I (as a medical device consultant, US TAG member of IEC SC 62A & 62D & Convener of SC62D JWG9 {IEC/ISO/AAMI/CENELEC 80601-2-58} and a past Notified Body Auditor) am really pleased to see the extremely hard work that has gone into this document and also in the value that it will pass on to all the stakeholders.  There are many stakeholders that were involved in this process including Notified Bodies, NB-MED EN 62304:2006 issues team (Thank you for your hard work.), NB-MED, COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), Manufacturers, OEMs, Standards Developers for EN & IEC & other national standards bodies, Test Houses, Consultants, other countries regulatory bodies (i.e. FDA, Health Canada, etc.) and more.  By use of so many different stakeholders that submitted some of these and other questions this document has a much more consistent view on the implementation issues with the complexity of the topic of medical device software.  

This document is good for learning about your specific implementation issue(s) or if you have the time I would highly recommend reading the whole document, as this will help you understand the intricacies of some of the situations of implementing EN 62304 with respect to the Medical Devices Directives (I’m sure there are more issues but a good portion have been captured by this first version).  I believe this document would be of great help to implement similar guidance documents for many other national medical device regulatory agencies around the world for IEC 62304:2006 (or their national version of the standard).

The Table of Contents gives a good glimpse into the realm of the issues covered in this document and covers the following topics.  I also provide a further glimpse into the document by summarizing some of the specific issues within those sections (these are the indents furthest to the right):

• Introduction (background of the purpose, rationale, the main team members, and how to provide more feedback on the document)
• Abbreviations (Section 1)
• Questions and Answers (Section 2 – Heading of sections 2.1 – 2.7)
• Scope of EN 62304 (Section 2.1)
• Goes into various different scenarios and discusses the implication and implementation issues around these scenarios: such as SAAS, Embedded software including FPGA’s (a hotly contested issue) with single chip computers, Hardware Description Languages specifying FPGAs, Stand alone software, Medical apps, Excel macros, Open & closed systems, Internet or cloud based, Server based systems, Network devices.  In addition to this list of scenarios this section also goes into questions about certification; is Validation included in this standard & if not where does it get covered; what are the expectation of the Notified Bodies with regard to the standard; can you use only part of the standard; why do class A software to EN 62304; what is IEC 82304 about (software only products); among other questions.
• Placing Software as Medical Device on the Market (Section 2.2)
• Explain ‘placing medical device (in this case software or software {s/w} as part of a system) on the market’ in EU if EN 62304 is sufficient, by itself to do this; can I change my intended use and avoid these EU guidelines and regulations; Conformity Assessment routes of the MDD; other countries acceptance / requirement of the standard; can you sign-off on documents electronically; classification of software as a MEDICAL DEVICE; how do Notified Bodies (NB’s) confirm compliance to the standard; among other questions.
• Life-cycle Processes (Section 2.3)
• If s/w development is an outsourced activity what does NB expect; does this std have an equivalent expectation to requirements such as those addressed in FDA Part 11 (Electronic Records & Signatures) in the US; details on the review process at the end of each iteration when updated versions are available during the design and development of the software; does the std require a specific development process; how split up the requirements/responsibilities of the std between the manufacturer and s/w sub-contractor; how do the maintenance activities in the std relate to ISO 20000/ITIL; what are the artifacts (documents) required by EN 62304; at what level does the Problem Resolution Process apply; does software refactoring require a formal change request; what to include in the Technical File to show compliance with EN 62304; how can agile processes be EN 62304 compliant; among other questions.
• Risk Assessment and Risk Management (Section 2.4)
• How deal with risk control measures; when & why can the safety class of a s/w SYSTEM be reduced; how use ISO 14971 with EN 62304; explain Hazard, Cause, Sequence of Events in the context of software; when should we expect additional Software Hazard Analysis guidance within EN 62304; among other questions.
• Classification and Segregation (Section 2.5)
• What is segregation and how do I prove effective; use of a specific class(es) of s/w using COTS (commercial off-the-shelf) what criteria used; how does severity under intended use relate to s/w safety class; is s/w class optional; can you downgrade the classification of the system without a fully hardware protective system; does the compiler need to be classified under EN 62304; how are development platforms & tools related to s/w safety class; relation between Risk Analysis at System level & S/W Safety Classes; explain how the 3 safety classification in the std differ from the FDA’s 3 levels; correlate IEC 61508 SIL levels to EN 62304 safety classifications; s/w classification is a real issue with big implications; among other questions.
• Specifications, testing and tools (Section 2.6)
• I’m a manufacturer of medical devices – how do I document my requirements and tests; web-based medical s/w – does the std have specific requirements related to digital cert’s, (http or https) server requirements; in regard to the std how deal with risk analysis and functional specs; appropriate level of granularity of requirements as design input, design description; which (if any) of the tracing requirements are meant to be bi-directional; questions around deployment of the s/w; what is required of open source code from the std; among other questions.
• SOUP (Software of Unknown Provenance) and Legacy Software (Section 2.7)
• How assess & qualify suppliers of SOUP s/w, when the s/w hasn’t been developed for incorporating into a medical device; what testing & documentation does EN 62304 require for SOUP to meet the std; s/w that is either stand-alone or embedded which was designed prior to publication of EN 62304 but still being placed on the market (legacy product) – what needs to be done; if legacy s/w needs significant change, what processes & documents are required to achieve &/or maintain compliance with EN 62304 and when are changes considered significant;
• References (No Section Number – just after Section 2.7)
• Software Problem Resolution Process (Annex 1)
• Helpful diagram – There are several entry points to the problem resolution process, both during development and maintenance of the software (refer to question 2.3.12).
• SOUP selection, assessment & qualification (Annex 2)
• Flowchart & text to explain an example
• Traceability (Annex 3)
• The 3 flowcharts show an overview of the dependencies which need to be traced according to EN 62304 for all 3 classes – refer to note in bottom left corner of page to know which class the flowcharts apply to (refer to question 2.6.7).
• Position paper on direct diagnosis (COCIR, 2011) (Annex 4)
• As the different stakeholders may interpret this term differently, COCIR and EUROM VI wanted to share their understanding of the term “direct diagnosis”. (Refer to question 2.5.13)

Click on the weblink to see the initial request for questions that we posted on our website 26 May 2012.  To see the posting please go to http://www.eisnersafety.com/do-you-know-how-to-use-en62304-med-dvc-sw-life-cycle-as-implemented-under-themdd-aimdd-doc/

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.

The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the interpretation and implementation of the requirements related to the medical devices sector (MDD, AIMDD & IVDD).  The CMC has issued decisions that need to be considered and implemented by medical device manufacturers.You can find the decisions at http://www.cmc-md.eu/decisions.html.  Four decisions have been issued to date:

1.     Classification and Boderline Queries (23FEB2011) – States classification decisions along with rationales for:

– Wound irrigation solutions containing antimicrobial agents (Class III under rule 13)
– System to determine bacterial contamination in blood products (falls under the IVDD)
– Qualification of Gallipots as medical devices (not a medical device)

2.     Notified Body Best Practice Guides (23FEB2011) – This does NOT affect manufacturers.  It lists the Notified Body Operations Group (NBOG) Best Practice Guides (NBP) and states that all notified bodies are expected to follow these best practices.

3.     Address of the Manufacturer and EU Representative (issued 23Feb2011, updated 7JUN2011) – The ‘address of the manufacturer’ as required in the Essential Requirements on the labels and instruction for use, is the address of the registered place of business of the legally responsible manufacturer and shall include:

– street/road,
– number/house/floor,
– postal code
– city
– state/region and
– country

The same details have to be provided for the address of the authorized representative.
NOTE:  This is more extensive that what the FDA typically requires for an address.

4.     Readability of Instructions for Use (14MAR2012) – It must be assured, that patients and professionals may use the devices as intended by the manufacturer and any ambiguities with regard to the proper and safe use due to deficiencies in the readability of IFUs are avoided.  To that end:

a.     Appropriate checks should be performed by the manufacturer on suitable samples of target users whether IFUs are  really readable and assure proper and safe use of the device.  This includes consideration of font size, quality of translations, and understandability of texts and graphics.
b.     Post-market surveillance procedures have to be sensitive to any indications of bad readability via vigilance or other channels and to any necessary corrective measures.
c.     Special care has to be taken to enable users to properly identify changes to the previous version of the IFU on the basis of a risk assessment.

As dates/revisions are not posted with the document titles, it may be difficult to determine at-a-glance if the decisions have been updated.  Please take care when checking for updates that you inspect the document of interest.

Notified Bodies have been asked to audit these particular points.  You should anticipate that some or all of these issues will be reviewed during your next audit.

If you have any questions on this matter please feel free to contact us at Leo@EisnerSafety.com.

A request for practical questions and issues has just been launched and the invitation letter for FAQ on EN62304 (a short 2 page document) and publication of the FAQ is expected by end of September 2012.  The request document is asking for your questions and any proposed answers (if you have those too) to be submitted by the end of May 2012 so you better hop on the bandwagon and get those off to the e-mail address of FAQ62304@VDE.com.  I think some of these dates may slip a little but that is not confirmed yet.  If I get confirmation of any changes in dates I will advise as soon as I can.

This may sound familiar as this is a similar process to the FAQ document that was issued in Jan/Feb of this year for the EN 60601-1, 3rd ed. Implementation FAQ document.

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