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.
Cannabidiol (CBD) has been capturing more and more the attention of manufacturers and consumers in many different consumer products, particularly in food supplements in view of its multiple and alleged beneficial properties for human health. CBD is a non-psychoactive compound and one of the many cannabinoids contained in Cannabis.
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:
Obelis Academy held the webinar MDR Delay: what has changed on May 27th, 2020. Bottom line: 1-year delay provides you with additional time to finalize your compliance with the MDR, which was a complex and lengthy process!
So which actions do Manufacturers have to take to be MDR COMPLIANT for the EU market?
Read more about it here.
Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. Read more about it here.
As squishy and slime toys are becoming increasingly popular among children, many EU member states have been strengthening inspections for harmful chemicals in their composition.
The second corrigendum to Regulation (EU) 2017/745 on medical devices has brought a change in the wording of certain part of articles 78(8), 120(3), 120(4), 120(8) and 122; but what does it imply for the concerned economic operators?
The new Regulation sets out an obligation for economic operators to cooperate with the market surveillance authorities and establishes a framework for the control of products entering the Union market.
The Medical Devices Coordination Group (MDCG) has published a document on the validity of certificates issued in accordance to the Directive after the new Medical Device Regulation (MDR) becomes applicable.