Medical devices · Global

ISO 13485:2016 — Medical Devices Quality Management System Compliance

ISO 13485:2016 — Medical Devices Quality Management System is issued by ISO / FDA / EU MDR and has applied since 2016-03-01. It applies to products sold in Global. Below: what it covers, which products trigger it, the documents a supplier must provide, and how Complyra checks a product against it.

Authority: ISO / FDA / EU MDR
Jurisdiction: Global
Regions: Global
Effective: 2016-03-01
Evidence renewal: every 1095 days
Official source: https://www.iso.org/standard/59752.html

What ISO 13485:2016 — Medical Devices Quality Management System covers

ISO 13485:2016 — Medical Devices Quality Management System is a medical devices requirement in Global. In Complyra's dataset it is triggered by products in the following categories and by product descriptions that mention the keywords listed below.

Product categories affected

medical packaging

Keywords that trigger a check

medical device
medical
surgical
diagnostic
implant
sterile
hospital
clinical
pharmaceutical packaging
IVD
orthopaedic

Who it applies to

Buyers importing or placing the affected products on the market in Global, and the suppliers who manufacture or distribute them. In a procurement workflow the buyer is responsible for obtaining the evidence listed below from the supplier before the order is placed.

Consequences of non-compliance recorded in the dataset: Market withdrawal, criminal prosecution, €10M+ fines

Supplier requirements and compliance evidence

Documents a supplier should be able to provide for products in scope. Ask for these in the RFQ rather than after the goods ship.

Document
ISO 13485 QMS Certificate from Notified Body
Technical File / Design Dossier
Risk Management File (ISO 14971)
Clinical Evaluation Report (CER)
Post-Market Surveillance Plan
Unique Device Identification (UDI) registration
Declaration of Conformity (EU MDR 2017/745)

Certification types recorded for this regulation

ISO 13485 QMS
CE Mark MDR
FDA 510K or PMA

How Complyra checks ISO 13485:2016 — Medical Devices Quality Management System

When a product is searched or sourced in Complyra, its category and description are matched against the trigger categories and keywords above. If ISO 13485:2016 — Medical Devices Quality Management System applies, the product and its supplier are checked against the materials, substance limits and required documents recorded for the regulation, and the result is shown alongside the supplier match, before an RFQ is generated.

Suppliers on Complyra register and upload certifications that are reviewed by an administrator; see supplier compliance for how that review works and supplier sourcing for how compliant suppliers are found and matched.

Complyra checks product and supplier information against regulatory requirements to support procurement decisions. It does not issue certifications or guarantee legal compliance; final responsibility for compliance remains with the buyer and supplier.