The REACH Regulation was published on 1 June 2006 and was enforced on 1 June 2007 in the 27 Member States. By 2017, REACH will apply to almost 30.000 chemical substances which are currently in use across Europe. As this corresponds to a huge programm and in order to reach this objective, a phased implementation programm was decided to run over 11 years.
REACH requires all manufacturers and importers of medical devices to provide customers with information on whether their products contain more than 0.1% of any "Substances of Very High Concern" on the REACH "Candidate List" of substances. This list is constantly updated by ECHA (European Agency for Chemicals) and is expected to count 1500 entries by the end of 2015 (138 at January 2012).
Since June 2010, medtehc industry is required to provide additional information to professional customers on the candidate substances used in medical devices and the safe use of the equipment. Information about the content of SVHC has to be sourced from the supply-chain involving substance producers, formulators, distributors and suppliers.
Substances in the candidate list can be proposed for inclusion into Annex XIV, substances subject to authorization. Once a substance is added to Annex XIV it cannot be produced, imported or used unless a specific authorization is granted to the Comapny requesting for itn and only for limited time.
ECHA published a lot of Guidance Documents, available on the website for articles producers. Manufacturers of medical devices are particularly interested in the following ones:
Guidance to substance in articles: provides guidance on all obligations for article manufacturers
Recognizing the complexity of this regulation and the impact for the MedTech sector, COCIR launched several initiatives to support its Members.