CE marking, EN 455 and the declaration of conformity: what to ask your supplier for

During an inspection, the inspector does not look at the invoice but at the product documents. Here are the documents that must exist for the consumables in a practice or laboratory, and where to get them.

CE marking is not a decorative logo

The CE marking on the box means the manufacturer declares that the product meets the European requirements that apply to it. For medical devices, the current framework is Regulation (EU) 2017/745. If a four-digit number appears next to the logo, that is the notified body that assessed the product. A missing number is not a problem in itself: for lower risk classes, the manufacturer can declare conformity under its own responsibility.

The declaration of conformity

This is the document issued by the manufacturer for a specific product, stating which standards it meets and on what basis. It is not the same as the distributor’s ISO certificate. When you ask for documents for a consumable, this is what you ask for.

For the products in our catalogue, the declaration of conformity is attached to the product page. After you order, you will also find it in your account under My certificates, grouped by order, so you don’t have to search through old emails.

The harmonised standards you see most often

Standard	What it covers
EN 455	Single-use medical gloves: freedom from holes, mechanical strength, biological safety, shelf life
EN 374	Protective gloves against chemicals and microorganisms
EN 13795	Surgical drapes and gowns
ISO 13485	Quality management system for medical devices, at the manufacturer and the distributor

What to ask your supplier for, in practice

• The manufacturer’s declaration of conformity for each product code
• The distributor’s ISO 13485 certificate, if the purchase requires it
• The batch and expiry date, stated on the invoice or delivery note
• Instructions for use in Romanian, where the product requires them

Our medical device activity is covered by ISO 13485 certification and our management system by ISO 9001, both issued by SRAC, accredited by RENAR, and recognised through the IQNet network. The scans are public, on the Certificates and compliance page.