Saatja: Vanessa-Alexandra Vasile <
[email protected]>
Saaja: RA MSO
Teema: Inquiry about national registration and reporting requirements for medical devices and in-vitro-diagnostics
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Dear Sir or Madam,
Johner Medical GmbH is an EU Authorized Representative in accordance with Articles 11 and 12 of the Medical Device Regulation (MDR) (2017/745) and the In Vitro Diagnostic Regulation (IVDR) (2017/746), based in Germany.
As an EU Authorized Representative, we strive to provide comprehensive regulatory support to our customers. We regularly receive inquiries regarding the additional registration of medical devices in the individual EU Member States while the European database is not yet fully operational.
In order to be able to offer our customers precise and legally compliant support, we would be very grateful for your feedback on the specific national requirements for the registration and reporting of medical devices and in-vitro-diagnostics in your country.
We are particularly interested in the following points:
- Registration and reporting obligations: Are there national regulations that go beyond European requirements? If so, what additional registration and reporting obligations exist for manufacturers, importers, and distributors?
- Language requirements: In which language must documents be submitted?
- Role-specific requirements: Are there country-specific regulations for different economic operators (e.g., manufacturers, importers, distributors, authorized representatives)?
We would also like to understand which registration obligations importers must fulfil and how these can be complied with in the case of direct imports.
- Additional national requirements: Are national databases, fees, or mandatory certifications required?
We would appreciate any references to official guidelines, national laws, or regulatory documents.
Please also let us know your preferred contact points for further communication.
Thank you in advance for your support!
With best regards,
Vanessa-Alexandra Vasile
Vanessa-Alexandra Vasile B.Sc.
Beraterin
<https://www.johner-institut.de/fileadmin/bilder/email_signatur/Logo-Johner-Institut.jpg>
Johner Institut GmbH
[email protected] <mailto:
[email protected]>
Tel.: +49 (0) 7531 9450020
Reichenaustraße 39a
D-78467 Konstanz
HRB 710768 | Amtsgericht Freiburg
Umsatzsteuer-ID: DE292335387
Geschäftsführer: Markus Gerhart
<https://www.johner-institut.de/gratis-angebote/instituts-journal/>