European MDR,
CE marking and what they mean for your clinic
Aesthetic injectables are regulated as medical devices in the EU
Filladerm is a wholesale distributor under MDR Article 14.
CE marking and the Declaration of Conformity are held by the legal manufacturer named on each product.
Regulation (EU) 2017/745 — the Medical Device Regulation, or MDR — is the European Union’s framework for medical devices. Since its expansion under Annex XVI, it also covers products with no intended medical purpose, including dermal fillers.
Under MDCG 2023-5, resorbable dermal fillers are classified as Class III, the highest risk category. Permanent fillers are Class IIb. Class III means the manufacturer must hold a notified body certificate covering design examination, maintain clinical evidence demonstrating the product’s safety, and run continuous post-market surveillance before the device may carry a CE mark.
Annex XVI products are also subject to the Common Specifications in Implementing Regulation (EU) 2022/2346, which require that these products be administered only by appropriately trained healthcare professionals and not used on persons under 18.
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 CE marking under MDR covers
When a device carries a CE mark under European MDR, the manufacturer has completed the following:
- CE marking — conformity with Regulation (EU) 2017/745, assessed by a notified body whose four-digit number appears alongside the mark
- Risk classification — Class III for resorbable fillers under Annex XVI, Group 3
- ISO 13485 — an audited quality management system at the manufacturing site
- Clinical evidence — clinical evaluation and Post-Market Clinical Follow-up (PMCF)
- UDI — a Unique Device Identifier enabling batch-level traceability
- PSUR — periodic safety update reporting to the notified body
What we do:
- We supply only genuine product from the official distributors
- The Declaration of Conformity and notified body certificate for each product are available on request
- Batch numbers are recorded against every dispatch
- Products are stored and shipped within the range specified in the manufacturer’s IFU
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
We believe in transparency, with your clients and with regulators. Every product is manufactured and tested to the highest industry standards
All products are certified
FAQ
Are all Filladerm products Class III certified?
Yes. All injectable dermal fillers are certified as Class III medical devices under MDR Annex XVI, having passed clinical evaluation and Notified Body review. Some other products in the catalogue may fall under a different MDR class, but all carry a valid CE mark.
What's the difference between MDR and the older MDD?
MDR (2017/745) replaced the MDD in 2021 with stricter rules: it added Annex XVI, covering products like dermal fillers that MDD didn’t regulate, and requires stronger clinical evidence, UDI/EUDAMED traceability, and continuous post-market monitoring (PSUR, PMCF).
Can I get certificates for a specific batch?
Yes. Every batch has a Unique Device Identifier (UDI) registered in EUDAMED. Contact customer service with your batch/lot number to receive the Certificate of Analysis or Declaration of Conformity.
