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Kapstone Medical MDR series

EUDAMED Database and UDI

Part 7 in a 7-part series on the EU’s Medical Device Regulation

The European Database for Medical Devices (EUDAMED) was conceived 20 years ago in 1998, originally as part of the In Vitro Diagnostics Devices Directive (IVDD) and included the Medical Devices Directive (MDD).

 

Under the new MDR that replaces the MDD, the European Commission recognized that to fully support the more stringent requirements for filing, reporting, and continuing surveillance, it would need to greatly expand the capabilities of the database for monitoring and data collection.

Kapstone Medical MDR series

Post Market Surveillance

Part 6 in a 7-part series on the EU’s Medical Device Regulation

 

The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF) that moves closer to the FDA’s approach.

 

The FDA defines PMS as the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.”

Kapstone Medical MDR series

How Clinical Evidence Requirements Affect Medical Device Approvals

Part 5 in a 7-part series on the EU’s Medical Device Regulation

 

Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR) are the new requirements around clinical evidence.

 

Under the MDR, device manufacturers marketing products in the EU will face some additional hurdles,

Kapstone Medical MDR series

Product Portfolios and Technical Documentation

Part 4 in our 7-part series on meeting the new requirements under the EU MDR

 

Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews.

 

Definitions and Reclassification

Kapstone Medical MDR series

Notified Bodies

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.

A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.

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