Ente Certificazione Macchine – Medical Devices Division – has successfully passed the surveillance visit conducted by Accredia auditors for Directive 1993/42/EEC.

As Notified Body no. 1282, ECM is authorised to carry out conformity assessments and issue product certifications according to ISO/IEC 17065 standard for several European product directives.

Last July ECM faced the periodic surveillance visit by Accredia inspectors for the ISO/IEC 17065 product scheme within the scope of the Medical Devices Directive 93/42/EEC (MDD).

The Accredia auditors verified the maintenance of the requirements of competence, independence and impartiality and the regular compliance with the applicable regulations. Our staff and our activities in the medical device area have been confirmed and we can therefore continue to operate as a Notified Body for the Directive 93/42/EEC!

With the implementation of the new MDR 2017/745, as of 26 May 2021 the Notified Body is no longer able to issue new certificates under MDD 93/42/EEC. However, we are authorised to carry out surveillance activities for the validity of certificates issued under the Directive during the transitional period, as set out in Article 120 of MDR 2017/745.

ECM’S ROAD TO THE MDR

ECM has been carrying out for a long time the complex and long pathway towards accreditation under the Regulation (EU) 2017/745. We have now reached the final stage of the designation process and are hopefully awaiting the last communications from the competent bodies.

We hope to be back after the summer break with one more accreditation!

For more information on our activities, please contact our Sales Manager Paolo Bernardoni – paolo@entecerma.it | cell. (+39) 345 9938661