On June 17th, 2022, the European Commission adopted two implementing regulations that outline the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Commission Implementing Regulation (EU) 2022/944) as well as the fees that may be levied by EU reference laboratories (Commission Implementing Regulation (EU) 2022/945).
“Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices” outlines how the labs should be operated and how they should ensure that they are qualified to do their job. It lists specific requirements, including employing the appropriate staff.
“Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices” may charge for their work. The laboratories may set their own prices, but they must do it in a transparent way.
What does this mean to you?
These regulations may be of interest to you to better understand how the European Reference Laboratories will organise themselves. If you are a laboratory and are looking into becoming a European Reference Laboratory this is a vital piece of legislation to familiarise yourself with.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
