European Union Archives - In Compliance Magazine

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...

EU Commission Updates Harmonized Standards for In Vitro Devices

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

EU Proposes Rules on the Use of AI

The Commission of the European Union (EU) has released a comprehensive proposal for a regulation governing the use of artificial intelligence (AI). Released in late April, the EU Commission’s proposal to provi... Read More...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the EU are now fully applicable to all devices. As of May 26, 2021, all new and existing medical devices must now conform ... Read More...

EU Commission Updates Harmonized EMC Standards for Certain Equipment

The Commission of the European Union (EU) has taken steps to update the versions of certain harmonized standards used to evaluate the electromagnetic compatibility of certain devices and equipment. In an Imp... Read More...

EU Commission Opens Options for Remote Audits for Medical Devices

The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the European Union (EU) is taking steps to permit the limited use of remote audits for some medical devices during the current g... Read More...

EU Pushes for “Right to Repair” for Products

As part of the widespread effort to boost environmental sustainability efforts in the European Union (EU), the EU Parliament has passed a resolution calling on the EU Commission to grant consumers a “right to r... Read More...

EU Commission Issues Regulation Regarding Single-Use Medical Devices

The Commission of the European Union (EU) has issued common specifications for the reprocessing of single-use medical devices. Published in mid-August in the Official Journal of the European Union, Commission ... Read More...

EU Commission Amends Annex XVII of REACH

The Commission of the European Union (EU) has implemented new restrictions regarding the use of the chemical diisocyanates under its regulation addressing the registration, evaluation, authorization and restric... Read More...

EU Commission Releases 2019 RAPEX Summary Statistics on Unsafe Consumer Products

The Commission of the European Union (EU) has released statistics on notices of unsafe, non-food consumer products that have been processed through the EU’s rapid information system (RAPEX) for the year ending ... Read More...