Regulatory identity — European Union
This document is technical information about materials. It does not recommend any procedure or product.
Regulatory identity by market
How are ECM-active materials regulated in European Union?
Of the 15 materials in this atlas, 7 could be classified in European Union from public sources — 7 as medical devices. The remaining 8 could not be established and are marked as such rather than inferred.
How each material in this atlas is classified in European Union, with the legal basis where a classification could be established.
| Material | Classification | Note | Basis |
|---|---|---|---|
| Animal-derived collagen | unclassified | Not established from public sources as of the revision date below. | — |
| Botulinum toxin type A | unclassified | Not established from public sources as of the revision date below, though the medicinal-product pathway is the expected route given the classification in the two markets confirmed here. | — |
| CaHA (Calcium hydroxylapatite) | medical-device | Annex XVI, Section 3 of the MDR covers substances intended for facial or other dermal filling by injection, bringing such products under the Regulation even without an intended medical purpose. | Legal text |
| Crosslinked HA (Crosslinked hyaluronic acid) | medical-device | Annex XVI, Section 3 of the MDR covers substances intended for facial or other dermal filling by injection, bringing such products under the Regulation even without an intended medical purpose. | Legal text |
| Exosomes (Extracellular vesicles) | unclassified | Not established from public sources as of the revision date below. | — |
| hADM (Human acellular dermal matrix) | unclassified | Not established from public sources as of the revision date below. | — |
| Non-crosslinked HA (Non-crosslinked hyaluronic acid) | unclassified | Not established from public sources as of the revision date below. Annex XVI of the MDR is framed around filling by injection, and whether a non-shaping solution falls under that framing could not be confirmed here. | — |
| PCL (Polycaprolactone) | medical-device | Annex XVI, Section 3 of the MDR covers substances intended for facial or other dermal filling by injection, bringing such products under the Regulation even without an intended medical purpose. | Legal text |
| PDLLA (Poly-D,L-lactic acid) | medical-device | Annex XVI, Section 3 of the MDR covers substances intended for facial or other dermal filling by injection, bringing such products under the Regulation even without an intended medical purpose. | Legal text |
| PDO (Polydioxanone) | medical-device | Falls under the MDR. Note the difference from the injectable materials in this reference: Annex XVI covers substances introduced by injection for filling, whereas thread products are handled under the general provisions of the Regulation. | Legal text |
| PDRN (Polydeoxyribonucleotide) | unclassified | Public sources describe both nationally authorised medicinal products and CE-marked devices containing nucleotide-derived agents, so no single classification holds across the market. Not established as of the revision date below. | — |
| PLGA (Poly(lactic-co-glycolic acid)) | medical-device | Falls under the MDR. Note the difference from the injectable biostimulators on this site: Annex XVI covers substances introduced by injection for filling, whereas thread products are handled under the general provisions of the Regulation. | Legal text |
| PLLA (Poly-L-lactic acid) | medical-device | Annex XVI, Section 3 of the MDR covers substances intended for facial or other dermal filling by injection, bringing such products under the Regulation even without an intended medical purpose. | Legal text |
| PN (Polynucleotide) | unclassified | Public sources describe both nationally authorised medicinal products and CE-marked devices containing nucleotide-derived agents, so no single classification holds across the market. Not established as of the revision date below. | — |
| rhCollagen (Recombinant human collagen) | unclassified | Not established from public sources as of the revision date below. | — |
COS cosmetic · MD medical device · RX drug · — not established in public sources