Notification of the MIR to CAs or EUDAMED

Order now your Vigilance Card

on the next Order Form with Obelis.

Order now your Vigilance Card

on the next Order Form with Obelis.

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Pre-assessment of the case

Everything you need to deal with medical devices and IVD's incidents. Our Medical Devices & IVD Vigilance Cards services include:

OBELIS VIGILANCE CARD

Did you know?

It is a legal obligation to inform the Competent Authorities about reportable cases and maintain a Medical Devices Post-Market Surveillance System!

Did you know?

It is a legal obligation to inform the Competent Authorities about reportable cases and maintain a Medical Devices Post-Market Surveillance System!

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Select if you require a Medical Devices or a Cosmetics Vigilance card

We receive your request and promptly generate your vigilance card

You are all set and we can start your post Market Surveillance System!

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You might also be interested in:

What is RAPEX and how does it affect your business in Europe?

Medical Devices Vigilance – What to do when an incident occurs?

Supporting during post market surveillance

Support during manufacturer investigation and reporting decision

Communication with the CAs concerning vigilance

Support in drafting of the Manufacturer Incident Report notification form (MIR)

Support in drafting of the Field Safety Corrective Actions (FSCA) notification form

Notification of the FSCA Report to CAs or EUDAMED

Follow-up with the CA on the FSCA

Communication with the importer during the post market surveillance

Support in drafting of the Field Safety Notice (FSN)