MDR 2017/745 — Article 87

Adverse Event Reporting

Orvida maintains a post-market surveillance system under MDR 2017/745. Licensed practitioners are required to report any serious adverse events to the competent authority.

Regulatory Framework

Reporting Obligations

MDR 2017/745 establishes clear timelines and responsibilities for all parties in the medical device supply chain.

Your obligation as a practitioner

  • Report serious adverse events within 15 days of becoming aware — or immediately for events involving risk to life.
  • Report non-serious adverse events within 30 days via the national competent authority portal.
  • Retain records of product lot numbers, injection date, and patient presentation for any reportable event.
  • Notify Orvida at vigilance@orvida.eu in parallel with your regulatory report.

Our obligation as distributor

  • Maintain post-market surveillance (PMS) records for all distributed Sofiderm products under ISO 13485 and MDR 2017/745.
  • Forward adverse event reports received from practitioners to the manufacturer, Hangzhou Techderm, within the regulatory timeline.
  • Notify INFARMED (Portugal) and/or AEMPS (Spain) as the competent authority within statutory timeframes.
  • Co-operate with the manufacturer on Periodic Safety Update Reports (PSURs) and trend reports as required under MDR Annex III.
Competent Authorities

Report an Adverse Event

Submit your report directly to the competent authority in the country where you practise. Contact Orvida in parallel at vigilance@orvida.eu.

🇵🇹

Portugal

INFARMED
Contact
Phone number to be added
Distributor Authorisation
PT authorisation number to be added
🇪🇸

Spain

AEMPS
Distributor Authorisation
ES authorisation number to be added
Pharmacovigilance Contact

Reach Our Responsible Person

All pharmacovigilance communications — adverse event notifications, PSUR requests, device complaints — should be directed to the address below. We respond within 2 working days.

Pharmacovigilance Email
vigilance@orvida.eu
Responsible Person
Diretor Técnico name and Cédula to be added

Instructions for Use (IFU)

Product IFUs are provided with each unit and are available upon request for authorised practitioners. Contact info@orvida.eu to request a specific IFU in PDF format.


IFU download links will be published here once document management is in place.

As an authorised distributor under EU Regulation 2017/745 (Medical Device Regulation), Orvida maintains post-market surveillance records, forwards adverse event reports to Hangzhou Techderm, and notifies the competent authority within statutory timeframes.
MDR 2017/745 Article 87 — Orvida position statement