Regulatory
CE marking & CPNP — what they mean
Aesthetic products sold in the EU fall under two main regulatory regimes depending on their classification. Here’s a plain-language guide so you can quickly identify what you’re holding and what it’s authorised for in clinical practice.
CE Mark — Medical Devices
A CE mark (Conformité Européenne) on an injectable indicates the product is classified as a medical device under the EU Medical Device Regulation (MDR, 2017/745) and has been assessed by a Notified Body for safety, performance and quality. The four-digit number after the CE mark identifies the Notified Body.
Typical CE-marked products in our range:
- Hyaluronic acid dermal fillers (Lumifil, Volifil, Profhilo, Ejal 40)
- Skin boosters and polynucleotide injectables (LumiEyes, Plinest)
- Microneedling serums used trans-dermally with sterile single-use devices
Scope of practice: CE-marked injectables are reserved for use by appropriately trained, registered healthcare practitioners. Importation, storage and use are subject to HPRA oversight in Ireland.
CPNP — Cosmetic Products
The Cosmetic Product Notification Portal (CPNP) is the EU-wide notification system established under the EU Cosmetic Products Regulation (1223/2009). Cosmetic-classified products must be registered on CPNP by their Responsible Person before being placed on the EU market — covering ingredient safety assessment (CPSR), labelling and Good Manufacturing Practice (GMP, ISO 22716).
Typical CPNP-notified products in our range:
- Mesotherapy serums applied topically with microneedling devices (Lumi-Meso range)
- Lipolytic / fat-dissolving solutions (Lemon Bottle)
Scope of practice: CPNP products are intended for topical or transdermal use in line with the manufacturer’s indications and the practitioner’s training. They are not classified as medicinal products and the practitioner remains responsible for clinical appropriateness and consent.
Authenticity & product dossiers
We supply products direct from authorised manufacturers and authorised EU distributors only. Full product dossiers — Declaration of Conformity, CE certificates, CPNP notification numbers, Safety Data Sheets and batch certificates of analysis — are available on requestfrom the manufacturer for any product in our range.
Email info@aesthetic26.ie with the product name and batch/lot number you need documentation for and we’ll request the dossier from the manufacturer for you.
This page is provided for general guidance only and does not constitute legal or regulatory advice. Practitioners are responsible for verifying that any product they use falls within their training, registration and scope of practice in the jurisdiction where they operate. For Ireland-specific questions, contact the HPRA: hpra.ie.
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