The EU has adopted the Medical Device Regulation, which replaces the Medical Devices Directive.
The Medical Device Regulation (2017/745)
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).
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 Business Assurance does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separated and independent from testing and certification activities and undergo a regular detailed risk analysis to ensure impartiality is maintained.
