Healthium Medtech receives CE certification under the EU MDR norms for class III implants 

The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards

Healthium Medtech, medical devices company focused on surgical, post-surgical and chronic care has announced that the company 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.

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.