European MDR Certification
Every Filladerm product is certified under EU MDR
Class III certified ISO 13485 manufacturing EUDAMED registered
Regulation (EU) 2017/745, known as the MDR, is the European Union’s framework for regulating medical devices — and since its expansion under Annex XVI, it also covers aesthetic products like dermal fillers. Under MDR, injectable dermal fillers are classified as Class III, the highest risk category, alongside implants. That means every product must pass a full clinical evaluation, an independent Notified Body design review, and ongoing post-market safety monitoring before it can carry the CE mark.
For you, this translates into one thing: every Filladerm product you inject has been through the toughest safety and quality bar in the industry — not just tested once, but continuously monitored.
Every Filladerm product is certified under EU MDR
Class III certified ISO 13485 manufacturing EUDAMED registered
Regulation (EU) 2017/745, known as the MDR, is the European Union’s framework for regulating medical devices — and since its expansion under Annex XVI, it also covers aesthetic products like dermal fillers. Under MDR, injectable dermal fillers are classified as Class III, the highest risk category, alongside implants. That means every product must pass a full clinical evaluation, an independent Notified Body design review, and ongoing post-market safety monitoring before it can carry the CE mark.
For you, this translates into one thing: every Filladerm product you inject has been through the toughest safety and quality bar in the industry — not just tested once, but continuously monitored.
What Filladerm's MDR certification covers
- CE Marking — Full compliance with Regulation (EU) 2017/745, verified by Notified Body [name / number]
- Class III Classification — Highest scrutiny level under MDR Annex XVI, Group 3
- ISO 13485 Manufacturing — Audited quality management system at every production stage
- Clinical Evidence — Backed by clinical data and Post-Market Clinical Follow-up (PMCF)
- EUDAMED Registration — Full traceability via Unique Device Identifier (UDI) on every batch
- Periodic Safety Update Reports (PSUR) — Ongoing, documented safety monitoring
What Filladerm's MDR certification covers
- CE Marking — Full compliance with Regulation (EU) 2017/745, verified by Notified Body [name / number]
- Class III Classification — Highest scrutiny level under MDR Annex XVI, Group 3
- ISO 13485 Manufacturing — Audited quality management system at every production stage
- Clinical Evidence — Backed by clinical data and Post-Market Clinical Follow-up (PMCF)
- EUDAMED Registration — Full traceability via Unique Device Identifier (UDI) on every batch
- Periodic Safety Update Reports (PSUR) — Ongoing, documented safety monitoring
