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 regulationsĭ. 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. 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.Ĭ. 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. Compliance with an EN standard no longer gives a presumption of compliance with (the relevant parts of) the European Medical Device regulations.ī. Some of the implications for the Medical Device manufacturer arising from the decoupling of EN ISO 14971:2019 are:Ī. Implications for the Medical Device manufacturer It is envisaged that timeline for the republication of EN ISO 14971 will be relatively short and may occur in 2020.Ĥ. Now that it has received a mandate from the European Commission, CEN plan to republish EN ISO 14971 with Z Annexes. Following the Decoupling decision EN ISO 14971:2019 was published in January 2020.
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. 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 46. Decoupling (The separation of EN Medical Device standards from the EU Medical Device 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.ģ. 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. 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. 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. Common Specifications Are Not Yet Published Compliance with a Harmonised Standard allows automatic presumption of compliance with the relevant parts of European Legislation.Ģ.
This enabled the European Union to publish EN standards in the Official Journal of the European Union as Harmonised Standards. These Z Annexes document any differences between the requirements of the ISO standard and the related requirements of the European Medical Device regulations. Normally EN standards are published with Z Annexes placed in front of the ISO version of the standard. 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. EN ISO 14971:2019 has been published without Z AnnexesĮN ISO 14971:2019 Medical devices – Application of risk management is now available for purchase from the normal standards publication websites such as and from national standardisation bodies.
– ISO 14971:2019 Training Course Informationġ. – Outstanding Questions relating to EN ISO 14971:2019 – Implications for the Medical Device manufacturer – Decoupling (The separation of EN Medical Device standards from the EU Medical Device Regulations) – Common Specifications Are Not Yet Published – EN ISO 14971:2019 has been published without Z Annexes Part 1ĮN 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. What is the difference between the EN and ISO versions of 14971:2019.
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