EU: first MDR and IVDR harmonised standards published

In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union.

Harmonised rules or “harmonised standards” are European standards valid for all EU countries that are developed by a European Standardisation Body (ESO), such as CEN, CENELEC, ETSI and adopted on the basis of a request from the European Commission for the purpose of applying Union legislation on harmonisation (Def. Article 2, point 1 (c) Regulation (EU) No 1025/2012).

These standards are therefore designed to help interested parties to interpret the safety requirements in order to achieve product conformity and enable the presumption of compliance.

EU first MDR and IVDR harmonised standards published
First MDR and IVDR harmonised standards published

First five MDR harmonised standards

On 19 July 2021 the Implementing Decision (EU) 2021/1182 of the Commission gathered on the 16th of July 2021 was published, regarding harmonised standards for medical devices drafted in support of MDR Regulations (EU) 2017/745 by the European Parliament and by the Council.

The paper presents the first five harmonised MDR standards:

1.EN ISO 10993-23:2021
Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021).

2.EN ISO 11135:2014
Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014).
EN ISO 11135:2014/A1:2019

3.EN ISO 11137-1:2015
Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013).
EN ISO 11137-1:2015/A2:2019

4.EN ISO 11737-2:2020
Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019).

5.EN ISO 25424:2019
Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018).

First four IVDR harmonised standards

On 20 July 2021 the Implementing Decision (EU) 2021/1195 of the Commission gathered on the 19th of July 2021 was published, regarding harmonised standards for in vitro diagnostic medical devices drafted in support of IVDR Regulations (EU) 2017/746 by the European Parliament and Council.

The document identifies the first four harmonised IVDR standards:

EN ISO 11135:2014
Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014).
EN ISO 11135:2014/A1:2019

2.EN ISO 11137-1:2015
Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013).
EN ISO 11137-1:2015/A2:2019

3.EN ISO 11737-2:2020
Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019).

4.EN ISO 25424:2019
Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018).

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Sources:

COMMISSION IMPLEMENTING DECISION (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council