As every year, Ente Certificazione Macchine reflects on the months just passed, in order to focus its efforts on the achievement of future goals.

For ECM, an eventful and highly satisfying year is ending. Thanks to the work and commitment of all the staff, Ente Certificazione Macchine has in fact consolidated its international prestige in 2023, confirming itself as the reference body for the European and overseas markets.

A YEAR OF INTERNATIONAL SUCCESS

With the support of our historical partner ECM Korea, in September 2023 ECM signed an important Memorandum of Understanding with KTC (Korea Testing Certification institute), leading testing and certification agency in South Korea. In front of a large audience of international and local institutional figures, as well as representatives from the business and academic worlds, KTC President Sung-il Ahn and Luca Bedonni – Sole Director of ECM, signed the MoU that officially launched the collaboration between the two bodies on safety and conformity assessment of products, machinery and medical devices destined for the European and Korean markets.

Moreover, on the Asia-Pacific Region, through our consolidated partner ECM APAC, ECM presented its services at CMEF Shanghai, the International Medical Equipment Exhibition, and at CIIF 2023 – the International Industry Fair in China, collecting positive feedback and exploring new business opportunities.

UP TO DATE WITH REGULATORY NEWS

Always focused on regulatory news, ECM has invested in updating its resources and skills this year as well, in order to offer professional and state-of-the-art services. The publication of the Machinery Regulation (EU) 2023/1230 and the Regulation (EU) 2023/1542 on batteries introduce important novelties regarding the safety requirements to be met in order to place products and machinery on the EU market and in operation. To better face the transition to the new regulatory regime, ECM organised two webinars to discuss the new regulations with manufacturers, importers and professionals.

On the medical devices side, the adoption of Regulation (EU) 2023/607 of 15 March 2023 extended the period of validity of certificates issued on the basis of the previous Directives, but only under certain conditions. As Notified Body No. 1282 for the MDR regulation, ECM Medical Devices Division is carrying out its certification activities, constantly discussing with other international players on the main regulatory focuses. Last November, ECM attended MEDICA 2023, the main international medtech trade fair, enjoying great success among manufacturers and professionals with its certification services and expertise.

ACCREDITATIONS ACHIEVED

With the aim of providing companies with cutting-edge services in line with market needs, ECM obtained, from the Homologation Authority of the Republic of San Marino, the Qualification Certificate as EMC Laboratory to perform tests for vehicles, systems, components and technical entities for vehicles according to the ECE-R10 standard, becoming one of the few companies in Italy authorised to carry out the testing activities required for the purposes of issuing ECE-R10 homologation for the automotive sector.

In addition, the ECM Testing Laboratory achieved the Accreditation by Perry Johnson Laboratory Accreditation Inc. (PJLA) as Testing Laboratory No. 121697 accredited according to ISO/IEC 17025 standard.

Meanwhile, the ECM Product Division requested and received the extension of the scope of accreditation for the Product Scheme, according to ISO/IEC 17065 standard, for the Pressure Equipment Directive 2014/68/EU.

FUTURE GOALS

2024 is expected to be a busy year, during which we expect to achieve important goals. Among the new accreditation projects we are working on are drones, batteries and artificial intelligence.

Also regarding medical devices, our staff is working on expanding its scope, with the aim of further increasing the range of devices that ECM can certify.

Finally, ECM’s participation in working groups and institutional meetings organised at the European level will continue in 2024, in order to discuss and contribute to the regulatory scenario. Training activities for companies and professionals will also carry on: ECM’s Academy Division is already planning a rich calendar of webinars on the latest market focuses.

As every year, we would like to thank all our staff for their great daily work, but also our customers and collaborators, who continue to place their trust in our activities. We will keep on working with the commitment and professionalism that have always distinguished us in order to provide companies with ever more cutting-edge, quality services.

With the wish for a new year full of hope and happiness, ECM wishes everyone a Merry Christmas!