Medical Devices Directive 93/42/EEC

NOTICE: Intertek Semko AB, NB 0413, have been made aware of a number of manufacturers selling medical surgical/face masks falsely claiming to be certified by Intertek. Intertek have seen false ‘certificates’ on letterheads, or the use of Intertek’s logo and/or name and Notified body number 0413, as the basis for CE marking against the Medical Device Directive or Personal Protective Equipment Directive. Intertek SEMKO AB, NB 0413, is not registered under the PPE directive in NANDO. These false ‘certificates’ have no legal value and cannot be used as proof of conformity assessment.

In case of doubt, we recommend that you verify the authenticity of the certificate by contacting Intertek’s Medtech team at medtechsweden@intertek.com. We will review the certificate and respond to your request as soon as possible. We are continuously monitoring these false certificates and reporting them accordingly to the Competent Authorities.

Intertek Semko AB is no longer taking applications for MDD due to the Date of Application of MDR with May 26th 2021.

The Medical Device Regulation (MDR) (2017/745) will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on Active Implantable Medical Devices (90/385/EEC).

Intertek Medical Notified body does not provide consulting services. Any consulting activities provided by Intertek Group are separate and independent from certification activities of the Notified Body.