CPME Rapporteur: Dr Katrín FJELDSTED (IS)
CPME Secretariat: Mr Markus KUJAWA

Strict surveillance and tight controls over medical devices is of utmost importance according to CPME’s policy and mission of patient safety and high quality healthcare. Following the discovery of fraudulently manufactured and sub-standard medical devices, CPME believes that action must be taken and it will closely follow and monitor the legislative developments at European level.

CPME contributed to the negotiations of the new Medical Device Regulations which were adopted by the European Parliament and the Council in April 2017.

Adopted policies include:

• CPME Suggested Ammendments on Medical Devices and In Vitro Medical Devices, March 2013
• CPME statement on Medical Devices and In Vitro Diagnostics Medical Devices, February 2013
• CPME calls for increased surveillance of medical devices, May 2012
• CPME Comments to the Revision of directive 98/79/EC on In Vitro Diagnosis Medical Devices, September 2010
• Joint Declaration of CPME – Eucomed on cooperation between physicians and the medical technology industry, June 2007
• Reprocessing of single use medical devices, September 2004
• Manifesto : Calls for EU action to regulate the reprocessing of single use medical devices in order to protect the health and safety of patients and healthcare workers, September 2002