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 recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU.  You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.

As an overview:

–   Scope:

• • Medical devices (per 93/42/EEC) and IVD devices (per 90/385/EEC) are now included.  They are both part of the general group called “medical devices” in the directive.
  • Active implantable medical devices remain excluded from the requirements of the directive.

–   Limits: The maximum concentrations in homogenous materials are limited, by weight:

• • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)

–   Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from

• • 22 July 2014 for Medical Devices.
  • 22 July 2016 for In-Vitro Diagnostic Medical Devices.

NOTE:  A single CE mark and declaration are acceptable.  (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

–   Exemptions:

• • Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
  • Exemptions available to all devices are listed in Annex III.  Specific exemptions for medical devices are listed in Annex IV.
  • Exemptions for medical devices will be valid for up to 7 years.
  • Requests for exemptions:

• • • Will be filed with the Commission and include all information listed in Annex V.  Most notably, the request must include an analysis of possible alternative substances, materials or designs.
    • Renewals must be requested at least 18 months before the existing exemption expires.
    • Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health and consumer safety impacts.

–   Labeling: The labeling requirements are likely already addressed by MDD or IVDD requirements.  However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.

–   Record Retention:

• • Records must be retained for 10 years after a device is placed on the market.  Note that this may be longer than required by the MDD or IVDD.
  • Records to retain include:
    • Technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,
    • List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and
    • List of  any economic operator to whom you have supplied any electrical or electronic equipment.

If you would like to see some additional information on some of the areas, in the future, that may be implemented refer to the  BSI article that is posted on our website.

Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition.  Please feel free to contact me, Leo Eisner (Leo@Eisnersafety.com) if you have any questions on this subject and I would be more than happy to assist you.

Please contact us if you have questions or concerns.

This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008.  EC/765/2008 is relied on for the term “making available’.

The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.

To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.