Category Archives: News

Official communication: improper use on Declaration of Conformity

Ente Certificazione Macchine reports the improper use of its name on the Declaration of conformity...

Artificial Intelligence: on the way to a European regulation

With the Commission’s proposal for a regulation, Europe establishes a common position on the rules...

Official communication: false EC Declaration of Conformity

We have been informed about the circulation of a false EC Declaration of Conformity that...

The impact of the new MDR Regulation on the medical device industry

The European regulatory scenario is changing rapidly due to the implementation of the new EU...

Simone Farinelli is the new General Manager of Ente Certificazione Macchine USA Corp

Ente Certificazione Macchine USA Corp, the U.S. branch of ECM, announces the hiring of Simone...

Meet ECM at ARAB HEALTH 2023

From 30 January to 2 February ECM will be in Dubai at Arab Health 2023...

Report of improper use of notified body number 1282

Ente Certificazione Macchine reports the improper use of the notified body number 1282 on the...

MDR and IVDR amendment proposal: what’s new

In the last days, the EU Commission has presented a proposal for a Regulation amending...

ECM issues the first MDR certificate for the company Withings

Withings, leading manufacturer of connected health devices, including scales, hybrid watches, sleep and blood pressure...

Christmas 2022 – closing offices

On the occasion of the Christmas Holidays, the ECM offices will be closed from 24...