CE marking on Surgical Instruments – what should you be looking for?

The recent Panorama programme on surgical instruments highlighted the fact that to achieve the CE mark, you can effectively self-certificate. By registering in the UK with the MHRA, you can be given a registration number and start CE marking. When purchasing from companies who CE mark their instruments, they should still have a series of technical documents, known as technical files, should they be required by the MHRA.

Without these documents, the necessary steps have not been taken
to ensure the instruments are safe to go on the market. As a basic, each device
should have:

• a technical file – which specifies its
  description, the justification for the instruments being Class I
• Product list with reference to technical
  descriptions
• Essential requirements checklist completed
  against 93/42/EEC
• Risk analysis that complies with 14971: 2007
• Copies of product labels that comply with BS
  EN 980
• Relevant instruction for use for cleaning
• Declaration of Conformity

If a medical device has not addressed the Essential Requirements,
it is not fit to go on the market. It may be an idea for ask to see the above
documents, or ask if they are available. Most companies will be happy to
provide this information.