Phase 2 of the emergency has meant the restart of activities for many companies after the lockdown period imposed to contain the spread of the Covid-19 virus. Ente Certificazione Macchine, which in the last few weeks has given priority to medical devices services, has now regularly re-started the activities of all its operating divisions.

The Medical Devices Division continued to work non-stop throughout the lockdown on conformity assessment activities in accordance with Directive 93/42/EEC, with the aim of providing the market with the necessary services to deal with the coronavirus emergency. In order to bring its contribution, ECM has in fact decided to give priority to the certification requests of all those devices useful to face the crisis, including masks, gloves, filters for automatic respirators, accessories used in intensive care and many others.  In addition, thanks to the one-year delay of the application of the new MDR 2017/745 – for which ECM is currently carrying out the accreditation process – the European Commission has enabled the medical industry and conformity assessment bodies to concentrate all their energies on supplying the market with vital devices.

Now, with the arrival of Phase 2, ECM has resumed its activities at 360-degree. Our technicians from the Laboratory & Industry Division are operative to carry out testing and verification activities on machinery, products and work equipment both remotely and on site, with all the necessary precautions required by law to ensure the maximum safety. At the same time, the Academy Division is also structured to provide online training activities, in order to guarantee the continuity of its training service without risks for participants.

Moreover, we are also always at the disposal of market surveillance authorities, with whom we collaborate providing direct support in verifying the authenticity of the certificates attesting the conformity of products, in order to ensure that the products are placed on the market with the appropriate certifications and meet the safety standards required by regulations.

For information about our services, please contact us at:
Paolo Bernardoni – ECM Sales Manager paolo@entecerma.it | mob. +39 345 9938661
Antonio Balassone – Medical Devices Sales Manager antonio@entecerma.it | cell. +39 393 2471040