European Union Archives - Page 3 of 24

EU Commission Updates Harmonized Standards for Certain Electrical Equipment

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 Updates Harmonized Standards for Quality Management in Medical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards for quality management systems and risk management practices applicable to medical devices under the EU’s In Vitro Device R... Read More...

EU Commission Amends REACH Annexes

The Commission of the European Union (EU) has amended portions of its regulation on the registration, evaluation, authorization, and restriction of chemicals (Regulation (EC) No 1907/2006, also known as REACH) ... Read More...

EU Commission Initiates Public Consultation on RoHS

The Commission of the European Union (EU) has launched a public consultation on the EU’s Directive on the use of certain hazardous substances in electrical and electronic equipment to solicit input on potential... Read More...

EU’s MDCG Updates MDR Guidance

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU) has published an updated version of its guidance on the EU’s Medical Device Regulation ((EU) 2017/745, also known as the... Read More...

Industry Groups Call for 2-Year Extension of MDR Transition Period

Two leading medical industry groups in the European Union (EU) are calling on the European Commission to extend the transition period for the EU’s Medical Device Regulation (2017/745) to avoid what they call a ... Read More...

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746 (also known as the IVDR), in an effort to ensure ... Read More...

EU Commission Modifies REACH Regulation on CMR Substances

The Commission of the European Union (EU) has amended portions of its regulation on the registration, evaluation, authorization, and restriction of chemicals (Regulation (EC) No 1907/2006, also known as REACH) ... Read More...

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...