The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation & guidance documents and more…

If you are looking for information on Medical Devices under the MDD this is a good link to look at for lots of information on the subject.

If you are looking for information on Medicines legislation & directives this is a good link to look at for lots of information on the subject.

They even set-up a page for New Technologies Forums for both Medicines and Medical Devices.

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.

Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered for a recast; also other parts of EU legislation are being revised. One of these is the RoHS Directive that regulates hazardous substances in electrical and electronic equipment (EEE) in the EU. Work on the revision started in 2008 when it was called RoHS 2 (or RoHS II). By now the revision is ready and will be presented as “RoHS Recast,” because the existing directive will be repealed and replaced rather than simply amended.

Utilizing the EU’s New Approach and New Legislative Framework, the new directive will move specification of restricted substances and covered EEE to the Annexes so that they can be easily “adapted to technical progress” (ATP). The CE mark will be required for compliance; procedures for conformity assessment are specified; and standards developed by European Standards Organizations are utilized.  The European Parliament adopted the “consolidated text” for RoHS Recast late 2010, and the final step to approve legislation in the Council of the European Union is very near.

The change will significantly impact the medical device field. Where currently all medical devices and IVDs are exempt from the directive, the automatic exclusion from RoHS will disappear for MDD and IVDD devices, while it remains in place for active implants under AIMDD. The new legislation has foreseen various transition times. Medical devices, as well as monitoring and control instruments, must comply within three years after publication in the EU Official Journal, whereas IVDs must comply within five years.

The six original RoHS substances (lead, mercury, cadmium, hexavalent chromium, PBB and PBDE as identified in RoHS Annex II) are still the only ones restricted, and no changes were made to their allowed concentrations.  However, future additions to the list remain likely. The Environmental Committee report recommended that brominated flame retardants, chlorinated flame retardants, PVC, chlorinated plasticizers, DEHP, BBP, and DBP be restricted. The COR Committee opinion expressed regret that HBCDD, DEHP, BBP, and DBP were not included. Moreover, a full evaluation of the new Annex II, specifying the banned substances, is required in three years.

It is possible for individual manufacturers to apply for specific exemptions. (Specific procedures have been set up to grant the information; annex V or RoHS recast provides details.)  A list of exemptions granted for 7 years exists. The application needs to be submitted before 2014, realizing that the renewal to exemptions has to be sent 18 months before the deadline.

If no exemption is successfully obtained, then to comply with the Directive the manufacturer will need to set up a self-declaration of conformity referring to the RoHS. In order to do so, manufacturers must maintain technical documentation, cite relevant harmonized standards, implement internal production controls, and keep a register of nonconforming products. CE mark is required on the finished product, as well as manufacturer’s name, trademark, contact address, and a type, batch or serial number (to facilitate recalls) should be present on the labelling.  The EC Declaration of Conformity (specified in annex VI) that accompanies the finished product should be in the language of the local market. In the event that the product is manufactured outside the EU, then the EU importer who will share the responsibility for compliance with the manufacturer is also needed.

The EU Commission website to monitor for news of the recast of RoHS Directive is:http://ec.europa.eu/environment/waste/weee/index_en.htm

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.

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.

Eisner Safety Consultants; a leading name in providing regulatory, quality system, and product safety consulting for the medical, in-vitro diagnostic, and hi-tech industries; proudly announces the launch of its revamped and improved website.

We have kept the website simple, attractive yet easier to navigate and user-friendly. We have also added several new features including:

• A news blog focused on the medical & IVD industries specifically towards regulatory, product safety and quality systems (subscribe to RSS feed)
• Updated resources on our Weblinks and Library pages
• AdvaMed Smartbrief News
• Bookmarking and sharing services to your favorite services

Coming by Mid Sept ’09 we will add our updated newsletter service.