The Machinery Directive 2006/42/EC is a key piece of EU legislation that follows the ‘New approach‘ principles. Read about the new proposal to update this legislation.
Medical devices and healthcare auto
Webinar: EU Perspective on Medical Devices in 2021
Find out more information on the new requirements by MDR and BREXIT
Webinar: Classification rules under IVDR and Covid-19 derogation lists & database
The upcoming IVDR regulation will be fully applicable as of May 26, 2022. There will be changes in the IVDR landscape, and manufacturers must make sure to be compliant on time, in order to keep selling their devices on the European market.
Webinar: Complying with the MDR
The new medical Device Regulation is fully applicable as of May 26, 2021, therefore you need to know how to manage your Legacy Devices Compliance in the EU.
High-risk medical devices in Europe: new methods of evaluation through CORE-MD project
Discover the new methods of evaluation through CORE-MD project on high-risk medical devices in Europe.
FAMHP releases its Annual Report: Focus on medical devices
The digital Annual Report 2019 contains interesting figures concerning medicines and medical devices read more about it here.
Medical Device Industry: Switzerland becomes a “third country”
Read on the Swiss Federal Council unsigned Institutional Framework Agreement (InstA).
Class I Medical Devices: Achieve MDR compliance in 9 steps
The new factsheet published by the European Commission shows the necessary steps for compliance. Find out how to achieve MDR compliance in 9 steps.
New ISO standard on labelling for medical devices!
Find out some key characteristics for the new ISO Standard on labelling for medical devices. What does the new ISO 20417:2021 change? Read more here.
Medical Device Regulation and Artificial Intelligence: what future requirements?
The Special Committee on Artificial Intelligence in a Digital Age (AIDA), established by the European Parliament, has directed all its efforts in filling current regulatory gaps to develop a European framework on Artificial Intelligence (AIDA, 2021). Read more on the topic here.