26 mei 2021
Nemo Healthcare achieved official MDR Certification today!
Veldhoven, The Netherlands – 26 May 2021
The European Union’s (EU) Medical Device Directive (MDD) has no longer been valid since 26 May 2021. This was replaced by the EU Medical Device Regulation (MDR), the new regulatory framework that applies to all Medical Devices marketed in the EU.
Supervised by the Notified Body DARE!! based in Woerden, The Netherlands, Nemo Healthcare has worked hard to obtain this new certification, which is needed to continue the successful and safe roll-out of the Nemo Fetal Monitoring Solution.
‘Operating according to the latest standards is in Nemo Healthcare’s DNA. This ensures that our clients and their patients benefit from safe and interference-free (EMC) medical equipment and devices. Working with DARE!! to achieve this goal illustrates the professional working relationship we have had with DARE!! in recent years,’ stated Michiel Manuel, Nemo Healthcare CEO.
In 2017 the European Union announced that it was time for a revision of directives:
‘a fundamental revision of the directives is needed to establish a robust, transparent, predicable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.’
European Commission - 5 April 2017
Nemo Healthcare started exploring the consequences and benefits of the new MDR in 2017, which ultimately resulted in Nemo Healthcare becoming one of the first Medical Device companies in the Netherlands to obtain certification.
‘Our new NFMS (Nemo Fetal Monitoring System) plays an important role in the safety and comfort of births in Europe and beyond. Being at the finish-line so far ahead of the deadline helps us focus on our mission; safe births, healthy children,’ stated Will Ickenroth, VP Business Development, Marketing & Sales.
For more information please contact:
Will Ickenroth, firstname.lastname@example.org