health claims

Article

IVDR, IVDs and mass extinction

More interesting things from the RAPS Convergence conference. If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD…

Article

Supply chain and economic operator regulation under the MDR and IVDR

One of the interesting features of the new MDR and IVDR is the new chapter on economic operators (chapter II), which implements a completely new (to the medical devices industry at least)…

Article

San Jose CA workshop: Everything You Always Wanted to Know about the EU Medical Devices Regulation, but Were Afraid to Ask

If you have questions about what the MDR will mean for your company and happen to be in San Jose in California on 25 September, consider attending the evening workshop that Factory…

Article

MDR and IVDR transitioning – where are you in your process?

I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where…

Article

An unsurprising case of software qualification

First: my apologies for the collapsed frequency of articles on this blog – I’m very very busy, literally day and night, with questions about any and all aspects of the MDR and…

Article

Can unhealthy foods enter the ‘health halo’? The boundaries of health claims in the absence of nutrient profiles

To date, about 30% of pre-packed food products marketed in the EU have entered the ‘health halo’, attracting consumers by scientifically proven health benefits. The Claims Regulation provides that food products must…

Article

Netherlands to adopt medical devices anti-corruption legislation

As we say in Dutch: the day that you knew that would come is finally here. The legislative proposal to grant the Healthcare Inspectorate (IGZ) IGZ enforcement powers in the field of…

Article

Presentations MDR Implementation Seminar

With the definite text published less than a week ago, we welcomed over 150 industry representatives interested in the new Medical Devices Regulation. Erik Vollebregt kicked off the seminar with his presentation…

Article

Final MDR and IVDR texts published

As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”. Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU)…

Navigate through our knowledgebase