ECM Medical Devices Division, moving closer to the designation for the MDR regulation, intensifies its international institutional commitments in the regulatory field.

While waiting for the accreditation for the Regulation (EU) 2017/745, in the last days we have been invited to attend the 66th NBCG-MED meeting and the Ordinary General Assembly of Team-NB.

66TH COORDINATION MEETING OF NOTIFIED BODIES FOR MEDICAL DEVICES

From 5 to 7 April 2022, the European Notified Bodies for medical devices met with authorities and industry groups to discuss the main regulatory issues.

Among the topics covered:

• The capacity of Notified Bodies, following the application of Regulation (EU) 2017/745;
• The definition of a harmonised approach to the guidances produced by the European authority;
• In-depth examination of “hybrid audits” (onsite and offsite).

The debate with institutional authorities provided a particularly rich experience. Among the shared issues were the situation regarding Annex XVI of the MDR and the progress of the designations of notified bodies.

ORDINARY GENERAL ASSEMBLY MEETING OF TEAM-NB

The General Assembly of Team-NB, the European Association of Notified Bodies for medical devices, is an important opportunity for dialogue and updating among certification bodies. Through the exchange of opinions and experiences, notified bodies address major regulatory issues and identify shared lines of interpretation.

Ente Certificazione Macchine regularly participates in these and other institutional meetings, cooperating with the main actors of the European regulatory and normative landscape. Through its participation, ECM enhances the prestige and know-how of its staff, providing medical device companies around the world with a highly professional and recognised service.

For further information on our services in the medical device field, please contact our Sales Manager Ing. Diego Stevanella at diego.s@entecerma.it | cell. (+39) 393 2471040.