European Commission issues interpretation of Directive 2007/47/EC
The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC).
As you are probably aware, EU Directive 2007/47/EC modifies the Medical Devices and Active Implantable Medical Devices Directives, and must be applied starting 21 March 2010. The European Commission guidance indicates that on 21 March 2010 medical devices placed on the market at that time must comply with Directive 2007/47/EC. This clarifies a point that was not clear in Directive 2007/47/EC. (2007/47/EC does not amend the In Vitro Diagnostic Devices Directive IVDD 98/79/EC.)
The newly published guidance document discusses five topics:
- Compliance of medical devices with the new requirements;
- Evaluation by Notified Bodies according to the new requirements;
- Certificates issued prior to 21 March 2010;
- Consultation of authorities responsible for pharmaceuticals; and,
- Overlap with the Machinery Directive.
After 21 March 2010, medical devices placed on the European market or put into service, must conform with the (new) requirements of the revised directives. This is applicable to each individual device. The terms “placing on the market” and “putting into service” are defined in the directives. Further, products already lawfully on the market or put into service prior to 21 March 2010 can continue to be marketed. (As an example, an ultrasound machine at a facility in The Netherlands placed there prior to 21 March 2010 can remain there.)
Compliance before 21 March 2010, is voluntary. However, if a manufacturer’s devices are compliant before that deadline, the Declaration of Conformity for the medical device should document the compliance with the Directive and include the text: “as amended by Directive 2007/47/EC.” And, if a Notified Body is involved in issuing the CE Marking for the medical device, the Notified Body must have verified compliance with Directive 2007/47/EC, before the Declaration of Conformity reflects compliance with Directive 2007/47/EC.
To reiterate, by 21 March 2010, manufacturers’ devices must be compliant with the modified Directive (Directive 2007/47/EC). Declarations of Conformity issued after 21 March 2010 are presumed to be compliant to the MDD and AIMDD as amended. And, any Notified Body assessments (renewal or delivery) which occur after 21 March 2010 must consider the (new) requirements of the revised directives. Medical devices whose classification was modified as a result of Directive 2007/47/EC (see changes to Annex IX, Classification Criteria MDD 93/42/EEC) must have obtained a new certification if it is placed on the market or put into service after 21 March 2010.
Beginning on 21 March 2010, Notified Bodies can no longer issue unlimited CE marking certificates (MDD 93/42/EEC Annexes V and VI plus AIMDD 90/385/EEC Annex V) which will be limited to a maximum of five years. Also, prior to 21 March 2010, existing unlimited certificates need to be reissued with a limited validity that has considered Directive 2007/47/EC.
If your conformity assessment involved a Notified Body, we would strongly recommend that you discuss the status of your current CE marking certificates and the provisions of Directive 2007/47/EC and this document with your Notified Body.