Medical device manufacturer MEIKO already MDR certified

MEIKO is thrilled to announce that the company has successfully made the transition from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The company manufactures washer-disinfectors for care utensils and is ahead of the game as the general deadline for making the switch is 31 December 2028.

This new certification means that MEIKO customers and partners can continue to be confident that their washer-disinfectors will comply with the latest regulations and offer the highest standard of quality, even into the future. ‘This MDR certification is one of the first to be awarded in our field. It is evidence of the speed with which we can adapt to new regulations and continue to bring safe, high-quality products to market,’ says Ingo Wiegand, Head of Product Compliance Management at MEIKO. 

The new MDR came into force within the European Union on 26 May 2021 and represents a comprehensive reform of the medical device industry, primarily affecting the manufacturers. The regulation requires testing and certification of all new and existing products. It replaces the previous MDD with the aim of making medical devices even safer across their full lifecycle. The most significant changes include further-reaching fundamental safety and performance requirements, stricter oversight, improved product traceability, and reinforcement of the requirements for clinical assessments and post market surveillance. 

‘The successful move to MDR certification is a significant milestone for us in gaining approval for our washer-disinfectors in the EU and bringing them to that market,’ says Dr Thomas Peukert, CEO of the MEIKO Group. ‘It also highlights our commitment to the safety and effectiveness of our products. Even into the future, Meiko will continue to be guided by the highest quality, safety and compliance standards.’