The medical device industry associations in Europe and the US believe that companies in the sector are not yet sufficiently prepared for the entry into force of the new Medical Devices Regulation. They have therefore called on the European Commission to grant a moratorium in order to allow time to adapt to the new regulation.
The new Regulation 745/2017 on Medical Devices It will come into force next May – in just over 50 days’ time – across the entire EU market. This means that, over the past few months, medical device companies should have made the necessary changes to comply with the new legislation.
From technical and health consultancy firms and offices of regulatory affairs As specialists in medical devices, we have been highlighting the need to adapt to the new regulations for years. These new challenges have also been communicated through professional associations and bodies. In fact, throughout 2020 we have taken part in training sessions organised by industry bodies – such as the employers’ association FENIN o Beauty Cluster Barcelona– to raise awareness of the changes that need to be made.
However, it would appear that many companies in the healthcare products sector – including beauty salons and equipment suppliers – have not yet been able to make the necessary changes. Or so the employers’ organisations claim AESGP (EU) y Medtech (US) to call on the European Commission to impose a moratorium on the implementation of the new Regulation.
Whether or not the moratorium requested by AESGP and Medtech is granted… Take action and transform your project!
We do not yet know whether the European Commission will heed this request for a moratorium put forward by the employers’ organisations AESGP and Medtech. But we do know what your company needs to comply with the Medical Devices Regulation 2017/745. And we can certainly help ensure that your medical devices company – whether you’re a manufacturer, distributor, beauty salon or similar – meets these requirements. Here you’ll find more information about our regulatory services for medical devices.
Our proposal? Solutions!
Tick-tock, tick-tock… Is your company ready for the entry into force of the new Medical Devices Regulation (2017/745)?
At the end of 2019, we set up a counter to track the exact date on which the new Medical Devices Regulation came into force. At the time of writing this post, the following were still outstanding:
