What are EU Reference Laboratories under IVDR? EURLs
A new legislative framework on medical devices Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The IVDR had a date of application of 26 May 2022.
In October 2022, the European Commission published Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. In addition to setting the priorities, the Plan will serve as a living document to monitor their implementation.
The Section 3 of this Document talks about the EU reference laboratories [EURLs]. On 5th August 2022 – the EU Called for EU Reference Laboratories nominations to the member states. The deadline for Member States to submit nominations to the Commission is 31 March 2023. Interested candidate laboratories should contact their Member State for further information and instructions.
EU reference laboratories have never previously been set up in the field of IVDs. These laboratories, if designated,
- Will carry out additional tests on class D devices that fall in their scope of designation.
- They will in particular verify the performance of class D devices and compliance with any common specifications before the device is placed on the market.
- Furthermore, they will carry out tests on samples or batches of CE-marked class D devices before they are placed on the market.
- The EU reference laboratories will also make their expertise available for a range of advisory functions.
Therefore their establishment is important for high-level, consistent assessment of class D devices in the Union. The Regulation does not make it mandatory to have an EU reference laboratory for any kind of class D device – it is at the discretion of the Commission to designate them. If no EU reference laboratory is designated for a particular device, those requirements are not applicable.
Manufacturers of Class D Diagnostics need not worry about the EU reference Laboratories for the short run. But, whenever the European Commission introduces the EU reference Laboratories, manufacturers will need to ensure complete compliance with the requirements.
Our experts believe that if the Manufacturers –
- Have a robust regulatory strategy
- Strong Quality Management system
Then, any additional requirements or changes in regulations will never disturb the smooth sales of Medical products in different markets.
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