What does the CE mark mean? Click image

Issues have been raised regarding the use of CE marked materials and components by companies directly contacting trust hospital supplies and finance departments.

Having sought and received formal clarification from the Medicines and Healthcare Products Regulatory Agency (MHRA), please note the following;

• Wherever possible, CE marked materials and components should be used for the construction of a custom-made medical device.
• If no CE marked material or component is available, ensure the decision to use an alternative can be supported with evidence (document this).
• With regard to an adverse incident, the MHRA can only provide guidance - a definitive statement of law can only be given by the Courts.
• The MHRA has an Adverse Incident Centre (AIC) to manage reports of device failure and safety issues.
  

With regard to the above, I make three recommendations to any individual responsible for the manufacture and supply of custom made medical devices from their laboratory:

1. Ensure your service and staff comply with EU directive 93/42/EEC and you are (RG2) registered with the MHRA.
2. Use CE marked materials and components wherever possible.
3. Whatever choices you make, regarding manufacture and supply of custom-made devices, be prepared to defend your decisions as they may (ultimately) be tested in Court.
   

If you require further information please access the MHRA website: www.mhra.gov.uk

MB Cutler FIMPT GCGI
IMPT Project Lead – Statutory Registration