Last week ECM travelled to Brussels to attend the 61st meeting of Notified Bodies for Medical Devices. As Notified Body according to MDD 93/42/EC, ECM is invited to join these important events, occasion of discussion between the NBs. The aim of these periodic meetings is to get new information on the regulatory framework and share their contribution based on the direct experience and technical expertise of the participants.

Last October 9-10, our Technical Manager Tatiana Vignudelli attended the meeting, which covered many topics related to the new MDR 2017/745, including:

• > definition of the sampling criteria of the technical documentation;
• > presentation of the CND nomenclature (the Italian national classification of medical devices) which will be adopted at European level as EMDN (European Medical Devices Nomeclature);
• > focus and discussion on Articles 16 and 17 of the EU Regulation 2017/745.

ECM is working hard to complete the necessary activities for the designation as Notified Body under the new MDR. In addition to the certification activity according to the MDD, ECM strives keep up to date on the regulatory news, in order to increase and improve its skills and services.

We would like to recall that Regulation (EU) 2017/745 will be applicable from 26 May 2020, so we encourage manufacturers to take action to prepare for the significant changes that will soon effect the medical device world.
Starting from January, ECM will organize a cycle of meetings with stakeholders focused on the MDR and the challenges ahead.

For more information, please contact us at info@entecerma.it or contact our Sales Manager Antonio Balassone at antonio@entecerma.it | mob. +39 3932471040