EN ISO 14971:2019 Medical devices – Application of risk management was published in January 2020, but how does the EN version differ from the ISO version and what are the implications for the Medical Device manufacturer? Our Expert Tutor John Lafferty highlights that key differences to be aware of in this article.
Topics covered in this article:
– EN ISO 14971:2019 has been published without Z Annexes
– Common Specifications Are Not Yet Published
– Decoupling (The separation of EN Medical Device standards from the EU Medical Device Regulations)
– Implications for the Medical Device manufacturer
– Outstanding Questions relating to EN ISO 14971:2019
– Ongoing updates on ISO 14971:2019
– 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. 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:
a. Compliance with an EN standard no longer gives a presumption of compliance with (the relevant parts of) the European Medical Device regulations.
b. There will be a (temporary) lack of harmonised standards that the Medical Device manufacturer can use to achieve compliance with the Medical Devices regulations EU MDR 2017/745 and EU IVDR 2017/746. This situation will exist until EN Standards are published by CEN and subsequently published by the European Commission in the Official Journal of the European Union.
c. Following the withdrawal of EN ISO 14971:2012 (and consequently its very useful Z Annexes) there is no official document to direct the Medical Device Manufacturer as to which parts of EN ISO 14971 they can use for compliance with European Medical Device regulations. Similarly, there is no official document to direct a manufacturer as to when they must ignore the requirements of EN ISO 14971:2019 and comply directly with the requirements of the regulations
d. Manufacturers will have to comply directly with the EU MDR 2017/745 and EU IVDR 2017/746 in matters such as Risk Acceptability, Risk Reduction Options and Benefit-Risk Analysis.
e. If manufacturers claim compliance with EN ISO 14971:2019 they will need to clearly state that they are not adhering to certain requirements of that standard e.g. Treatment of Negligible Risk, As Low-as-Reasonably-Practicable (ALARP) and those referred to at d. above.
5. Outstanding Questions relating to EN ISO 14971:2019
In a previous blog on this subject, John outlined 3 questions relating to ISO 14971:2019 – some of these questions have been answered with the publication EN ISO 14971:2019. Below is an update on these answers and remaining questions.
1. Which standard will be accepted for compliance with the EU MDRs – a. EN ISO 14971:2012 or b. EN ISO 14971:20XX?
Answer:We now know that the EN standard is EN ISO 14971:2019 but we also know that compliance with it does not necessarily lead to compliance with the European Medical Devices Regulations and that we must comply with the regulations directly to be sure of compliance.
2. How to apply the new standard ISO 14971:2019 without the availability of the associated guidance document ISO TR 24971:20XX?
This question still remains.
3. When will the EN standard EN ISO 14971:20XX and the guidance document ISO TR 24971:20XX be published?
Answer: ISO Draft TR 24971:2020 is at the approval stage, with the result of the approval vote expected by the end of March 2020 and publication after that.
We now know a good deal more about EN ISO 14971:2020. All we are waiting for now is the publication of ISO TR 24971:2020 and the republication of EN ISO 14791.
6. Ongoing updates on ISO 14971:2019
7. ISO 14971:2019 Training Course Information
For full details of the training course and booking information visit the course page here Quality Risk Management and ISO 14971:2019
Course Content: The course will cover the principles and practices of Risk Management and the actions that Medical Device Manufacturers need to do to comply with ISO 14971:2019 and the Medical Devices Regulations.
Note 1: A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. The references of harmonised standards must be published in the Official Journal of the European Union. Source: www.ec.europa.eu
Note 2: A list of harmonised standards can be found at https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en Please be aware that the current (as of 21st Feb 2020) published list of harmonised standards relates to the three Medical Devices Directives and not to the Medical Devices Regulations 2017/745 and 2017/746.
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