Reference to directive 2007/47 on declarations of conformity and certificates does not have a legal basis before the 21 March 2010 and would unduly discriminate against products after that date.
Brussels, 11 June 2009 - On 21 March 2010 Directive 2007/47/EC which modifies the Medical Devices Directives 93/42/EEC and 90/385/EEC will come into effect. From this date onwards, compliance with the latter two directives will include compliance with the requirements of Directive 2007/47/EC too. Until 21 March 2010, reference to 2007/47 does not have a legal basis but after this date unnecessary reference to 2007/47/EC on Certificates and declarations of conformity would create uncertainties on the meaning of CE marking.
Recently, many stakeholders have been debating on whether accompanying documents to devices compliant with the new requirements should refer to revising Directive 2007/47/EC or to the original directives alone. Eucomed, the European Medical Technology Industry Association, believes that confusion with respect to the CE marking of medical devices should be minimised as much as possible and in this light the association recommends not referring to the 2007/47/EC Directive but rather to 93/42/EEC and 90/385/EEC. Moreover, the Commission has indicated that referring to the revising directive is neither obligatory nor common practice.
“With different practices among member states and Notified Bodies existing with respect to the directive being referred to, certain CE markings could be unduly discriminated against. We therefore recommend that our members avoid referencing the 2007/47/EC Directive on the Declaration of conformity and request Notified Bodies to avoid making such reference on the Certificates,” says John Wilkinson, Chief Executive of Eucomed.
“After 21 March 2010, all CE marking on medical devices will imply that the device conforms to either 93/42/EEC or 90/385/EEC as amended by all subsequent relevant directives. If some certificates contain specific reference to 2007/47, this might suggest to users that some CE markings are “more equal” than others even though this is not the case,” Dario Pirovano, Consultant and Director of sectoral legislation at Eucomed stated.
For Post Market Surveillance purposes, conformity assessment documentation such as design dossiers, risk management files or audit reports should clearly refer to the modifications introduced by the revising directive.
Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €5.8 billion in R&D and employs near to 530,000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
Mark Grossien
Director Communications and External Affairs
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
