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 (2017/745)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.
MDR Date of Application Postponed for 1 Year
The European Commission (EC) proposal to postpone the Date of Application of the Medical Device Regulation (MDR) for one year was published in the Official Journal 24.April.2020. The decision to postpone the MDR date of application was due to the potential impact on the MDR implementation due to the extraordinary circumstances associated with the COVID-19 pandemic.This adoption will, in short, postpone almost all the transitional provisions by 26.May.2021 which, originally, was set on the date of 26.May.2020. Following the decision of the MDR postponement, all the MDD activities will remain unchanged and notified bodies may continue normal work for additional one year.
Intertek SEMKO AB, NB 0413, are now able to continue the work with planned MDD certification renewals, to obtain applications for early renewals and to extend our deadline for assessing significant changes of MDD products.
Regardless of the delay of the MDR date of application we recommend our clients to maintain the current focus to continue the work with the MDR implementation as the new date of application for 26.May.2021 will approach quickly.
If interested in applying for initial MDD certification, or for any other inquiries please contact: medtechsweden@intertek.com.
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SUMMARY OF KEY REQUIREMENTS FOR PLACING A DEVICE ON THE GREAT BRITAIN MARKET FROM 1 JANUARY 2021
View the Summary of Key RequirementsProcess for Changes in Certification Status
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