Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available.  Be forewarned that the document is not yet adopted by the NBRG, which can only be done at the next Meeting in October 2014.  Hopefully it will be adopted at that meeting.  I will check in with my NBRG Risk Management Working Group contacts to find out if they know more about that issue.

But let’s take this chance to review a little about the document and the history of the EN ISO 14971:2012 Annex Z’s.  Future posts will get into more details. The following 3 paragraphs come straight from the introduction of the document as the Working Group summarizes the situation really well.  I happen to know a couple of these working group members personally and I know they have a very good handle on the situation and they have provided some very good background.  

In October 2010, the regular review of ISO 14971:2007 which is the basis of EN ISO 14971:2009 was closed by a broad majority of votes confirming the existing status and the wide-spread acceptance of this standard in the medical devices community, including competent authorities. In November 2010, the European Commission raised a formal objection against the use of several harmonized standards, including EN ISO 14971, followed by an in-depth assessment of the coverage of the Essential Requirements of the Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) by these standards.

As a result of these objections, the Annexes Z to EN ISO 14971 were modified, resulting in EN ISO 14971:2012. This amendment of the EN ISO 14971 standard did not modify the normative parts of ISO 14971:20071. The Annexes Z describe the extent of presumption of conformity that can be based on application of the normative requirements of ISO 14971 alone. The “content deviations”, expressed in the revised Annexes Z, between ISO 14971:2007 and the Medical Device Directives have been commented by many experts in the field of risk management and resulted in diverging interpretations from different stakeholders (e.g. manufacturers, notified bodies, competent authorities).

This document has been prepared as a Notified Body Consensus Paper by a working group headed by the NBRG Vice Chair, with representatives from several European Notified Bodies and industry associations COCIR, Eucomed, EDMA and ZVEI. The paper aims to provide a practical interpretation of these “content deviations” to the Medical Device Directives and give guidance as to how to implement the risk management requirements. The work consolidates prior publications of various sources and is intended to facilitate common understanding between industry and Notified Bodies.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation 

• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

This post is a status update on the NBRG RMWG Risk Management Consensus Document

30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012.  This meeting has come about because the NBRG RMWG received some feedback recently from the EU Commission and they will consider it and roll it into this document.

The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives). The previous plan was to have this Consensus document completed and released by Mid to Late April ’14 but at this point it is hoped the NBRG RMWG will have a final released document by the end of June 2014. We look forward to sending good news about the progress of this document over the next month or so.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

The NBRG (Notified Body Recommendation Group) Risk Management Working Group is working to put together a consensus document.  A call to industry has been sent out to ask for participation in a survey on how your risk management system aligns with EN ISO 14971:2012 that will help in the direction of this consensus document so please take part in it.  Read the article for more details and a post that links to the survey.

Past posts on this subject include:

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

The live link to the survey is on the fourth set of pages on slide deck and is slide 8 of the presentation.  The more participants in the survey the more likely your voices will be heard and we hope this will improve the potential outcome of the process.

On 8 February we posted the NBRG letter which was a Call for Industry Participation in the Survey on Understanding Annex Z of EN ISO 14971:2012. 

[slideshare id=32021997&doc=mdmwestpresentationonnbrgconsensusdocumentoneniso14971201211feb2014-140306235842-phpapp01&type=d]

Team-NB is a voluntary organization of Medical Device Notified Bodies (doesn’t represent all EU NB’s under the 3 Medical Device Directives) and as of 12 Nov 2012 there are now 35 members.  During the 9 Oct 2012 Assembly in addition to the adoption of the CoC three (3) new members were unanimously added (LGA InterCert GmbH – Nurnberg Deutschland, UDEM – Ankara Turkey, and ALBERK QA TECKNIC – Istanbul Turkey).

The Version 3.0 Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC, & 98/79/EC is a very thorough document which is 31 pages long and includes the Unannounced Inspections (or Unannounced Audits of Medical Device Manufacturers that are Certified under the applicable Medical Directive) which comes from the recently proposed Medical Device Regulations.  As of the 30 October 2012 News Release 14 Notified Bodies had signed the V3.0 CoC and 2 additional NBs (LNE/G-MED & DQS) signed prior to 12 Nov 2012.  It is anticipated that more NBs will sign in the near future as they adopt the policies covered within the V3.0 CoC which shows their commitment to improve the implementation of the EU CE marking certification of medical devices through clarified organizational criteria, management of competence and assessment practices.  The major topics in the document are:

• Implementation, enforcement and monitoring of the Code of Conduct
• Qualification and Assignment of Notified Body Assessment Personnel
• Minimum time for Notified Body assessments
• Unannounced visits
• Sampling of class IIa and IIb technical files
• Design Dossier Reviews
• Rules for subcontracting
• Rules for Certification Decisions 

Further revisions will be made to be in line with the new developments of the European legislation.

On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg