mdr Archives - In Compliance Magazine

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its regulations under the EU’s Medical Device Regulation (2017/745, or MDR) and the In Vitro Diagnostic Regulation (2017/746... Read More...

EU Commission Proposes to Extend MDR/IVDR Deadlines

The Commission of the European Union (EU) has proposed extending the transition period for existing medical devices under its Medical Device Regulation (EU 2017/745, also known as the MDR) and the In Vitro Diag... 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 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 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...

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...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European Union (EU) have approved a proposal by the European Commission to delay by one year the date of application o... Read More...

EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745, also referenced as the MDR) that effectively extends the transition period for certain Class 1 medical devices. ... Read More...

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

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