From: Peter Meeds [mailto:[email protected]] Sent: Saturday, September 24, 2011 9:05 AM To: MARKT PQ EVALUATION; [email protected]; [email protected] Subject: RE: Directive 2005/36/ec and its relationship to the Medical Devices Directive 93/42/ec

Thankyou for your prompt response. The International Federation would like to submit a response by email, but given the importance of this issue the International Federation of Denturists (IFD) would like to send a delegation to meet Mr.Tiedje in due course. Should partial access to the profession of Dentistry be blocked, based on incomplete information from the Council Of European Dentists (CED) and similar recomendations from UEAPME, there is potential for missaplication of EU law and the free movement of professionals within the EU. As mentioned in my previous email; CED represents over 300,000 Dentists across the EU and UEAPME an affiliate of FEPPD, represent the interests of Dental Laboratories within the EU - Denturists/Clinical Dental Technicians compete with both groups in the provision of dentures to EU citizens. Clearly adopting a restrictive practice could leave the commission open to challenge and would not be in the wider interests of EU citizens for the services provided by Denturists/Clinical Dental Technicians. We also believe the Medical Devices Directive (93/42/EEC) further supports the independence of this profession and will provide greater clarity in due course, the International Federation of Denturists has a meeting in Holland between the 5th and 8TH October, where these issues are to be discussed and a response formulated. Although I understand the consultation for Directive 2005/36/EC has closed, it would be sensible to delay any amendments, relating to partial access to the profession of Dentistry, until the commission has the benefit of consultation with the International Federation of Denturists and sought legal advice.

For Reference, I enclose a legal opinion from 2003, based on the provision of dentures to members of the public by an interantionally qualified Denturist/clinical dental technician in the UK, this clarifies that Medical Devices Directive (93/42/EEC) and its supporting written prescription, allow for independent practice across the EU. I also enclose a more recent response from a UK based dental indemnifier confirming that clinical dental technicians can write/issue a written medical device prescription.

For reference I again also enclose a link to the Office of Fair Trading and there current market study of Dentistry inthe UK: http://www.oft.gov.uk/news-and-updates/press/2011/99-11

Kind Regards,

------Peter Meeds Rdt Dip Cdt RCS (Eng) www.burnsidedental.com

Clinical Dental Technician Dental Technician

Burnside Dental Studio 3a The Crescent Eaton Socon Cambridgeshire PE19 8Hf UK Work: +44 (0)1480 210950 Mobile: +44 (0)7505 602783