Topics covered in this article:

1. EN ISO 14971:2019 has been published without Z Annexes
2. Common Specifications Are Not Yet Published
3. Decoupling (The separation of EN Medical Device standards from the EU Medical Device Regulations)
4. Implications for the Medical Device manufacturer
5. Outstanding Questions relating to EN ISO 14971:2019
6. Ongoing updates on ISO 14971:2019
7. ISO 14971:2019 Training Course Information

1. EN ISO 14971:2019 has been published without Z Annexes

EN ISO 14971:2019 Medical devices – Application of risk management is now available for purchase from the normal standards publication websites such as www.iso.org and from national standardisation bodies. If you have already purchased the ISO version, ISO 14971:2019, then there is no need to purchase the EN version, the reason being that there is absolutely no difference between the two versions of the standard. Normally EN standards are published with Z Annexes placed in front of the ISO version of the standard. These Z Annexes document any differences between the requirements of the ISO standard and the related requirements of the European Medical Device regulations. This enabled the European Union to publish EN standards in the Official Journal of the European Union as Harmonised Standards (see also Note 1 below). Compliance with a Harmonised Standard allows automatic presumption of compliance with the relevant parts of European Legislation.

2. Common Specifications Are Not Yet Published

The reason that the EN ISO 14971:2019 was published without Z Annexes lies in the Medical Devices Regulations; EU MDR 2017/745 and EU IVD MDR 2017/746. These regulations state; “Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account of European and international standards.” It was envisaged that Common Specifications would be developed for items such as Clinical Evaluation and Risk Management; however, these Common Specifications have not yet been published meaning that there was no document other than the MDRs themselves against which to evaluate ISO 14971:2019. In spite of this, the European Commission, last week, issued CEN (and its sister organization CENELEC) with mandates to produce Harmonized Standards to meet the requirements of the Medical Devices Regulations. So it would appear that the European Commission has now decided to push ahead with the publication of harmonised standards in the absence of the Common Specifications.

3. Decoupling (The separation of EN Medical Device standards from the EU Medical Device Regulations)

In the meantime, in the absence of the Common Specifications or a mandate from the European Commission, CEN took a decision to publish EN Standards without reference to the Medical Devices Regulations 2017/745 and 2017/746. This decision was a major step by CEN. The separation of EN Medical Device standards from the EU Medical Device Regulations is known as Decoupling, it represents a major departure from the practices of the past and has significant implications for the Medical Device manufacturer. Following the Decoupling decision EN ISO 14971:2019 was published in January 2020. Now that it has received a mandate from the European Commission, CEN plan to republish EN ISO 14971 with Z Annexes . It is envisaged that timeline for the republication of EN ISO 14971 will be relatively short and may occur in 2020.

4. Implications for the Medical Device manufacturer

Some of the implications for the Medical Device manufacturer arising from the decoupling of EN ISO 14971:2019 are: