Global Medical Device Regulations
Every market. Every device. One regulatory picture.
EU MDR, IVDR, FDA QMSR, UDI, MDSAP, NMPA — medical device compliance means tracking dozens of moving frameworks across every market you sell in. Certean monitors them all daily, maps changes to your specific devices, and keeps your technical documentation audit-ready.
- EU MDR, IVDR, FDA, and global registration requirements mapped per device and market
- Real-time alerts when guidance, harmonized standards, or national rules change
- Technical documentation, declarations, and certificates tracked through their lifecycle
- UDI, labelling, and post-market surveillance obligations monitored per device class
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Key Milestones
Requirements
The frameworks your devices
have to satisfy
EU MDR & IVDR
Regulation (EU) 2017/745 and 2017/746 govern every device sold in the EU — classification, conformity assessment, clinical evaluation, and the legacy-device transition deadlines running through 2027-2028.
FDA requirements
From the QMSR (harmonized with ISO 13485, in effect since February 2026) to 510(k), De Novo, and PMA pathways — US market access runs on documentation discipline and change control.
QMS & risk standards
ISO 13485 quality management, ISO 14971 risk management, IEC 60601 electrical safety, and IEC 62304 software lifecycle — the standards baseline auditors and notified bodies expect.
UDI & EUDAMED
Unique Device Identification requirements across FDA GUDID and EU EUDAMED, with data submission obligations phasing in by device class and module.
Global registrations
MDSAP audits covering the US, Canada, Brazil, Australia, and Japan, plus national pathways like China NMPA, Japan PMDA, and UKCA under the evolving UK MDR.
Post-market surveillance
PMS plans, periodic safety update reports, vigilance reporting, and trend analysis — continuous obligations that outlast the initial approval for every device on the market.
FAQ
Medical device compliance, answered
- What regulations apply to medical devices sold globally?
- In the EU, the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746). In the US, FDA requirements including the QMSR (21 CFR 820, harmonized with ISO 13485) and premarket pathways such as 510(k) and PMA. Most other major markets — Canada, Brazil, Australia, Japan, China, the UK — run their own registration systems, many aligned through MDSAP or ISO 13485. Certean maps which requirements apply to each device in each target market.
- How does Certean help medical device manufacturers stay compliant?
- Certean monitors regulatory sources across 150+ markets daily and alerts your team when MDR guidance, harmonized standards, FDA rules, or national registration requirements change — mapped to the specific devices and markets affected. The platform tracks technical documentation, declarations of conformity, and certificates through their lifecycle, and keeps post-market surveillance obligations visible per device.
- Does Certean replace a QMS like ISO 13485?
- No — Certean complements your QMS. Your quality management system governs how you design and manufacture devices; Certean governs regulatory intelligence and market access: which requirements apply where, what changed, which evidence is needed, and whether your documentation and certificates are current across every market you sell in.
- Can Certean track the EU MDR legacy device deadlines?
- Yes. The extended MDR transition periods for legacy devices run to the end of 2027 for higher-risk devices and the end of 2028 for lower-risk classes, subject to conditions like having a notified body agreement in place. Certean tracks these milestones per device, flags the conditions attached to each deadline, and alerts your team as dates approach.
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See your devices against every market
Book a 30-minute demo and we'll walk through your device classes, target markets, and the deadlines that apply to you.
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