What to expect in the new EU in vitro diagnostics regulation?

Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk Viëtor about Skyline Diagnostics’ efforts to bring its products to the market and presentations of my partner Carine van den Brink about marketing, advertising and online sales of IVDs and me about software under the IVD directive and developments in patient data regulation. All presentations will be posted on my firm’s website by the end of the week.

And we had the interesting, detailed and comprehensive overview of the impending proposal of changes to the IVD directive provided by Sabine Oshe, Head of Medical Devices Certification BSI Germany, one of the premier notified bodies in the market that has been close to the legislative proposal in its official capacity.

As you know, the revision of the general medical devices directive and the active implantables directive run in parallel, so  many of the procedural changes that we can envisage not to be strictly IVD related, will also show up in the new regulation for medical devices, for example – as Ms Oshe informed us – alignment with the market surveillance ‘supply chain regulation’ 768/2008, as has already happened with another CE directive (although it was not revised as regulation), the Toy Directive. It is no surprise that this will also happen for the IVD regulation, and, as I expect, for the medical devices regulation. The result is increased obligations for the manufacturer, and new ones for the authorised representative, importer and distributors. Take a look in the Toy Directive, and expect something like that.

I will summarise her presentation in this post, and provide some of my own comments in the bargain. Out of all of the information provided, I think that this picture about the increased regulatory burden on the IVD industry says more than a thousand words: the majority of regulated IVDs will require intervention by a notified body.

General requirements

As was expected, it was confirmed that the GTHF approach to classification will replace the correct illogical and outdated list-based system, more or less like so:

The corresponding conformity assessment routes also follow the GTHF model like this:

Clinical substantiation

A lot will change in terms of substantiation of the device and the consistent implementation of this in its quality system by the manufacturer and the verification thereof by the notified body, leading to more in-depth audits and mandatory surprise visits by the notified body. Expect the assessment team standards in the notified body code to be implemented in the regulation. Notified bodies, for their part, will need to work hard to access more specific external expertise and reference laboratories for the mandatory testing of samples collected during the increased supervisory activities (such as batch verification).

Post marketing

As was to be expected following Commissioner Dalli’s Joint Action Plan regarding market surveillance, there will be a strong focus on increased measures for post market surveillance/ PMCF in some form, vigilance,  traceability to facilitate recall and  greater communication between member states including the Eudamed database.

Interim measures

As for interim measures (the regulation will likely not enter into force before 2015 and may then still have a transitional period) expect all the measures set out in Commissioner Dalli’s Joint Action Plan.

Implementing legislation

In the works are a Commission Implementing Regulation on the design and the supervision of Notified Bodies under Directive 90/385/EEC on active implantable medical devices and 93/42/EEC on medical devices. IVDs are not included at present but its philosophy is likely to apply. The reason is that the Commission feels severely let down by the member states with respect to their supervision and accreditation of notified bodies and seeks to bolster the notified bodies substance and supervision. In addition there will be a Commission Recommendation on the audits performed by notified bodies in the field of all medical devices, including IVDs.


This is a very rough summary of the presentation and I hope I did justice to the level detail of the information conveyed in it. Ms Oshe informed me that BSi plans to organise a webinar as soon as the text is officially public, which I recommend to watch for. Of course I will also blog about this as soon as I have the opportunity.

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