Avanti Europe AG

26/11/2024

We untangled the economic operators, their tasks and the flow of information..... to bring clarity to article 25 of the MDR 2017/745 👇

From the manufacturer to the user, the flow of information is thinned to the labeling. The label and the IFU, with potentially additional information depending on the nature of the medical device, are the only things the user receives as information.

Over the chain of custody of a medical device, the information from the manufacturer over each economic operator is provided "downstream". See here the parts missed per each economic operator up to the user.

27/10/2024

Transparency in the supply chain aka chain of custody ...
the easy way to tackle it 👇

MDR 2017/745 is in article 25 very clear on the requirements for transparent chains of custody and this belongs to all economic operators collaborating in rendering the chain of custody transparent. How to do it?

1️⃣: in the supply chain of a medical device, know from which economic operator you get the device and to whom (economic operator, health institution, or HCP) you are providing it.

2️⃣: understand whether you are required to name your chain of custody from point 1 to an EC REP, CH REP, or the manufacturer

3️⃣: frequently provide the data to the economic operators concerned in point 2

4️⃣: celebrate your transparency 😂 🥳 🥳

In case of need support on how to set it up or untangling a complex chain of custody, please approach us from avanti europe.

01/10/2024

Kombinationsprodukte-Konferenz 📢

Diskutieren Sie mit Fach-Experten die Konzepte rund um MDR 2017/745, Artikel 117.
Jetzt die Gelegenheit nutzen und zur Konferenz anmelden:

Was: Kombinationsprodukte in der EU (MDR, Artikel 117)
Wo: online, aus dem HomeOffice
Wann: 12.11.2024
Sprache: Deutsch
Veranstalter: alphatopics

Anmeldung direkt via link: https://bit.ly/3MQIWdS
Wir freuen uns Sie an der Konferenz zu treffen und uns mit Ihnen auszutauschen.

23/09/2024

The IFU (Instructions for Use) can get overwhelming for IVDs...
Not sure what to place in the IFU or on the label? 👇

The IVDR 2017/746 is pretty clear in Annex I, 20.4 what it is expected to be found in an IFU. This list of requirements can get overwhelming when it comes to the specific details and content for the IFU.

For the stressed IFU author, we have compiled an IFU checklist. Access it here: https://bit.ly/494TKP3

We further offer IFU reviews, IFU ghost-writing, and consulting services, don't hesitate to contacting us.

The MDR 2017/745 demands for medical devices to provide Instructions for Use (IFU) along with the product. Find here the checklist for the content

21/09/2024

Not sure about the qualification of your PRRC?. look no further ... 👇

we have prepared a PRRC eligibility checklist to easily document the required qualification of your candidate PRRC. Access it here: https://bit.ly/42hHN5F

In case you are a micro- or small entity, you are eligible to "rent" a PRRC instead of having it on your headcount list. Talk to us as we offer PRRC services in Switzerland and Europe.

The MDR 2017/745 demands in article 15 a PRRC for manufacturers and authorized representatives. The checklist serves to evluate the qualification of a PRRC.

17/09/2024

Kombinationsprodukte-Konferenz 📢

Diskutieren Sie mit Fach-Experten die Konzepte rund um MDR 2017/745, Artikel 117.
Jetzt die Gelegenheit nutzen und zur Konferenz anmelden:

Was: Kombinationsprodukte in der EU (MDR, Artikel 117)
Wo: Bonn
Wann: 12.11.2024
Sprache: Deutsch
Veranstalter: alphatopics

Anmeldung direkt via link: https://bit.ly/4f7lRQR
Wir freuen uns Sie an der Konferenz zu treffen und uns mit Ihnen auszutauschen.

08/09/2024

The IFU (Instructions for Use) can get overwhelming...
Not sure what to place in the IFU or on the label? 👇

The MDR 2017/745 is pretty clear in Annex I, 23.4 what it is expected to be found in an IFU. This list of requirements can get overwhelming when it comes to the specific details and content for the IFU.

For the stressed IFU author, we have compiled an IFU checklist. Access it here: https://bit.ly/3Hz9qxB

We further offer IFU reviews, IFU ghost-writing, and consulting services, don't hesitate to contacting us.

The MDR 2017/745 demands for medical devices to provide Instructions for Use (IFU) along with the product. Find here the checklist for the content

06/08/2024

CHRN actors module start by Swissmedic's swissdamed 🚀

Read here the impact on this new digital tool 👇

Swissmedic starts today its first module for actors registrations. Registrations in paper (or PDF) are not longer accepted. From today, CHRN registrations for actors are only accepted via swissdamed. During August, Swissmedic will import existing CHRN into swissdamed, without further actions needed from the actors, except data sanity check once transfered into the swissdamed application.

Other modules, such as the device registration module, will follow in 2025, as currently planed.
see press release here: https://bit.ly/3S4Cp27