In the absence of harmonized standards NBs need to assess the compliance of mobile devices via conformity assessment procedures. Read the EC's Guidelines here!
Technology and innovation
The New Machinery Regulation Proposal: Enhanced Safety through a Simpler Framework
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.
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.
Children’s safety ensured: an evaluation of the Toys Safety Directive by the European Commission
Find out more about the evaluation by the European Commission on the Toys Safety Directive.
WHAT’S NEW WITH ELECTRONIC CIGARETTES? FINAL OPINION FROM SCHEER
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) of the EU Commission adopted o the Final Opinion on electronic cigarettes.
European Commission’s guidance on the free movement of goods
What do the guidance documents on the free movement of goods from the European Commission state?
Find here more information on the three documents.
The European privacy family & UK: towards an adequate level of personal data protection
The first step for the adoption of the adequacy decisions for transfers of personal data from the EU to the United Kingdom has been taken: the European Commission has published two draft decisions, one under the General Data Protection Regulation (GDPR) and the second one under the Law Enforcement Directive (LED).
New EU Cybersecurity Strategy and new rules to make physical and digital critical entities more resilient
On December 16, 2020, the European Commission published the EU’s Cybersecurity Strategy for the Digital Decade.
Read more about the topic in this article.
How MDR regulates software?
Artificial Intelligence (AI) has been used more and more in healthcare. Read our article to learn more about the challenges that manufacturers have to deal
The SCHREMS II CASE
Data transfer from the EEA to third countries -The finding of an adequate level of protection. The protection of personal data and its interaction with the MDR and IVDR