The European Commission, through its Implementing Decision (EU) 2021/915, adopted on June 4, 2021, a set of Standard Contractual Clauses to be used between controllers and processors. This in order to fulfill the GDPR requirements.
News
Transplants & medical devices: the Spanish Authority presents RENACER
According to the Spanish Association of Cardiology, there has been an increasing number of urgent transplants and medical devices to support said transplants in the last years. Want to know more? Visit our page!
Congress on Regulations and Compliance for Cosmetics (CRCC)
For the 6th year consecutively the European cosmetics Responsible Person Association (ERPA) is organizing the annual Congress on Regulations and Compliance for Cosmetics. Want to know more? Visit our page!
New cybersecurity obligations under Radio Equipment Directive (RED)
On October 29, 2021, the European Commission adopted a delegated act to the Radio Equipment Directive aiming at scaling up the cybersecurity of wireless devices and products for the benefit of consumers. Want to know more? Visit our page!
A reinforced role for the European Medicines Agency (EMA)
The EU regulators agreed to introduce a new set of tools to improve the EU health security coordination before and during crises by reinforcing the management of disruptions due to the scarcity of medicinal products. Want to know more? Visit our page!
Cobalt in medical devices: French CA publishes a Q&A document
The French competent authority (ANSM) has published information for medical devices containing COBALT. The ANSM informs manufacturers that as of October 1, 2021, cobalt will need to be clasified differently. Want to know more? Visit our page!
MEDICA 2021: Obelis Team Was There!
We met with over 400 manufacturers from more than 50 countries in MEDICA’s halls. Here are the latest news and insights we got from medical manufacturers.
Requirements for Legacy Devices under the MDR as of May 26, 2021
In this article we give you an overview about the MDR requirements that a legacy device must met to be considered compliant.
European Commission launches the High Level Construction Forum
On September 28, 2021, the European Commission launched the first meeting of High- Level construction forum! The main goal is to establish a new construction ecosystem; digitalized and under the green policy.
European Parliament calls for action plan to phase out animal testing
On September 16, the European Parliament adopted a Resolution calling for an EU-wide action plan to phase out the use of animals in research and testing. Want to know more? Visit our page!