June 7th 2019 the Commission Implementing decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices appeared in the Official Journal of the European Union.
The issuing entities designated to operate a system for assignment of UDIs pursuant to Regulation 2017/745 and 2017/746 are:
- GS1 AISBL
- Health Industry Business Communications Council (HIBCC)
- Informationsstelle für Arzneispezialitäten — IFA GmbH
This designation is valid for a period of five years from June 27th 2019.
What does this mean to you?
This standard identifies the principles that underpin clinical performance studies for IVDs, to ensure the conduct of the clinical performance study will lead to reliable and robust study results. It is highly advisable to adhere to this standard for all your clinical performance studies.
Clinical performance studies organised by Qarad are conducted in accordance to the requirements laid down in the ISO 20916:2019 standard.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.