Updates from the Medicines and Healthcare Products Regulatory Agency on the withdrawal of several UK-based notified bodies.
Medical devices and healthcare auto
Joint implementation plan on the new Medical Devices Regulation – (EU) 2017/745 (MDR)
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.
The latest news on the approval process of the UK Medical Device law
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.
COVID-19 outbreak: The European Commission proposes faster access of PPE and medical devices to the EU market
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.
Irish MedTech Priorities for the Next Government
The Irish Medtech Association proposes two key priorities for the next government.
MHRA guidance for manufacturers on Clinical investigations of medical devices
Guidance for medical device manufacturers on clinical investigation for product release on the UK market from the Medicines & Health Products Regulatory Agency.
What are the implications of Brexit for Medical Device Companies up to December 31, 2020?
A brief explanation of the impact that Brexit will have upon medical devices during the transitional period, namely until the December 31, 2020.
MDR DELAY: Do you understand the implications of this delay?
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:
Seminar on ISRAEL & EU Regulations of Cosmeticsand Medical Devices
Interested in other webinars? Let us know!
COVID-19 FREE IVD WEBINAR: How to register IVD test kits in Europe?
Due to the outbreak of the Covid-19 in Europe, the European Union was registering increasing shortages of test kits and IVD-related devices.
Our FREE Webinar was to find out and hear about how to register IVDs in Europe.