Our Medical Devices Division team is fully committed to conformity assessment activities under the MDR and continues to issue EU certificates required to keep medical devices on the market.

Ente Certificazione Macchine is non-stop carrying out EU conformity assessment activities as Notified Body No. 1282 for Regulation (EU) 2017/745. Thanks to the expertise of our assessors and the commitment of manufacturers to achieve full compliance of their medical devices, ECM proceeds ahead with the issuance of EU certificates in accordance with the MDR.

EM PHARMA COMPANY’S ACHIEVEMENT

We are pleased to announce that the prestigious company EM Pharma has obtained the EU certification in accordance with the European Medical Device Regulation (EU) 2017/745. The British company, a 20-year excellence in the manufacture and supply of eye, ear and nasal care products, has successfully completed the process of assessing compliance under MDR requirements and achieved the EU certification.

Specifically, the Class IIb device certified by ECM in accordance with Regulation (EU) 2017/745 is a sterile contact lens care solution, which from today can be placed on the European market in full compliance with current regulation.

“For us at ECM it is a pleasure and a honor working with such a prestigious company as EM Pharma, which has always been committed to provide the market with products that meet the highest quality standards” explains Eng. Diego Stevanella – Sales Manager of ECM.

In the current context of transition to the new regulatory regime, companies are called to promptly adapt to the requirements of MDR, while notified bodies must carry out the assessment activities with strictness and professionality. The issuance of EU certification is an important milestone for both the NB and the manufacturer, as it enables the entire medical sector to evolve by elevating product quality and safety in the EU market.

“In this scenario,” concludes Stevanella “the ECM team and the manufacturer EM Pharma worked with competence and proactivity, finalizing the complex certification process required by the MDR, which ended successfully for all parties involved”.

Would you like to obtain EU certification to market your medical devices in EU?

Contact us at Ing. Diego Stevanella diego.s@entecerma.it | tel. (+39) 393 2471040