Successfully passed by our Medical Devices Division, the inspection visit by the Italian Ministry of Health and Accredia, according to the MDR Regulation and the MDD Directive.

Recently, the ECM Medical Devices Division received the inspection visit from the Italian Ministry of Health and Accredia. This important audit was conducted according to Regulation (EU) 2017/745 and Directive 93/42/EEC, in order to assess our ability to operate as a Notified Body.

CONFIRMATION OF NOTIFICATION

We are thrilled to confirm that ECM successfully passed the inspection! Thanks to this result, we have achieved the re-confirmation of our designation as Notified Body No. 1282 to operate in accordance with the European Medical Device Regulation 2017/745 (MDR). This notification allows us to continue providing conformity assessment services for the issuance of EU certification for medical devices intended for the EU market.

AUTHORIZATION AND SURVEILLANCE

Furthermore, also our authorisation to operate under the Medical Device Directive 93/42/EEC (MDD) was reconfirmed, allowing us to carry out the required surveillance activities to verify the validity of certificates during the transitional period (for legacy devices).

For more details on our accreditations and the full list of devices within our scope, please visit the European Commission’s Nando Information System database.

“Thanks to the technical and regulatory expertise of our team, we are proud to have achieved these important milestones,” explains our CEO Luca Bedonni “the accreditations attest to our professionalism and confirm our role as a reference body for the certification of medical devices within the EU market.”

For more information about our services or to contact our team, please send an email to our Sales Manager Diego Stevanella at diego.s@entecerma.it