Medical devices · European Union
EU MDR 2017/745 — Medical Device Regulation Compliance
EU MDR 2017/745 — Medical Device Regulation is issued by European Commission / Notified Bodies and has applied since 2021-05-26. It applies to products sold in EU, EEA. Below: what it covers, which products trigger it, the documents a supplier must provide, and how Complyra checks a product against it.
- Authority
- European Commission / Notified Bodies
- Jurisdiction
- European Union
- Regions
- EU, EEA
- Effective
- 2021-05-26
- Evidence renewal
- every 1825 days
- Official source
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
What EU MDR 2017/745 — Medical Device Regulation covers
EU MDR 2017/745 — Medical Device Regulation is a medical devices requirement in European Union. 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
Keywords that trigger a check
Who it applies to
Buyers importing or placing the affected products on the market in EU, EEA, 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 ban, criminal prosecution
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 |
|---|
| CE Certificate under MDR 2017/745 |
| Technical Documentation |
| Clinical Evaluation Report |
| Post-Market Clinical Follow-up Plan |
| EUDAMED registration |
| UDI assignment |
| Serious Incident Reporting SOP |
Certification types recorded for this regulation
How Complyra checks EU MDR 2017/745 — Medical Device Regulation
When a product is searched or sourced in Complyra, its category and description are matched against the trigger categories and keywords above. If EU MDR 2017/745 — Medical Device Regulation 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.
Related regulations
- FDA 510(k) Clearance — Medical Device Premarket Notification
- ISO 13485:2016 — Medical Devices Quality Management System
- CE Marking — European Conformity Marking
- ISO 9001:2015 — Quality Management System
Industries where this regulation applies
- Medical devices and medical supplies — 5 regulations
More
- All regulations in the dataset
- Regulation index (all 47 in one table)
- Free compliance checker — which regulations apply to a product
- RFQ template generator — build a structured RFQ
- The full AI procurement workflow
Check a product against EU MDR 2017/745 — Medical Device Regulation
Describe the product and destination market. Complyra identifies whether this regulation applies and which documents to request from the supplier.