Product Safety & Market Access Certifications
Of IVDs up-classified under IVDR, now requiring Notified Body involvement
Average Notified Body certification review timeline
EUDAMED mandatory registration deadline for new devices
Regulation Overview
EU MDR/IVDR compliance is the EU's comprehensive regulatory framework for medical devices and in vitro diagnostics. These regulations replaced the former Medical Device Directives (MDD, AIMDD) and the In Vitro Diagnostic Directive (IVDD), introducing substantially stricter requirements for clinical evidence, post-market surveillance, quality management systems, and supply chain documentation.
Under the former IVDD, approximately 8% of IVDs required Notified Body involvement. Under IVDR, that figure rises to approximately 80%. Notified Body capacity remains constrained—only around 40 are designated under MDR, and fewer under IVDR. Average certification reviews run 13–18 months. EUDAMED registration becomes mandatory May 28, 2026, requiring actor registration, UDI/device data, and certificate uploads.
EU MDR/IVDR compliance requires substance-level data on materials in contact with patients—intersecting with chemical regulations like REACH and RoHS for restricted substances in device components. When device designs change or suppliers are substituted, the entire technical documentation package may require reassessment.
Medical device and IVD manufacturers placing devices on the EU/EEA market
Authorized representatives acting on behalf of non-EU manufacturers
Importers placing medical devices or IVDs on the EU market
Distributors handling devices within the EU supply chain
Component and material suppliers providing evidence for device technical files
Contract manufacturers and sterilization service providers
Key Thresholds
Only around 40 Notified Bodies are designated under MDR, and fewer under IVDR. Certification review timelines average 13–18 months—and your submission is queued behind thousands of legacy device transitions. Every incomplete document—a missing supplier material certificate, an outdated biocompatibility report—sends your application back for revision and resets the clock.
EUDAMED registration becomes mandatory May 28, 2026. Your organization needs actor registration, UDI-DI creation for every device, and certificate data uploads—across a portfolio of 500 devices from three manufacturing sites. Device data lives in spreadsheets, PLM systems, and email chains. Without a centralized compliance data backbone, reconciling regulatory data across systems takes months.
Technical documentation under Annex II requires documented evidence for every material in patient-contact components—biocompatibility data, chemical composition, REACH and RoHS substance compliance. Your device uses 40 components from 25 suppliers. Supplier 1 provides a certificate of analysis. Supplier 2 sends a material data sheet in the wrong format. Supplier 3 hasn't responded. Without multi-tier supply chain transparency, your technical file has gaps that block Notified Body review.
Thousands of legacy devices must transition from MDD/IVDD to MDR/IVDR before deadline convergence in 2027–2028. Each legacy device requires a full technical documentation package rebuilt to MDR/IVDR standards, including updated clinical evaluations and supplier evidence. For organizations with hundreds of SKUs, the documentation burden overwhelms teams still relying on manual processes.
Certivo In Action
Certivo in Action — EU MDR/IVDR Workflow
Features Tabs
Medical Devices & Equipment
Your Pain Point
Complex BOMs; multi-tier supplier evidence for Annex II; Notified Body documentation requirements; legacy transition
Pharmaceuticals & Biotech
Your Pain Point
Companion diagnostics under IVDR; drug-device combination products; clinical evidence demands
Electronics Manufacturing
Your Pain Point
Electronic components in Class IIa/IIb active devices; RoHS/REACH intersection with MDR material requirements
Chemical Manufacturing
Your Pain Point
Raw material and chemical substance evidence for device manufacturers; biocompatibility data requirements
Industrial Machinery & Heavy Equipment
Your Pain Point
Sterilization equipment and cleanroom systems subject to MDR as accessories; supplier evidence for process validation
Consumer Goods
Your Pain Point
Borderline products (e.g., cosmetic devices reclassified as medical devices under MDR Annex XVI)
From Manual Evidence Compilation to Exception Management
CORA extracts supplier material data and certificate information automatically through AI-native compliance automation. Your team focuses on exceptions requiring human judgment—not manual document chasing across supplier tiers.
Notified Body Submission Acceleration
Generate complete, structured supplier evidence packages for Annex II technical documentation in hours—not the months of manual compilation that delay certification timelines.
Proactive EU MDR/IVDR Compliance Readiness
When supplier certificates expire, material compositions change, or REACH/RoHS regulations update, Certivo reassesses your device portfolio instantly. Know which evidence gaps exist before Notified Body audits—through continuous compliance monitoring and audit readiness.
Frequently Asked Questions
What companies and products are subject to EU MDR/IVDR compliance obligations?
Any company placing medical devices or in vitro diagnostic devices on the EU/EEA market must comply—including manufacturers, authorized representatives, importers, and distributors. MDR covers devices classified from Class I through Class III; IVDR covers IVDs from Class A through Class D. The regulation extends to component and material suppliers who must provide evidence supporting the manufacturer's technical documentation.
What are the consequences of failing to meet EU MDR/IVDR deadlines?
Without valid CE marking under MDR/IVDR, a medical device cannot legally be sold in any EU/EEA market. Legacy devices that miss transition deadlines lose their market authorization—several manufacturers have already withdrawn devices due to inability to complete certification in time. Notified Body capacity constraints mean delayed submissions face queues of 13–18 months or longer.
How does Certivo manage supplier evidence for MDR/IVDR technical documentation?
CORA launches targeted evidence campaigns to material and component suppliers across all tiers, following up automatically in suppliers' native languages. Certivo accepts any evidence format—Certificates of Analysis, biocompatibility reports, material composition data, REACH declarations. AI document parsing and certificate validation extracts structured data, maps it to device-level requirements, and flags gaps automatically.
Does Certivo validate against MDR/IVDR alongside REACH, RoHS, and other chemical frameworks?
Yes. Certivo validates supplier material evidence against EU MDR/IVDR requirements, REACH SVHC thresholds, RoHS restricted substances, and emerging PFAS regulations simultaneously. A single supplier submission is validated across multiple frameworks through BOM-level compliance intelligence—eliminating duplicate evidence collection campaigns and ensuring material compliance data supports both device certification and chemical regulation obligations.
How does Certivo support EUDAMED preparation and ongoing compliance monitoring?
Certivo centralizes device-level data including UDI information, supplier evidence status, certificate validity, and material composition across your entire portfolio. When EUDAMED mandatory registration deadlines approach, Certivo provides structured data exports aligned with EUDAMED requirements. The platform continuously monitors certificate expirations, regulatory updates through regulatory intelligence and horizon scanning, and supplier evidence freshness—ensuring continuous compliance monitoring and audit readiness throughout each device's lifecycle.