Number of Notified Bodies Pursuing MDR and IVDR Certification Continues to Dwindle

EU MDR (2017/745) Update

It is commonly said that a rising tide lifts all boats. However, when the tide recedes it leaves many boats stranded, and this is exactly how some medical device and IVD companies will feel over the next several years. Just a few years ago, Notified Bodies (NBs) were bountiful, accommodating, and hungry, but times have changed. Today, you are more likely to be the one doing the selling in the hope that your NB will continue to serve you in […]

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What Will Happen to UK-Based Notified Bodies and Authorized Representatives after Brexit?

It seems quite likely that on January 31, 2020 the United Kingdom’s uneasy relationship with the European Union will officially end and UK residents will wake up as non-EU residents on February 1. Medical device companies and UK-based Notified Bodies and Authorized Representatives have been gnashing their teeth even since the momentous vote by UK citizens. Will UK-based Notified Bodies such as BSI still be allowed to certify medical devices for CE and audit the quality management systems of their […]

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Europe’s New Medical Device Directive – Transitioning from MDD to MDR

There are two things all our customers agree on: transitioning to the EU Medical Device Regulation (MDR) won’t be easy, and you need to start your transition now if you’re going to meet the deadline. We couldn’t agree more. Europe’s replacement for the Medical Device Directive has a 3-year transition period and represents a considerable compliance challenge, but companies that start their transitions early and follow a solid, well-developed transition plan will find themselves with a competitive advantage. These organizations should […]

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The New EU In Vitro Diagnostic (IVD) Regulation: What You Need to Know

In May 2016, European Union (EU) institutions agreed to draft text for the In Vitro Diagnostic Device Regulation (IVDR) that will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. The new regulation introduces significant changes for IVD manufacturers that currently hold a CE Mark or plan to market their products in Europe. To start getting ready, Oriel STAT A MATRIX has compiled a list of high-level compliance changes that will need to be considered. Updated IVDR Timing The […]

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