergo certification to the MDR as if it was a new product. Eurofins can guide manufacturers through this process to ensure continuing European market access.
In parallel with its successful MDR designation, Eurofins Expert Services Oy, a Notified Body for the Directive 98/79/EC (IVD MDD), applied for its designation under the in vitro diagnostic medical device Regulation (EU) 2017/746 (IVDR). This process is underway, and Eurofins Expert Services Oy is determined to complete it no later than Q4 of 2021.
Alongside the MDD, IVD and MDR Notified Body certification services, Eurofins provides a comprehensive suite of medical device solutions, including EMC, Safety and Wireless testing for manufacturers looking to gain global market access and achieve regulatory compliance.
For more information about our MDR designation, please contact the Eurofins Finland medical devices team by email or visit our website.
1 The scope of designation for Eurofins Expert Services Oy is available online, on the NANDO website (New Approach Notified and Designated Organisations), the European Commission's information system.