{"id":4515,"date":"2021-08-03T10:23:06","date_gmt":"2021-08-03T08:23:06","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-medical-devices-division-approved-for-the-accredia-surveillance\/"},"modified":"2026-01-28T13:05:10","modified_gmt":"2026-01-28T12:05:10","slug":"ecm-medical-devices-division-approved-for-the-accredia-surveillance","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-medical-devices-division-approved-for-the-accredia-surveillance\/","title":{"rendered":"ECM Medical Devices Division approved for the Accredia Surveillance"},"content":{"rendered":"\n

Ente Certificazione Macchine – Medical Devices Division – has successfully passed the surveillance visit conducted by Accredia auditors for Directive 1993\/42\/EEC.<\/em><\/strong><\/h2>\n\n

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

Last July ECM faced the periodic surveillance visit by Accredia<\/a><\/em> inspectors for the ISO\/IEC 17065 product scheme within the scope of the Medical Devices Directive 93\/42\/EEC (MDD)<\/strong>.<\/p>\n\n

The Accredia auditors verified the maintenance of the requirements<\/strong> of competence, independence and impartiality and the regular compliance<\/strong> 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 <\/u><\/strong>Notified Body for the Directive 93\/42\/EEC<\/a><\/u><\/strong>!<\/u><\/strong><\/p>\n\n

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<\/a> of MDR 2017\/745.<\/p>\n\n

<\/div>\n\n

ECM’S ROAD TO THE MDR<\/strong><\/h3>\n\n

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

We hope to be back after the summer break with one more accreditation!<\/p>\n\n

<\/div>\n\n
\n

<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"

Ente Certificazione Macchine – Medical Devices Division – has successfully passed the surveillance visit conducted…<\/p>\n","protected":false},"author":2,"featured_media":4511,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[316,414,636,416,128,436,415],"class_list":["post-4515","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-accredia-en","tag-audit-en","tag-direttiva-93-42-cee-en","tag-iso-17065-en","tag-mdr-2017-745-en","tag-organismo-notificato-1282-en","tag-sorveglianza-en"],"acf":[],"yoast_head":"\nECM Medical Devices Division approved for the Accredia Surveillance - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"Ente Certificazione Macchine - Medical Devices Division - has successfully passed the surveillance visit conducted by Accredia auditors for Directive 1993\/42\/EEC.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.entecerma.it\/en\/ecm-medical-devices-division-approved-for-the-accredia-surveillance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ECM Medical Devices Division approved for the Accredia Surveillance - 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