PPWR Article 45, in force since 12 August 2026
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Industry vertical · Pharma & Medical Devices
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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 Ecosystem) 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)
Ecosystem (Batribox is also approved)
Embedded batteries in medical devices, hearing aids, glucose monitors, portable diagnostic equipment.
Professional packaging (EPRO)
Citeo Pro, Léko Pro, Twiice
Packaging of products used only by professionals, such as hospital and laboratory supplies. A package also sold to households stays household packaging, even when a business buys it. Contributions and identifiers start on 1 January 2027.

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?

It depends on who uses the product, not on who buys it. Packaging of products used only by professionals is professional packaging (Citeo Pro, Léko Pro or Twiice). A package also sold to households stays household packaging, even when a business buys it, so products a pharmacy resells to patients stay household packaging. Professional packaging contributions and identifiers start on 1 January 2027.

Related

Sources & references