The definition of harmonised standards (HS) is reported in a specific section of EU Medical Device Regulation 2017/745 and precisely in the Article 2 of the regulation. Specifically, harmonised standard means:
a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/201
If we then refer to the Regulation EU 1025/201:
‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.
Use of Harmonised Standards
The use of harmonised standards is defined in the Article 8 of the EU MDR 2017/745.
First, it is stated that European standard published in the Official Journal of the European Union shall be presumed to be in compliance with the EU MDR or IVDR; for this reason this standard can be used as method to demonstrate compliance to this regulation. A classic example is the use of harmonised standards to demonstrate compliance to the General Safety and Performance Requirements (Annex I of the EU MDR 2017/745).
Harmonised Standards and Common Specifications
We have already been talking quite in details about the concept of Common Specifications, for which the requirements are reported in the Article IX of the Regulation. The concept of harmonised standards and common specifications is highly linked.
In fact, in this specific article IX it is mentioned:
(…) where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV.
Basically, common specifications may be adopted to cover specific requirements of the regulation that are not already covered by the harmonised standards.
List of Harmonised Standards
The full list of HS to the EU MDR 2017/745 has not been fully published and currently only an initial number of standards have been published in the Official Journal of the European Union.
Currently, the list of ISO standard harmonised with the EU MDR is the following:
- EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021): this is a standard related to biocompatibility evaluation of medical devices, for which we have already been discussing within QualityMedDev website.
- 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; this topic has already been covered by our website by a specific article related to EtO sterilization and the approach it is possible to use for validation activities.
- 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.
- 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)
- 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).
There are still a lot of missing standards if we consider that under the previous MDD (Medical device directive) and related directives (IVDD and AIMDD), the harmonised standards were:
- 47 for the AIMDD
- 268 for the MDD
- 43 for the IVDD
For this reason, we are expecting more and more standards to be harmonised; the priority topics are the quality management system (EN ISO 13485), risk management (EN ISO 14971), symbols and labelling (EN ISO 15223-1 and EN 15986), and good clinical practice (EN ISO 14155).
Regulatory Compliance in the Transition Period
Obviously it will take time before new harmonised standards will be published in the Official Journal of European Union and during this transition period, in the absence of HSs, industry is concerned on the modalities that are necessary to use for demonstration of compliance to general safety and performance requirements.
The solution is to apply the proposed ranking model:
- The state-of-the-art versions of standards which were harmonised under the previous Directives;
- Other published standards identified as candidates for harmonisation under the respectiveRegulation, or;
- Appropriate international and European consensus standards (ISO/ IEC or EN), given that harmonised standards are mostly originated from them.
EU MDR Implementation Guideline E-book
QualityMedDev has prepared an EU MDR Implementation guideline that covers 10 of the most relevant topics related to regulatory compliance for medical device European market. Specifically, the topics covered by the guideline are:
- MDR QMS Requirements, with a specific focus to the Article 10 of the MDR and IVDR
- Conformity Assessment Routes, providing a guideline on the different strategy that it is possible to follow to get the CE marking for a specific product
- Strategy For Regulatory Compliance, that is a new requirement needed according to both EU MDR and IVDR
- Vigilance Reporting Requirements, essential  to manage adverse events.
- Field Safety Corrective Actions, also in this case very important in case a recall or Field Safety Notice is needed.
- Custom made device, a specific class of medical devices that have particular requirements.
- Legacy devices, an essential topic to fully understand the transition period between MDD and MDR
- Clinical Evaluation, one of the biggest changes for the EU MDR
- Combination products and the related requirements for EU MDR.
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