To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as:
- CEN (European Committee for Standardization),
- CENELEC (European Committee for Electrotechnical Standardization),
- ETSI (European Telecommunications Standards Institute).
These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU regulations. In particular, adhering to harmonized standards allows for presumption of conformity with the essential requirements set out in EU legislation, such as the MDR and IVDR.
Role of the Official Journal of the European Union (OJEU)
For a harmonized standard to be applicable for regulatory compliance, its reference must be published in the Official Journal of the European Union (OJEU). This publication serves as the formal recognition of the standard, making it an official tool for ensuring that products, services, or processes meet the necessary EU legal requirements. The OJEU publishes up-to-date lists of harmonized standards, making it a key resource for manufacturers and other stakeholders who need to stay compliant with evolving regulations.
Recent Updates to Harmonized Standards for MDR and IVDR
The following harmonized standards have recently been added to the list and published in the OJEU becoming relevant for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) respectively under the following implementing decisions:
MDR Harmonised Standard
Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products.
The European Commission has published an Implementing Decision regarding medical device harmonised standards. This Implementing Decision includes the following entries to the list of harmonised standards in support of Regulation (EU) 2017/745:
- EN ISO 13408-1:2024: Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)
Implementing Decision (EU) 2024/2631 can be accessed using the following link
IVDR Harmonized Standard
Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects
The European Commission has published an Implementing Decision regarding medical device harmonised standards. This Implementing Decision includes the following entries to the list of harmonised standards in support of Regulation (EU) 2017/746:
- EN ISO 13408-1:2024: Aseptic processing of health care products – General requirements
- EN ISO 20916:2024: In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
Implementing Decision (EU) 2024/2625 can be accessed using the following link
