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 May 2017. The European Commission’s factsheet for healthcare professionals on the new Regulations can be found in all EU languages here.
Adopted policies include:
- Joint Statement on the Implementation of the new Medical Device Regulations, 2019
- CPME Suggested Ammendments on Medical Devices and In Vitro Medical Devices, 2013
- CPME statement on Medical Devices and In Vitro Diagnostics Medical Devices, 2013
- CPME calls for increased surveillance of medical devices, 2012
- CPME Comments to the Revision of directive 98/79/EC on In Vitro Diagnosis Medical Devices, 2010
- Joint Declaration of CPME – Eucomed on cooperation between physicians and the medical technology industry, 2007
- Reprocessing of single use medical devices, 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, 2002
