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:   

• • 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: 

• • 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.  

Commission Implementing Regulation (EU) 2022/945 – rules regarding fees that may be levied by EU Reference Laboratories under the IVDR   

Regulation (EU) 2022/945 outlines the rules regarding fees that may be levied by EU Reference Laboratories (EURLs).   

While no specific fees are specified, the regulation highlights the need for transparency in fee structures. As a result, EURLs are required to make fees publicly available on their websites. Further, fees must be capped at 7% of expected testing and operational costs and must be reviewed by the EURL every two years. 

Commission Implementing Regulation (EU) 2022/1107 – common specifications for certain Class D devices under the IVDR 

The EU Commission has adopted new common specifications for several types of Class D IVDs. 

The common specifications provide clarity on requirements related to minimum performance characteristics, number of tests per method claimed by the manufacturer, qualification criteria, acceptance criteria and more. 

Examples of newly introduced common specifications include: 

• • For Detection of Blood Group Antigens in the ABO, RH, KELL, DUFFY and KIDD Blood Group Systems 
  • For Detection or Quantification of Markers of Human Immunodeficiency Virus (HIV) Infection 
  • For Detection or Quantification of Markers of Hepatitis B virus (HPV) Infection 
  • For Detection of Markers of Variant Creutzfeldt-Jacob (vCJD) Disease 
  • For Detection or Quantification of Markers of Severe Acute Respiratory Syndrome Coronavirus 2 Infection 

Please refer to Implementing Regulation (EU) 2022/1107, linked in the heading, for the full list of common specifications.