News and Views February 2014
As you can see below we are going to the MD&M (Booth: 2363). As always, the intent to visit a trade show is to promote the MDSS services to new prospective clients. However, should you be there it would be a great opportunity to address any topics you may have on your mind in regards to the European CE mark. The show starts next week.
The new European cosmetic regulation (Regulation No. 1223/2009) is in place since the middle of 2012. MDSS always offered services for its clients with cosmetic products according to the old cosmetic directive and as well guided them through the new regulation. We have decided to offer this service to all manufacturers of cosmetic products. The main service is the so called Responsible Person, which differs significantly from the Authorized Representative for the medical devices directive. In addition MDSS supports its clients with the required Safety Assessment and the Product Information File (PIF). Please refer to our website for further details of the Cosmetic services MDSS offers: http://www.mdss.com/cosmetic/cosmetic.htm.
RoHS 2011/65/EC – Directive 201/65/EU of the European Parliament and the council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
We like to remind you that the RoHS 2011/65/EU directive scope now includes as well the medical devices. Please go to our website for more detailed information in terms of the timeline and here is the link to the actual directive: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:en:pdf. Since the RoHS is in place for many years for other consumer products and similar regulations have been implemented all over the world compliance in regards to the product should be in place. However, this needs to be verified and appropriately documented. The directive requires a formal review of the product with establishing a technical file and the issuance of a Declaration of Conformity. An authorized representative (AR) may be implemented for the RoHS. The requirements are clearly outlined in regards to the responsibility of the AR. Please note that the AR according to the Medical Devices Directive is not automatically your AR for the RoHS directive. Most certainly MDSS would be happy to become your AR for the RoHS as well. In order to be accurate it is in our view that the AR for the RoHS in fact is not mandated. However, as always the alternative needs to be carefully considered, which would be your importer. The obligation will be bestowed on him and label requirements apply.
Last year there was some confusion in regards to the EN 980. The standard for Symbols was taken of the list of harmonized standards published in the official Journal and on the website of the European Union. However, the new expected standard EN ISO 15223-1 was not published. Interestingly the reason that no standard was suddenly available is simply because the EN ISO 15223-1 was not published in the official Journal of the European Union. The software unfortunately did not allow reinstating the standard EN 980 on the list since this situation was not foreseen by the software. The standard should shortly appear again on the list of harmonized standards. You may check the website here: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm. This is a nice example of what happens currently in Europe with the harmonized standard. You may have noticed recently that standards in Europe have been updated without any changes to the actual content. European harmonized standards are in place to provide for the presumption of conformity to the essential requirements. In order to clearly identify the requirement the standard may cover, the Annex Z was created. Member states and in particular the European Commission have criticized that the harmonized standards in fact do not provide the presumption in a precise manner as it would be expected for a legal document. Overall the standards are now being reviewed and scrutinized and in particular the Annex Z of the standard is being updated. Here I like to present our point of view. The precise reference to the essential requirement may be helpful in most cases but it also may limit the manufacturer with the solution he may like to adopt for a particular essential requirement. Now, here at this point the discussion may start in terms of whether the standards should reach such a legal status. In that case we may simply make the standard requirements part of the law.