French EPR for Pharma & Medical Devices brands.

Pharma and medical device manufacturers shipping to France face three EPR streams typically (packaging via Adelphe, WEEE via Ecosystem, batteries via Corepile) plus separate regulatory frameworks (EU MDR 2017/745 for medical devices, EMA / ANSM for pharma authorisation). EPR covers the packaging and device end-of-life; product regulation covers safety and authorisation. This page focuses on EPR.

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EPR streams typically in scope for Pharma & Medical Devices

Household packaging

Adelphe (often) or Citeo

Pharma packaging — blister packs, bottles, cartons. Adelphe historically registers pharma producers.

WEEE Pro / professional electronics

Ecosystem or Ecologic (Pro sub-stream)

Electronic medical devices: monitoring equipment, lab equipment, imaging accessories, networked devices, anything with a power cord or battery.

Batteries (professional)

Corepile or Screlec

Embedded batteries in medical devices, hearing aids, glucose monitors, portable diagnostic equipment.

Professional packaging (EPRO)

Citeo Pro

B2B shipments to French hospitals, clinics, pharmacies, laboratories.

Adjacent regulatory layers (not EPR — for context)

Beyond EPR, Pharma & Medical Devices brands face additional French and EU regulatory requirements. We list them here so you can see the full compliance map — but these are NOT covered by our EPR mandataire scope. We coordinate with specialists for these layers.

EU MDR (Medical Device Regulation 2017/745)

Medical devices placed on the EU market must comply with MDR. Includes CE marking, UDI registration, EUDAMED database registration. Separate from EPR. Handled by a Notified Body and an EU Authorised Representative (different role from EPR mandataire).

ANSM authorisation for pharma

Pharmaceuticals require ANSM (Agence nationale de sécurité du médicament) or EMA authorisation before French sale. Independent of EPR.

EU AR for medical devices vs EPR mandataire

These are different legal roles. The EU Authorised Representative under MDR Article 11 is an EU-established entity responsible for product safety and incident reporting. The EPR mandataire is a France-established entity responsible for packaging end-of-life. Same company sometimes provides both, but the regulatory frameworks are distinct.

Hazardous waste handling

Certain medical waste (sharps, contaminated devices) falls outside standard EPR streams and requires hazardous-waste compliance under separate rules. Not covered by the EPR mandataire role.

Frequently asked questions

Does Adelphe handle medical device packaging?

Yes for pharma-related packaging. For pure medical devices (non-pharma), Citeo or Léko may be more common. The choice depends on product category. We confirm at scope-check.

Our active implantable medical device has its own MDR class. Does EPR still apply?

EPR applies to the packaging and any electronic / battery components. The device itself, when implanted, is not in scope of EPR (no end-of-life consumer disposal). External devices (monitors, controllers) are in WEEE scope.

Hospital procurement asks for our SYDEREP IDU. Why?

Large French hospital groups run supplier compliance scoring. They verify your SYDEREP record before purchase orders to hedge residual liability and demonstrate procurement compliance. A non-registered non-EU supplier increasingly cannot win hospital tenders.

We sell B2B to French pharmacies. Same as B2C?

B2B sales to French pharmacies are EPRO (professional packaging via Citeo Pro), not household. Pharmacies that then resell to consumers handle the household packaging on their side. Confirm chain of title and B2B vs B2C split with your commercial contract.

French EPR for Pharma & Medical Devices brands.

EPR streams typically in scope for Pharma & Medical Devices

Adjacent regulatory layers (not EPR — for context)

Frequently asked questions

Related

Sources & references