In March of this year, we had already reported on the European Commission’s “standardization request”, which allows initial conclusions to be drawn about the standards that will presumably soon be harmonized under the MDR. In July, things actually got underway.

Current status of harmonization in Europe

On July 16, a first implementing decision on the harmonized standards for the MDR was published:

Implementing Decision (EU) 2021/1182.

But which standards exactly have been selected for the first harmonization?

EN ISO 10993-23:2021

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

EN ISO 11135:2014

Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and control of the use of a sterilization process for medical devices (ISO 11135:2014)

& EN ISO 11135:2014/ A1:2019

& EN ISO 11137-1:2015

Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and control of the use of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

& EN ISO 11137-1:2015/A2:2019

EN ISO 11737-2:2020

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

EN ISO 25424:2019

Sterilization of health care products – Low-temperature steam formaldehyde – Requirements for the development, validation and routine monitoring of sterilization processes for medical devices (ISO 25424:2018)

The main focus has been on sterilization processes.

It is very commendable that biological evaluation is also included in the first swing, however, not the main standard, EN ISO 10993-1, as expected, but the newcomer in the standards series, EN ISO 10993-23 “Tests for irritation”, was included. The standard has thus been harmonized without its scope of application. In addition, the publication status is also interesting here: the ISO version has already been published, as has the BS-EN-ISO version; the DIN-EN-ISO version is still lagging behind, but is now available as preliminary version 2021-10 (as of 20.09.2021).

And beware, DIN EN ISO 11137:2020 already hides ISO 11137-1:2006, including Amd. 1:2013 + Amd. 2:2018 and the German version of EN ISO 11137-1:2015 + A2:2019 .

Also on IVDR, the first batch of harmonizations was published on July 19:

Implementing Decision (EU) 2021/1195.

Special standards on the subject of sterilization are also apparent here

EN ISO 11135:2014

Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and control of the use of a sterilization process for medical devices (ISO 11135:2014)

& EN ISO 11135:2014/A1:2019

EN ISO 11137-1:2015

Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and control of the use of a sterilization process for medical devices (ISO 11137-1:2006, including Amd. 1:2013)

& EN ISO 11137-1:2015/A2:2019

EN ISO 11737-2:2020

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

EN ISO 25424:2019

Sterilization of health care products – Low-temperature steam formaldehyde – Requirements for the development, validation and routine monitoring of sterilization processes for medical devices (ISO 25424:2018)

More generally, it can be stated for both the standards harmonized under the MDR and the standards harmonized under the IVDR that even in the area of the selected standards, there are still associated sub-areas that belong, such as the EN ISO 10993 family or the assessment of presterilization prior to sterilization.

Application in the context of the MDR

As already known – standards are not laws, so there is no obligation to apply them. But the road to develop own methods, validate them and align them with the state of the art (i.e. known and harmonized standards) is hard and rocky. Therefore, harmonization is highly desirable so that manufacturers can save themselves some of the line of reasoning required by the MDR to apply standards when the question of prior art comes up.

How the trade-off between harmonized output status, the latest state of the art, but also the established state of the art of standards can be carried out has also occupied the MDCG. It therefore published a corresponding guidance document as early as April 2021:

MDCG 2021-5 Guidance on standardization for medical devices

This document does not provide any simple answers to the question “What applies? What do I have to apply?”, but it does guide you through the decision-making process as the manufacturer responsible for the product within the framework of the New Approach. For this in itself lies with the manufacturer and his line of reasoning. By the way: The previous directives in Europe also functioned according to the principle of the New Approach.

The one standardization exception – labeling symbols

Within the MDR and IVDR, there is one exception in the area of harmonization of standards:

Symbols or identification colors used, if any, shall conform to harmonized standards or specifications. If there are no such harmonized standards or specifications for the area in question, the symbols and identification colors will be explained in the accompanying product documentation.

It is to be hoped that the standard on the use of identification symbols mentioned in the legislative text (MDR, Annex I, 23.1 h; IVDR, Annex I, 20.1 h) will be included in the next harmonization draft and that there will not be a long struggle to harmonize the standard(s) as there was once before. Until then, however, the manufacturer must indeed continue to justify the use of the symbols described in the standard in the sense of the New Approach.

At this point, one can only hope that further harmonized standards, MDCG Guidances and common specifications will appear in a timely manner to build a deeper understanding of products and processes among all stakeholders in accordance with the European regulations. Are you not yet sufficiently prepared to get out of this thicket? We will be happy to assist you.

Please note that all details and lists are not intended to be complete, are without guarantee and are for information purposes only.