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Every F. Bosch product ships with the full document pack. ISO 13485 governs the quality management system across every facility in our network. EU MDR and EU PPE conformity declarations cover the EU regulatory perimeter. Your customs broker gets what they need, every time.
- Why it matters
ISO 13485 is the universal pass-through standard for medical devices. Without it, EU MDR conformity is impossible. F. Bosch holds an active ISO 13485 certificate and our manufacturing partners are audited against the same QMS.
What you getAnnual ISO 13485 certificate, scoped to F. Bosch's product range, available on every shipment.
Last verified: July 2026Request this document - Why it matters
Any medical device sold in the EU must conform to EU MDR. F. Bosch acts as the legal manufacturer for Examination Gloves and Protective Clothing; for sterile devices, our partner facility holds the manufacturer status and discloses it on the Declaration of Conformity.
What you getDeclaration of Conformity per SKU shipped, naming the legal manufacturer of record, plus the relevant CE marking.
Last verified: July 2026Request this document - Why it matters
Many F. Bosch products are dual-purpose: they're medical devices under EU MDR AND personal protective equipment under EU PPE. We provide both Declarations of Conformity so your customers can use the products in either context.
What you getEU PPE Declaration of Conformity for the relevant SKU categories, plus PPE category (I / II / III) classification.
Last verified: July 2026Request this document - Why it matters
CE marking is the visible badge your customers look for at the box level. Self-certified Class I devices carry CE without a notified-body number; higher-risk devices show the four-digit NB number where required.
What you getCE mark on the carton + Declaration of Conformity (with notified-body ID only where the device class requires it).
Last verified: July 2026Request this document - Why it matters
Every glove batch is AQL-checked against EN 455. F. Bosch gloves typically run AQL 1.5 for examination grades, the level hospital tender boards expect.
What you getBatch-level QC report referencing EN 455 acceptance criteria, available on demand for any container.
Last verified: July 2026Request this document - Why it matters
Many F. Bosch glove products are dual-classified as EN 455 (medical) AND EN 374 (chemical / microbial protection). This lets distributors sell into hospital, industrial, food-contact and laboratory channels with the same product.
What you getEN 374 compliance documentation, indicating the protective categories the gloves are tested against.
Last verified: July 2026Request this document
Who issues which document.
F. Bosch holds the EU MDR legal manufacturer certification for Examination Gloves and Protective Clothing. For these families, F. Bosch is named as Manufacturer on the Declaration of Conformity, the IFU and the packaging. For sterile families (Surgical Gloves, sterile Hospital Disposables), the partner facility is the legal manufacturer and is named on the same documents. This is the standard industry approach for OEM-branded sterile devices. Your customs broker and your regulator both see the right entity for the right product.
Audited by the bodies the EU actually trusts.
F. Bosch's certifications are issued and maintained by accredited EU notified bodies: the organizations the European Commission designates to verify conformity. We don't list specific body names publicly to protect commercial confidentiality, but every Declaration of Conformity carries the body's four-digit identification number.
Apply for partnership to download every document.
We publish the complete F. Bosch document pack (certificates, declarations, batch reports, IFUs) through your distributor portal the moment partnership is approved.
Every shipment carries the full document pack, tailored to your destination.