With the 26 of May around the corner, and as response to the call from the Council of the EU (EPSCO), the MDCG (Medical Device Coordination Group) has issued a document stating the challenging joint responsibility Member States and the Commission have, together with the concerned stakeholders, to ensure that the new legislation on medical devices is operational from the aforesaid date.
With the May 26th deadline approaching, learn more about the compliance path for medical devices under EU Medical Device Regulation 2017/745.
Brexit negotiations are on hold. EU trade talks could be postponed due to the coronavirus. But the new UK law on Medical Devices has been progressing.
In the context of Covid-19 global outbreak, the European Commission (EC) published a Recommendation(EU) 2020/403 to the manufacturers, Notified Bodies and Competent Authorities on conformity assessment and market surveillance procedures to address the continuously increasing demand of PPE such as face masks, gloves, protective coveralls or eyewear protection and medical devices such as surgical masks, exploration gloves and some gowns on the EU market.
The Irish Medtech Association proposes two key priorities for the next government.
Guidance for medical device manufacturers on clinical investigation for product release on the UK market from the Medicines & Health Products Regulatory Agency.
In light of the rapid spread of COVID-19 (coronavirus) in Belgium, Obelis has implemented on March 2020, teleworking in order to minimize the potential health risk to our personnel. To ensure a smooth and efficient service, we kindly request you to schedule in advance any request for a conference call.
A brief explanation of the impact that Brexit will have upon medical devices during the transitional period, namely until the December 31, 2020.
On the 24th of April 2020, Regulation 2021/561 was adopted and published, delaying the MDR by 1 year to May 26th 2021;
But what did this mean for Medical Device manufacturers?
Our FREE Webinar was to find out and hear about the MDR DELAY EXPLAINED – we covered the impact on:
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