Eucomed Guidance Clarifies RoHS Compliance for Medical Device Companies
European medical technology trade association Eucomed has published guidance distinguishing medical device compliance requirements of RoHS 2 (the Recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU) from those of the Medical Devices Directive (MDD 93/42/EEC).
The guidance targets medical device manufacturers who must comply both with the MDD and RoHS 2, a recast of Directive 2002/95/EC that will cover electrical and electronic medical devices starting in July 2014, in order to obtain CE Marking for their products. RoHS 2 compliance means the following:
- Drawing up required technical documentation
- Conducting an internal control procedure in accordance with Module A of Annex II to Decision No 768/2008/EC
- Drawing up a Declaration of Conformity
- Affixing CE Marking to finished product
Although these requirements are similar to those of the MDD, RoHS 2 does not stipulate a mandate for Notified Body assessment of compliance. As such, Eucomed argues that Notified Body audits for MDD compliance should exclude reviews of documents and processes pertaining to RoHS 2 conformity. "Ensuring compliance to the RoHS 2 Directive remains the responsibility of the Member State," states the guidance.
Eucomed states that it knows of no other guidance from industry, Notified Bodies or Competent Authorities regarding overlapping RoHS 2 and MDD compliance issues. Additional guidance from the European Commission ahead of the 2014 compliance deadline may shed more light on what affected manufacturers can expect in terms of RoHS 2 versus MDD compliance requirements for medical device CE Marking in Europe.