Eisner Safety Consultants

On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.

This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity”

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

On 20 September 2011 a Report was issued from the Directors’ Contact Group between Commission, ECHA & Industry Associations on Meeting the 1st REACH Registration Deadline.  The first deadline period was from FEB 2011 to MAR 2011.

The Notes and summary of the Report are repeated below:

Notes:

The report is written with a multiplicity of audiences in mind. First and foremost it is intended to inform the Management Board of the European Chemicals Agency (ECHA) and the Competent Authorities on REACH And Classification And Labeling (CARACAL) of the work of the DCG. It is though also intended to provide a transparent account to other interested parties, in particular national and EU industry organisations and their members, non governmental organisations representing workers, consumers and the environment and similar organisations in third countries interested in REACH and CLP.

This report has been agreed by the members of the Directors’ Contact Group.

Summary

The adoption of Regulation (EC) No 1907/2006 of the European Parliament and the Council on 18 December 2006 concerning the Registration, Evaluation and Authorisation of Chemicals (REACH) marked a milestone in the modernisation of the European chemicals legislation. REACH is widely recognised as being the most ambitious and comprehensive piece of chemicals legislation in the world.

REACH set 30 November 2010 as the deadline for all manufacturers and importers of high volume substances and substances of particular concern to register their chemicals, thus subjecting a large proportion of the volume of chemicals on the EU market to the REACH rules.

Recognising that fulfilling the REACH requirements by this deadline would present significant challenges to industry, the Commission invited six industry organisations and the European Chemicals Agency (ECHA) to nominate members to and thereby set up the Directors’ Contact Group (DCG). The purpose of the DCG was to monitor progress towards meeting the first registration deadline and to reduce practical obstacles to registration identified by industry.

In the course of 2010 the DCG identified and addressed in total 28 issues, contributing to the successful completion of registration by the first deadline. The practical co-operation between the Commission, ECHA and industry associations therefore proved successful, demonstrating that obstacles to registration can be reduced. This clear learning from the efforts in 2010 made the Commission decide to continue the work of the DCG with the aim of continuing the registration success story through the next major registration deadline of 31 May 2013.

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:

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.

On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”.  There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance).

The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:

• are used as an accessory to a regulated medical device;
• or transform a mobile platform into a regulated medical device.

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”

Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.