European Regulatory Update: RoHS Recast, CMC Decision on Labeling, New EU Commission Website

RoHS Recast

The recast of the RoHS Directive (Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment) has been adopted and was published in the Official Journal of the European Union (OJEC) in July of this year. Compliance to the directive is demonstrated through CE Marking.

The RoHS, which restricts use of certain heavy metals in electronic devices, has been extended through the recast to include a broader range of products, including medical devices. Member states must transpose the directive within 18 months of the issuance; the previous version (Directive 2002/95/EC) will continue in-force until then.

CMC Decision on Labeling

The Central Management Committee (CMC) on Medical Devices, formed the end of 2010 by the Competent Authorities to improve the effectiveness of medical device regulations, has issued a decision on labeling for manufacturers and Authorized Representatives. (Click here to see the CMC website.)

The decision, which can be found on the CMC website, reads as follows:

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 decision is intended to achieve a common interpretation of the requirement the manufacturer has in relation to provision of his address on the label and instruction for use.

The same details have to be provided for the address of the authorised representative.

Curiously, this contradicts the European Norm harmonized standard EN 1041:2008, which states: “The full postal address may not be necessary if the information is sufficient to contact them.”

To date, we are only aware of a timeframe from the Swedish Competent Authority, Läkemedelsverket, who has posted a statement indicating that industry will have a year transition period, with full compliance expected by September 1st, 2012.

New EU Commission DG Health & Consumers Website

Visitors to the European Commission’s website will notice a site redesign. The changes are largely aesthetic; however, some content and navigational changes were made and some links and bookmarks will be redirected or broken. Check-out the new design at the EU Commission Website.

Of particular note, the Borderline and classification issues page that previously hosted the most recent version of the Manual on Borderline Classification is no longer available. We expect that this was an oversight that will be corrected shortly; in the meantime, the current version of the Manual (1.11) is available from the Emergo Group Learning Library.

According to Anna Tamarit of the European Commission, as part of the redesign, the Medical Devices website was moved to the Public Health website, as a more logical location for it.

Reminder: EN ISO 13485:2003/AC:2009 Is EN Harmonized

As a reminder, EN ISO 13485:2003/AC:2009 is the harmonized standard, published in the OJEC in July 2010. This is the EN version of ISO 13485:2003/Cor 1:2009, which includes a simple amendment to ISO 13485 to align it to its parent standard, ISO 9001:2000. Although EN ISO 13485:2003 is still widely cited and accepted by many Notified Bodies, it has been expired since 2009 and EN ISO 13485:2003/AC:2009 is the only valid reference according to the OJEC.