January 25, 2022

[FEATURED] Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions

The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.

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January 18, 2022

[FEATURED] EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation

TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken to ease the path to implementation. It says the many new medtech regulatory shifts, guidance documents and structures adopted in 2021 must be augmented.

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January 11, 2022

[FEATURED] Where And How eIFU Rules Will Apply Under The EU’s Medical Device Regulation

Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.


European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.

The possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used under specific conditions, the document states.

“For reasons of safety and efficiency,” it notes, “users should always have the possibility to obtain those instructions for use in paper form upon request.” The document also lays out rules for eIFU information made available on manufacturers’ websites.

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January 4, 2022

[FEATURED] Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States

There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now been added to this drive.


European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.

So far, there are just six notified bodies designated under the IVDR.

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December 21, 2021

[FEATURED] EU’s First IVDR Expert Panel View Published

The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.


The IVD Expert Panel, set up in the context of the EU’s IVD Regulation, has issued its first opinion based on a manufacturer performance evaluation report submitted by a notified body.

The seven-page document has been published on the website of expert panels on medical devices and in vitro diagnostics (Expamed) and is a review of a hepatitis E virus (HEV) test.

The advice is provided in the context of the performance evaluation consultation procedure (PECP), which is an additional element of conformity assessment by notified bodies for specific high-risk in vitro diagnostic devices (IVDR Article 48.6).

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[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER

Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.