27 March 2020

Considering the recent declaration by the European Commissioner for Health and Food Safety, it is expected that the European Commission will propose to postpone the implementation of the Medical Devices Regulation (MDR) by one year.

MDR 2017/745 should have been applied from 26 May, however, the current crisis due to the COVID-19 outbreak requires the industry to concentrate its efforts to deal with the emergency.

MedTech Europe – the European association representing the medical technology industries – had in recent days officially called for a pause in the implementation of IVDR and MDR to facilitate the fight against COVID-19.
Companies are working non-stop to preserve health systems and ensure the constant supply of ppe and medical devices necessary to contain the spread of contagion, as well as all other medical technologies needed every day to diagnose, treat and monitor patients affected by coronavirus and other critical or chronic health conditions. It is therefore essential that all actors involved focus their efforts to face the current crisis, postponing the implementation of the new MDR and IVDR regulations until the COVID-19 emergency is over.

Also Ente Certificazione Macchine, Notified Body for the Medical Devices Directive 93/42/EEC and applicant for MDR accreditation, is fully dedicating its resources and efforts to perform the conformity verification activities of masks, gloves and other medical devices necessary to face the coronavirus emergency. We therefore join the industry’s call, knowing that the priority is to provide the market with everything it needs to overcome the current crisis.

For information on our services >> Antonio Balassone | mob: +39 393 2471040
To verify certificates >> Paolo Bernardoni | mob: +39 345 9938661 | office: +39 051 6705141