European Union Archives - In Compliance Magazine

EU Commission Updates Biological Safety Standards Applicable under MDR

The Commission of the European Union (EU) has updated the list of standards that can use to demonstrate the biological safety of medical devices under the EU’s Medical Device Regulation ((EU) 2017/745, or the M... Read More...

EU Commission Updates Harmonized Standards for Various Electrical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards that can be used to demonstrate conformity with the safety requirements of the EU’s Radio Equipment Directive (2014/35/EU, ... Read More...

EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical device instructions in electronic form under the scope of the EU’s Medical Device Regulation (EU 2017/745, or the ... Read More...

EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical device database intended to serve as a repository for detailed information on medical devices approved under the EU’s Medica... Read More...

EU Commission Seeks to Expand RED Cybersecurity Requirements for IoT Devices

The Commission of the European Union (EU) is taking steps to specifically include the cybersecurity of internet-connected equipment under the scope of its Radio Equipment Directive (2014/53/EU, also known as RE... Read More...

EU Commission Updates List of Harmonized Standards for Toys

The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its directive relating to the safety of toys (2... Read More...

EU Task Force Offers Clarification of Surveillance Requirements for Legacy Medical Devices

A European Union (EU) task force has issued a document intended to clarify the application of the EU’s Medical Device Regulation (2017/745, also known as the MDR) post-market surveillance requirements to legacy... Read More...

EU Market Surveillance Regulation Takes Effect

A landmark piece of European Union (EU) legislation intended to strengthen market surveillance of products for compliance with applicable regulations is now in full effect. Issued by the EU Commission in Jul... Read More...

EU Commission Moves to Require USB-C Charging

In a move that will have significant consequences for developers of a wide range of portable electronic devices, the Commission of the European Union (EU) has proposed the adoption of uniform charging capabilit... Read More...

EU Commission Updates List of Harmonized Standards for MDR

The Commission of the European Union (EU) has updated its list of harmonized standards applicable to medical devices to reflect the latest available technical and scientific information. According to Commiss... Read More...