Our Latest News & Blogs

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.

Get ready for MDR Kapstone Medical

How do we get ready for MDR?

High level areas to consider

 

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

 

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union.

 

The clock is already ticking and the three-year transition period is counting down to 26 May 2020, which is the “Date of Application” (DoA) of the Regulation.

Kapstone Medical MDR series

What is European MDR and Why It happened, Timelines for Compliance

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

 

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.

 

The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.

Get the latest news and blogs about the Medical Device Industry.

Click 'Subscribe' to keep up with the latest trends.
Image

Kapstone Medical is a single-source service provider to medical device companies lacking the appropriate human capital to bring to market new and safe products. We provide customized solutions that are flexible and cost effective in an ever changing regulatory environment.

 

BBB accredited

Get to Market

Contact Info

Our Tweets