The European Commission has issued guidance on the implementation of Directive 2007/47/EC (“2007/47”) amending Directive 90/385/EEC and Directive 93/42/EEC which comes into force on 21 March 2010.
The 2007/47 was to be implemented in member states by December 2008, and it must be applied from 21 March 2010. However 2007/47 does not afford a transition period during which products could still be placed on the market or put into service in accordance with the previous regime. This has caused uncertainty in particular as the status of the devices approved under current requirements when 2007/47 is implemented and the validity of certificates issued prior to 21 March and the guidance seeks to address this.
The guidance confirms that in the absence of transitional provisions, medical devices placed on the market or put into service after 21 March 2010 must conform to the new requirements. It highlights that "placing on the market" or "putting into service" specific product and not to a type of device.
However certificates issued will remain valid after 21 March if they refer to devices already placed on the market or put into service prior to that date devices lawfully placed on the market or put into service prior to 21 March 2010 and consequently devices can continue to be marketed and used after that date. However manufacturers should ensure compliance with the new requirements as soon as possible and any audits by Notified Bodies (NB) and any award or renewal of a certificate by a NB after 21 March must factor in the new evaluation requirements.
Comment – It should be remembered that the interpretative document is not legally binding and that it is only the European Court of Justice that can rule definitive on the interpretation of 2007/47 although such guidance will in practice be considered authoritative and will inform any ECJ decision making. The interpretation guidance can be found at: http://ec.europa.eu/enterprise/sectors/medical-devices/files/guide-stds-directives/transitionalperiod_2007-47-ec_guidance_final_en.pdf