In January 2022, the European Commission has published five new standards harmonised under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the Official Journal of the EU (OJEU). They include the amended EU medical devices quality management system standard, EN ISO 13485:2016 and four other standards and were published as harmonised in the context of the IVDR.
Manufacturers applying these standards may thus presume conformity to the corresponding IVDR general safety and performance requirements.
The other four latest harmonised IVD standards are:
- EN ISO 11737-1:2018 on the sterilisation of health care products.
- EN ISO 13408-6:2021 on aseptic processing of health care products.
- EN ISO 15223-1:2021, symbols to be used with information to be supplied by the manufacturer; and
- EN ISO 17511:2021, requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.
It is expected that the amended risk management standard, EN ISO 14971:2019 should, be published in the OJEU in the coming months.
Source: Medtech Insight (an Informa product)