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Basic wound care

Plasters, sterile dressings and certain antiseptic solutions are regulated in the EU as medical devices under the MDR. They bear the CE mark, are classified by risk, and are distinct from antiseptic medicines and from cosmetics.

Plasters and adhesive dressings

Adhesive plasters, woven and non-woven dressings, and similar simple wound-covering products are medical devices under Regulation (EU) 2017/745. Their classification by Annex VIII rules is typically Class I (often as sterile, in which case the sterility aspect requires notified-body involvement). They bear the CE mark and must come with instructions for use in the appropriate languages.

Sterile and non-sterile dressings

A dressing presented sterile carries additional requirements: the manufacturer must follow the conformity-assessment procedure that addresses the sterility aspect, and the packaging must protect the sterile barrier through the labelled shelf life. The "STERILE" symbol on the package, the sterilisation method indication (for example, "STERILE EO" for ethylene-oxide sterilised), and the expiry date are mandatory pieces of information under the labelling rules of the MDR and harmonised standards.

Wound dressings with advanced functions

Beyond the simple plaster, parapharmacies sell a range of advanced wound dressings — hydrocolloid, hydrogel, foam, alginate — which are also medical devices, often Class IIa or IIb depending on intended purpose and duration of contact. Some include antibacterial agents (for example, ionic silver) and may be classified higher under the MDR depending on whether they incorporate a substance that, were it used separately, would be considered a medicinal product (the "drug-device combination" cases).

Antiseptic devices vs. antiseptic medicines

The line between an antiseptic medical device and an antiseptic medicinal product is one of intended purpose and mode of action. An antiseptic intended for the disinfection of intact skin or of the skin in connection with a medical procedure, and acting principally through physical or chemical means without a pharmacological/immunological/metabolic mode of action, may be a medical device. An antiseptic presented for the prevention or treatment of skin disease, or whose principal mode of action is pharmacological, is a medicinal product and requires a marketing authorisation. The classification follows from the presentation and from the substance, not from the consumer's intuition.

Common over-the-counter antiseptic solutions (povidone-iodine, chlorhexidine in topical solutions, hydrogen peroxide) are typically regulated as medicinal products in the EU when presented for use on broken skin and reserved to the pharmacy channel under national law. The presence of an antiseptic on a parapharmacy shelf, particularly in France, is therefore product-specific and reflects whether the specific product has been classified as a cosmetic, a medical device, or a medicinal product (which would exclude it from a French parapharmacy).

Compresses, gauze, swabs and accessories

Sterile and non-sterile compresses, gauze and swabs are medical devices in their intended use as wound-care accessories. CE marking under the MDR applies. They may be sold in parapharmacies subject to the national rules.

What labels do and do not tell you

The label of a wound-care medical device will carry the CE mark (with notified-body number where applicable), the manufacturer's name and address, the UDI, the device identifier, the instructions for use (often by symbol referring the user to printed or electronic IFU), the storage conditions, and the batch/expiry information. The label does not, by itself, certify clinical effectiveness in a specific patient situation: that is a question for the user, taking into account the device's intended purpose and any clinical advice received. For the management of any wound that does not fit the routine first-aid scope — deep, contaminated, slow-healing, or in a person with diabetes, immunosuppression or vascular disease — the appropriate advice is from a pharmacist or a physician.

Last reviewed: May 2026.