The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework.

 

 

The European Commission (EC) responsible for regulatory requirements in the sphere of medical devices, has published two implementing decisions providing the lists of harmonized standards to be used in the context of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic devices Regulation 2017/746 (IVDR). The standards covered by the documents are addressing such aspects as biological evaluation of medical devices, sterilization of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment. 

Regulatory Background 

First of all, the authority mentions that under the general rule, should a medical device subject to review comply with the applicable harmonized standards, such a device should be deemed compliant with the regulatory requirements set forth by the appropriate Regulation. 

The MDR, which currently forms a basis of a regulatory framework for general medical devices, has replaced the Directives 90/385/EEC and 93/42/EEC previously used to govern the appropriate relationships; while the Directive 98/79/EC previously used for in vitro diagnostic medical devices has been replaced by the IVDR. To ensure consistency and applicability of the new regulation, the authority has requested the regulatory agencies responsible for standardization in general and in the electrotechnical sphere in particular to assess the applicability of harmonized standards used previously under the Directives in the context of the new Regulation. The aforementioned agencies have duly conducted the assessment requested to ensure the standards used are up to date and reflect the current state of technological development. As a result of this process, new lists of harmonized standards have been formed. These lists contain references to standards that are in line with existing regulatory requirements and thus could be used to assess whether the medical devices intended to be marketed and used in the EU are compliant with the applicable safety and performance requirements. 

Thus, as it was mentioned before, if the medical device in question complies with the applicable harmonized standard(s), it is presumed that it also complies with the respective regulatory requirements related to safety and effectiveness. 

Harmonized Standards – MDR

The first of the implementing decisions published by the EC provides a list of new harmonized standards to be applied in the context of the Medical Devices Regulation 2017/745. According to the document, an existing list of the harmonized standard should be supplemented with the following ones: 

  • EN ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019);
  • EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021);
  • EN ISO 11737-1:2018 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018), EN ISO 11737-1:2018/A1:2021;
  • EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021);
  • EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016), EN ISO 13485:2016/A11:2021;
  • EN ISO 14160:2021 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation, and routine control of a sterilization process for medical devices (ISO 14160:2020);
  • EN ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021);
  • EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021);
  • EN IEC 60601-2-83:2020 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment, EN IEC 60601-2-83:2020/A11:2021. 

 

Harmonized Standards – IVDR

Apart from the standards to be applied for general medical devices, the EC also outlines the ones to be added to the list of standards applicable concerning in vitro diagnostic medical devices. The standards to be added include the following ones:

  • EN ISO 11737-1:2018 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018), EN ISO 11737-1:2018/A1:2021
  • EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021);
  • EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016), EN ISO 13485:2016/A11:2021;
  • EN ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021);
  • EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials, and human samples (ISO 17511:2020).

In summary, the new implementing decisions issued by the European Commission are intended to supplement the lists of harmonized standards allowed to be used in the context of the new regulations. Medical device manufacturers may refer to the appropriate harmonized standards to demonstrate compliance of their products with the respective regulatory requirements. 

 

Sources:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0006&from=EN 

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0015&from=EN 

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