Last month, the European Commission published an implementing decision announcing the future adoption of 15 new harmonised standards against the requirements of the MDR and IVDR. The standards cover, among other things, transfusion devices, emergency ventilators, and device sterilisation – a full list of the new standards can be found in Table 1 at the end of this article.
Technical standards provide rules and guidelines which may be implemented by manufacturers to help ensure compliance with the medical device regulations. The EU elevates the importance of certain technical standards by designating them “harmonised”. Harmonised standards are those standards which are able to provide a presumption of conformity against the relevant regulatory requirements. So, for example, a manufacturer who correctly applies ISO 13485 will automatically be deemed to have conformed with the QMS requirements of the medical device regulations. It is important to note that there is no legal requirement to apply any harmonised medical device standards; nevertheless, many manufacturers choose to do so as an indication of best practice.
The 15 standards included in the Commission’s implementing decision join a growing list of new and existing harmonised standards which are to be adopted by 27 May 2024 at the latest.[1] However, despite these plans, as things currently stand there is a distinct lack of harmonised standards for the new medical device regulations. At present, there are only 17 standards harmonised for the MDR and 11 for the IVDR. These numbers pale in comparison to the 264 standards that were harmonised against the old Medical Device Directive and 41 against the old In Vitro Diagnostic Device Directive.
The lack of harmonised standards creates a problem for manufacturers since both the MDR and IVDR have now entered into application. While there are transition periods for legacy devices previously certified under the old Directives, any new medical devices being placed on the EU market will need to comply with the MDR/IVDR immediately. In such cases, manufacturers can only rely on the very limited list of harmonised standards to help them demonstrate compliance with the regulations.
It is therefore important that the European Standardisation Organisations (in particular, CEN and CENELEC) start making tangible progress on their planned adoptions. We are keeping a close eye on these developments – subscribe to our newsletter to stay up-to-date!
Table 1: newly announced standards to be adopted
|
Standard |
Existing/New |
MDR/IVDR |
|
EN ISO 1135-4:2015 – Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed |
Existing standard to be revised |
MDR |
|
EN ISO 1135-5:2015 – Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus |
Existing standard to be revised |
MDR |
|
EN ISO 10651-4:2009 – Lung ventilators - Part 4: Particular requirements for user-powered resuscitators |
Existing standard to be revised |
MDR |
|
Patient handling equipment used in road ambulances - Part 6: Power assisted chairs (prEN 1865-6) |
New standard to be drafted |
MDR |
|
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (EN ISO 11737-3) |
New standard to be drafted |
MDR |
|
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004) |
New standard to be drafted |
MDR |
|
Manufacture of cell-based health care products - Control of microbial risks during processing - Amendment 1 (ISO 18362:2016/DAMD 1) |
New standard to be drafted |
MDR |
|
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (EN ISO 22441) |
New standard to be drafted |
MDR |
|
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO/DIS 80369-2:2021) (prEN ISO 80369) |
New standard to be drafted |
MDR |
|
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (prEN ISO 80601-2-84) |
New standard to be drafted |
MDR |
|
Respiratory infection prevention devices for self- and third party protection - Requirements for different performance classes and test methods |
New standard to be drafted |
MDR |
|
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (EN ISO 11737-3) |
New standard to be drafted |
IVDR |
|
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004) |
New standard to be drafted |
IVDR |
|
Manufacture of cell-based health care products - Control of microbial risks during processing - Amendment 1 (ISO 18362:2016/DAMD 1) |
New standard to be drafted |
IVDR |
|
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (EN ISO 22441) |
New standard to be drafted |
IVDR |
[1] Excluding the new additions discussed in this article, there are currently 224 harmonised standards which are to be adopted for the MDR and 49 for the IVDR - the full list of standards can be found in Commission Implementing Decision C(2021) 2406