Swabs: compliance verification

​​Certain tests for COVID-19 use nasal swabs. Swabs are medical devices that must have a CE mark and meet certain requirements. The FAMHP recommends verifying the conformity of swabs.

Several tests for the detection of COVID-19, in particular PCR and antigen tests, are carried out using a swab to take samples.
A swab is a class I medical device, in accordance with the provisions of Directive 93/42/EEC of 14 June 1993 and Regulation 2017/745 of 5 April 2017 on medical devices. It must therefore have a CE marking and comply with certain essential requirements.

Swabs are generally sold sterile. In this case, the CE marking must be accompanied by the four digits of the notified body that has verified the conformity of the device.

The FAMHP therefore recommends verifying the conformity of the swabs that are being used in COVID-19 detection tests.

How can you check the conformity of the swabs?

  1.  The following information must be mentioned on the package.

  • Name and address of the swab manufacturer.
    The name may be represented by the symbol

            

  • Name and address of the authorised representative if the manufacturer is based outside the European Union.

           Symbol used: 

  • Name of the device.
  • CE marking.

           

  • If the swab is sterile:
    - the method used to make the device sterile (for example: EO, Rx ...) or just the word “sterile”;

           or
         - the four digits of the notified body that can be checked in the European Nando (New Approach Notified and
           Designated Organisations) Information System: Directive 93/42/EEC or Regulation 2017/745.

          

   2.   Ask for the following documents.

  • The manufacturer's EU declaration of conformity.
  • For sterile swabs, the CE sterility certificate issued by a notified body competent for medical devices under Directive 93/42/EEC or Regulation 2017/745.
    This certificate should not be mistaken for the ISO certificate.

Contact
meddev@fagg-afmps.be

Last updated on 10/02/2021