The EU Commission released three new IVDR related Implementing Regulations:
Commission Implementing Regulation (EU) 2022/944 – rules regarding tasks and criteria for EU Reference Laboratories under the IVDR
Regulation (EU) 2022/944 outlines the minimum requirements for EU Reference Laboratories (EURLs) to achieve and maintain compliance. Topics covered include:
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- ensuring proper resource requirements, such as staffing qualifications and continuous training
- maintain and document proper controls over equipment & reference materials
- maintain understanding of current international standards & best practices and ensure they are incorporated into their operating procedures
- confidentiality requirements
- transparency in decision making, e.g., sufficient rationale for use of methods, practices and materials if they diverge from any standards
Further, an EURL must identify at least one person that has overall responsibility for the performance of the tasks set out Article 100(2) of Regulation (EU) 2017/146.Those responsibilities include:
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- verifying performance claims made by the manufacturer
- the compliance of Class D devices with applicable common specifications (when available)
- providing scientific and technical assistance to the Commission, the Medical Device Coordination Group (MDCG), member states and notified bodies in relation to implementation of the IVDR
- contribute to the development of common specifications and international standards
- provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation
- and more
While the person is not required to act out each requirement themselves, they are ultimately responsible for ensuring they occur – similar in concept to the role of the Person Responsible for Regulatory Compliance.