Harmonized standards for the Medical Devices Regulation 2017/745
How do you monitor the EU Official Journal? Do you treat yourself to a look at the EU Official Journal in the morning over coffee (or tea) to check for updates?
Here's an example: On October 20, 2025, the Commission published Implementing Decision 2025/2078 amending Implementing Decision 2021/1182 in the EU Official Journal. It lists four harmonized standards which, as of the effective date of October 20, 2025, will trigger the presumption of conformity with the relevant protection objectives from the MDR when applied and fulfilled. However, it is not indicated whether there are predecessor standards:
ANNEX
The following entries are added to the Annex to Implementing Decision (EU) 2021/1182:
No. Reference of the standard
"33. EN 13795-1:2025 // Surgical clothing and drapes - Requirements and test methods - Part 1:
Surgical drapes and gowns
34 EN 13795-2:2025 // Surgical clothing and drapes - Requirements and test methods - Part 2:
Clean air garments
35. EN 14683:2025 // Medical face masks - Requirements and test methods
36. EN 14180:2025 // Sterilizers for medical use - Low temperature steam-formaldehyde sterilizers -
Requirements and test methods."
Ex. EN 13795-1:2025
The predecessor standard is EN 13795-1:2019-04. It is interesting to note that this standard and two other predecessor standards were not previously published under the Medical Devices Regulation, but only under the repealed Medical Devices Directive 93/42/EEC. In this respect, there was a gap here.
This information is completely missing in this implementing decision, meaning that users have to make some effort to establish these connections. Although the EU Commission provides "informative" Excel tables, these are not updated on a daily basis and the Commission does not accept any liability for their accuracy. Standards management systems provide very efficient support here and the context can be established at the click of a mouse.
DIN CEN/TS 17676:2025-10
Some of our readers will certainly also go to the gym. Now the working committee NA 112-01-10 AA "Fitness studios" in the DIN Standards Committee for Sports and Leisure Equipment (NASport) has published the "Guidelines for the safe operation of fitness studios during the outbreak of infectious diseases" as a pre-standard. This pre-standard is based on the CEN Technical Specification CEN/TS 17676.
A little riddle: Do you know what a pre-standard or technical specification is in comparison to a standard?
The answer can be found in DIN 820-4, 6.1.2 "Standardization work - Part 4: Course of business":
"A Technical Specification is the result of standardization work which is not published as a standard by DIN due to certain reservations regarding the content, due to the development procedure deviating from a standard or in consideration of the European framework conditions.
The content of a technical specification including its annexes may contain requirements. Competing technical specifications in one and the same subject area are permitted.
In addition to the deviations from the principles and rules for standardization work in the standards of the DIN 820 series listed under 6.1.1, the following deviations apply to technical specifications:
a) A technical specification must be reviewed after 3 years to determine
- whether it can be converted into a standard (if no significant changes are made - e.g. extension or limitation of the scope, deletion or addition of procedures without replacement - the manuscript procedure according to 6.4 may be applied, otherwise a draft standard must be published),
- whether it must be withdrawn without replacement,
- whether it must be revised or
- whether it must be retained unchanged as a technical specification; this decision must then be reviewed annually.
b) During the updating period of a technical specification, an ordinary standardization procedure on the same subject may already be initiated."
Reference (in German) → https://www.din.de/de/ueber-normen-und-standards/din-norm/din-820-4-ausgabe-2021-02--189110
If you have any questions about these or other publications in the EU Official Journal, please send us an email or use our contact form.
Author's note
This article has been machine translated into English.
DEFINITIONS AND ABBREVIATIONS
A harmonized standard is a European standard adopted on the basis of a mandate from the Commission to implement Union harmonization legislation.
Regulation (EU) 2017/745 on medical devices is also known as the Medical Device Regulation (MDR) or the European Medical Device Regulation.
