In March of this year, we had already reported on the European Commission’s “standardisation request”, which allows initial conclusions to be drawn about the standards that will presumably soon be harmonised under the MDR. In July, things actually got underway.
Current status on harmonization in Europe
A first implementing decision on harmonised standards for the MDR was published on 16th of July:
But which standards exactly were 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 routine control 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 control of sterilization processes for medical devices (ISO 25424:2018)
The main focus was on sterilization processes.
It is very laudable that biological evaluation is also included in the first batch, although not the main standard, EN ISO 10993-1, as was to be expected, but the newcomer to this series of standards, EN ISO 10993-23 “Tests for irritation”. The standard has thus been harmonized without its framework. 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 encapsulates ISO 11137-1:2006, incl. Amd. 1:2013 + Amd. 2:2018 and the German version of EN ISO 11137-1:2015 + A2:2019.
The first wave of harmonisation under the IVDR was also published on 19 July:
Special standards on the subject of sterilisation are also evident 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 routine control 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 control of sterilization processes for medical devices (ISO 25424:2018)
In general, it can be stated for both the standards harmonized under the MDR and those harmonized under the IVDR that even in the area of the selected standards, there are still associated sub-areas, such as the EN ISO 10993 family or the assessment of bioburden 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. the known and harmonized standards) is hard and rocky. Therefore, harmonization is highly desirable so that manufacturers can save themselves some of the line of argumentation required in the MDR for the application of standards when it comes to the question for the state of the art.
The MDCG was also concerned with how to weigh up the harmonized state of the art, the latest state of the art, but also the established state of the art of standards. It therefore published a corresponding guidance document as early as April 2021:
This document does not provide simple answers to the question “What is valid? What do I have to apply?”, it does, however, guide you, the manufacturer who is responsible for the product, through the decision-making process within the framework of the New Approach thinking. For this decision making is in itself up to 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 standardisation exception – labelling symbols
There is a single exception within the MDR and the IVDR with regards to harmonization of standards:
Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
It is to be hoped that the standard on the use of labelling symbols mentioned in the legal text (MDR, Annex I, 23.1 h; IVDR, Annex I, 20.1 h) will be included in the next harmonization bundle and that there won’t be a long struggle for harmonization of the standard(s) as it has been there 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 the near future in order to build up a deeper understanding of the products and processes in accordance with the European regulations among all those involved. Are you not yet sufficiently equipped to get out of this thicket? We will be happy to help you.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
