The digital Annual Report 2019 contains interesting figures concerning medicines and medical devices read more about it here.
Medical devices and healthcare auto
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.
Call for data on ingredients with potential endocrine-disrupting properties used in cosmetic products
Starting from February 15th, 2021, the European Commission launched a call for any interested parties to submit scientific information related to some cosmetic ingredients that may have potential endocrine-disrupting properties. Once the consultation period will be over, the European Commission will request an opinion to the EU Scientific Committee on Consumer Safety (SCCS) on this topic.
Webinar: Post Market Activities under MDR
Due to the medical nature of the devices, incidents are bound to happen sooner or later. It is therefore crucial for any manufacturer to know how to react!
Did you know? It is a legal obligation to report incidents to the Competent Authorities and to maintain a Medical Devices Post Market Surveillance System!
State of the art of COVID-19 rapid antibody tests
The IVDD requires from manufacturers to design and manufacture devices in such a way that they are suitable for the intended purpose, taking into account the generally acknowledged state of the art. The newly published MDCG Guidance aims at helping manufacturers to fulfill this requirement. Read more about it here.
European preparedness and response to the COVID-19: a common list of rapid antigen tests
On January 2021, the Member States unanimously decided to settle a common framework covering the utilization of rapid antigen tests and the mutual recognition of COVID-19 test results within the European Community. Read more about it, here
Logistical barriers due to Brexit and MDR
Many changes are occurring on the European continent concerning transport, import and distribution. The main reasons are the consequences of Brexit and the new Medical Device Regulation, that will become fully applicable on the 26th of May 2021.