Category Archives: News

EC POSTPONES THE APPLICATION OF MDR BY ONE YEAR

On Friday 3 April the European Commission has adopted a proposal amending Regulation (EU) 2017/745 on medical devices as regards the...

REPORT OF IMPROPER USE OF OUR NOTIFIED BODY NO.1282

As an example, in the image you can see an improper use of our Notified...

OFFICIAL COMMUNICATION ON FAKE CERTIFICATES OF MEDICAL DEVICES

Following the several reports that we are receiving regarding the circulation of forged certificates attributable...

WARNING! CLARIFICATION ON FAKE AND/OR INVALID CERTIFICATES

As previously reported, we are receiving several notifications about documents attributable to our Company (in...

EUROPEAN COMMISSION PLANS TO POSTPONE THE IMPLEMENTATION OF THE MDR

Considering the recent declaration by the European Commissioner for Health and Food Safety, it is expected that...

​WARNING! FAKE CERTIFICATES

WARNING! ECM has been notified that several manufacturers are selling medical face masks, PPE and in...

COVID-19 OUTBREAK AND SUPPLY OF PPE AND MEDICAL DEVICES.

With the aim to ensure availability of PPE and medical devices for adequate protection in...

FROM CHINA 2000 MASKS FOR VALSAMOGGIA

The People’s Republic of China has decided to donate 2,000 masks to Ente Certificazione Macchine, Notified Body located...

WARNING! OFFICIAL COMMUNICATION – NOTIFICATIONS OF FORGED AND/OR INVALID CERTIFICATES

In the last few weeks, we have received a large number of notifications about the...

ECM ENGAGED TO FIGHT THE EFFECTS OF CORONAVIRUS

Also Ente Certificazione Macchine, European Notified Body for the certification of medical devices, is implementing its resources and...