The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards
Healthium Medtech has received the new CE certification under the stringent EU MDR (European Union’s Medical Device Regulation). As a part of the regulation for CE certification, the EU MDR accreditation is mandatory for sales to European countries and several other regulated markets. The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards.
Healthium Medtech is India’s largest independent medical devices company in the surgical consumables market, the largest non-captive surgical needles manufacturer globally by volume and the third largest company overall in the urology collection devices market in the UK.
Healthium currently operates eight integrated and scaled manufacturing facilities, several of which have global accreditations and approvals including US FDA, TGA, CDSCO, EN ISO 13485:2016, ISO 9001:2015, CE under MDD and now CE under EU MDR.
The EU MDR necessitates more stringent measures versus the earlier CE norms under the European Union Medical Device Directive (EU MDD), keeping patient safety in mind. This means stricter compliance, increased vigilance, robust complaint handling, regular product and customer feedback procedures, and trend reporting requirements with periodic safety update reports. In addition, the UDI ID which will now be required on all devices will enhance traceability across the supply chain.
Speaking about the EU MDR accreditation, Anish Bafna, CEO and MD, Healthium Medtech said, “We are delighted to receive the CE certification under EU MDR. At Healthium, we strive toward achieving the highest safety and quality standards for better clinical outcomes. The certification is a testimony to our continuous commitment to operational excellence and our focus on delivering the same high-quality, safe, value-driven products not only to the EU but also to India and other countries. This is aligned with our vision of facilitating access to precision medtech for every patient, globally.”
Dr Ashok Moharana, Chief Medical Officer, Healthium Medtech further adds, “The CE certification under EU MDR reinforces our growing capabilities at Healthium towards innovation, safety, quality and clinical research for providing holistic solutions for clinicians and the patient community. EU MDR signifies a milestone for the medtech fraternity and supports our calibrated efforts to bring the highest safety and quality standards for improving patient outcomes across our key therapeutic areas. We will continue to rise the value chain by adhering to the highest standards in patient safety.”
