Compliance & Certifications
Built for regulated markets.
Backed by the right documentation.
Declarations, certificates and test reports for every regulated product, organised by product and order in your Customer Portal.
Regulatory Framework
Four frameworks behind every regulated product.
EU MDR 2017/745
Examination and surgical gloves, hospital disposables and diagnostic instruments placed on the EU market.
- EU Declaration of Conformity
- EU Authorised Representative
- UDI and EUDAMED records
EU PPE 2016/425
Protective gloves and clothing, assessed by a notified body according to risk category.
- EU Type-Examination (Module B)
- Category II: Module C
- Category III: Module C2 or D
CE Marking
Applied once the conformity assessment is complete. The declaration behind it is the proof.
- Declaration of Conformity
- Notified-body number where required
ISO 13485:2016
Our quality-management system for medical devices, independently certified.
- Certified by Bureau Veritas
- Scope and validity stated on the certificate
Product Standards & Testing
Tested to the standard. Reported by product.
Medical Gloves for Single Use
Freedom from holes, physical properties, biological evaluation and shelf life. EN 455-1 requires AQL 1.5 for examination gloves and 0.65 for surgical gloves.
Chemical and Micro-organism Protection
Permeation, degradation, leak and virus testing behind the Type A, B or C rating. General glove requirements under EN ISO 21420.
Device Traceability
Basic UDI-DI and UDI-DI shown against each F. Bosch product code.
Labelling and Instructions for Use
Symbols to EN ISO 15223-1:2021. English, German, French and Greek, with additional languages prepared where required.
Material Safety
SVHC screening and restricted-substance testing, matched to each product's material.
Food Contact
Declarations and migration testing for food-contact products, including Regulation (EU) 10/2011 for plastics.
Testing by SGS, TÜV SÜD, SATRA and other accredited laboratories, as applicable to each product.
Independent Assessment
Serious compliance needs more than our own word.
- MDSS GmbHEU Authorised RepresentativeMedical devices · Hannover
- Continental Medical B.V.EU Authorised RepresentativeSurgical gloves · Rotterdam
- BSI Group The Netherlands B.V.Notified Body 2797MDR conformity assessment, where required
- SATRA Technology Europe LimitedNotified Body 2777PPE EU type-examination
- CentrocotNotified Body 0624Protective clothing, including Category III
- Bureau Veritas Hong Kong LimitedCertification BodyISO 13485:2016 quality-management system
For EU Importers
Your obligations stay yours. The paperwork shouldn't slow you down.
MDR Article 13 sets out what an EU importer must verify. Here is what we provide for each step.
Declaration of Conformity and regulatory documentation
CE marking, declaration, manufacturer, Authorised Representative and certificates, before placing on the market
EU Authorised Representative details
Manufacturer and representative information
UDI and EUDAMED product information
Your own importer registration in EUDAMED
Labelling in supported languages
Your destination market's requirements
Batch and product traceability
Records for products you receive and distribute
Storage and transport requirements
Those conditions while products are in your care
Complaint and regulatory contact route
Forwarding complaints, suspected incidents and non-conformities
Product regulatory file
Your importer identification, as MDR requires
Customer Portal
Every document behind your order. In one place.
- Declarations of Conformity
- Certificates
- Test reports
- Batch documentation
- Instructions for use
- Sterilisation certificates
- Shipping documents
Organised by product and order, with the issuer, number and validity on every record.
Standards, issuing organisations and documents vary by product and destination market. The product-specific documentation in the Customer Portal governs.
Report a suspected incident or product complaint to [email protected]. Our team will review it and respond in writing.