If You Outsource Manufacturing of Your Medical Device or IVD, Who is Considered the Legal Manufacturer?

With the publication of Europe’s Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture or relabel devices (OBL/PBL) are wondering if they will be considered the “legal manufacturer” of the device they sell. Much of the confusion around this issue stems from the assumption that there can be only one legal manufacturer. But the MDR and IVDR make it crystal clear: one device can potentially have multiple legal manufacturers and each one […]

The European IVDR Requirements – What You Should Be Doing Now to Prepare

The IVDR deadline will be here before you know it. Here are some important reasons to take the IVDR seriously and start planning early…like now. Here are some important things to consider. 1 – Conduct an Internal IVDR Gap Assessment ASAP It’s definitely not too soon to conduct a robust assessment to see where you stand with regard to future compliance in Europe. A gap assessment is the first step and should answer these questions, among others: What classification will […]

IVDR Conformity Assessment, Postmarket Surveillance, and Vigilance Requirements

The EU’s new In Vitro Diagnostic Regulation (2017/746) (IVDR) places a significant new regulatory burden on IVD manufacturers. Not only will 80-90% of all manufacturers be subject to ongoing Notified Body scrutiny, they will also be required to produce reams of premarket technical data in order to gain CE Marking under the IVDR. While a significant number of IVD manufacturers have a quality management system in place, many do not. This is a four-part series on the EU IVDR. […]

IVDR Technical Documentation Needed to Support CE Marking Certification in Europe

The implementation of the In Vitro Diagnostic Regulation (IVDR – EU 2017/746) may seem like a long way off…but the deadline will be here before you know it. An estimated 80-90% of all IVDs sold in Europe will be subject to Notified Body approval under the IVDR, up from a scant 10-20% under the IVDD. There are many reasons to get started early, and foremost among them is the need to assemble the performance data and supporting clinical evidence required […]

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