Medical device and diagnostic manufacturers face increasingly complex regulatory landscapes — especially when bringing products to both the United States and the European Union.
While the U.S. FDA and the EU MDR/IVDR frameworks share the same ultimate goal, ensuring product safety, performance, and patient protection, their regulatory pathways, documentation requirements, and oversight mechanisms differ significantly.
Understanding these differences is key to planning global market strategies, avoiding delays, and maintaining compliance across jurisdictions.
1. Regulatory Authorities and Frameworks
United States: FDA Oversight
In the U.S., medical devices and diagnostics are regulated by the Food and Drug Administration (FDA) under:
– 21 CFR Part 807 – Establishment registration and device listing
– 21 CFR Part 820 – Quality System Regulation (QSR)
– 21 CFR Part 809 – In vitro diagnostic (IVD) products
– 21 CFR Part 801 – Labeling requirements
The FDA’s regulatory framework emphasizes premarket review, quality system compliance, and postmarket vigilance.
European Union: Notified Body Oversight
In the EU, devices and IVDs fall under:
– MDR (EU 2017/745) – Medical Device Regulation
– IVDR (EU 2017/746) – In Vitro Diagnostic Regulation
These regulations replaced the previous MDD and IVDD directives and introduced stricter requirements for clinical evidence, documentation, and postmarket surveillance.
Compliance is assessed by Notified Bodies, independent organizations designated by EU member states.
2. Device Classification: Similar Goals, Different Systems
Both the FDA and the EU classify devices based on risk — but their categories and thresholds differ.
| Region | Framework | Classes | Key Determinant |
|---|---|---|---|
| U.S. | FDA | Class I, II, III | Risk to patient and intended use |
| EU | MDR | Class I, IIa, IIb, III | Degree of invasiveness, duration of use, and impact on the body |
| EU (IVD) | IVDR | Class A, B, C, D | Based on risk to public health and patient outcomes |
In the U.S., Class I devices may be exempt from premarket review, while Class III devices require a Premarket Approval (PMA).
Under MDR/IVDR, most devices (except Class I) require Notified Body involvement, and IVD classification changes under IVDR mean that ~80–90% of IVDs now require certification — up from ~20% under IVDD.
3. Quality Management System (QMS) Requirements
| Requirement | FDA | EU MDR / IVDR |
|---|---|---|
| QMS Standard | 21 CFR Part 820 (moving toward ISO 13485 alignment under QMSR) | ISO 13485:2016 (mandatory) |
| Risk Management | Required (21 CFR 820.30, 820.100) | Required per ISO 14971:2019 |
| Documentation | Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) | Technical Documentation / Technical File |
| Management Review | Required | Required |
Key difference:
FDA’s QSR focuses on process-based controls, while EU MDR/IVDR explicitly require ISO 13485 certification and risk-based documentation that aligns with ISO 14971.
The FDA’s upcoming Quality Management System Regulation (QMSR) will further harmonize U.S. requirements with ISO 13485, reducing long-term divergence.
4. Clinical and Performance Evidence
FDA
– Relies on clinical trials, bench testing, and predicate devices (for 510(k) submissions).
– PMA submissions require full clinical evidence demonstrating safety and effectiveness.
EU MDR/IVDR
– Requires Clinical Evaluation Reports (CERs) or Performance Evaluation Reports (PERs) aligned with MEDDEV 2.7/1 Rev. 4 and IVDR Annex XIII.
– Emphasizes ongoing clinical evidence generation, not a one-time submission.
Key difference:
The EU places greater emphasis on continuous clinical evaluation throughout the product lifecycle, while FDA’s evidence is typically assessed during premarket review.
5. Premarket Submission Pathways
| Pathway | U.S. FDA | EU MDR / IVDR |
|---|---|---|
| Low-risk Devices | 510(k) or Exempt | Class I Self-Certification |
| Moderate-risk Devices | 510(k) or De Novo | Class IIa/IIb (Notified Body review) |
| High-risk Devices | PMA | Class III (Notified Body + Clinical Evaluation) |
| IVDs | 510(k), PMA, or LDT (if applicable) | Class A–D (Performance Evaluation + NB review) |
6. Postmarket Surveillance and Vigilance
Both frameworks require continuous monitoring of device performance once on the market, but reporting structures differ.
| Activity | FDA | EU MDR / IVDR |
|---|---|---|
| Complaint Handling | 21 CFR 820.198 | Annex III & Postmarket Surveillance Plan |
| Adverse Event Reporting | Medical Device Reporting (MDR) under 21 CFR 803 | Vigilance reporting via EUDAMED (Annex III & XIV) |
| Periodic Updates | Not required unless significant | Periodic Safety Update Report (PSUR) required |
In short: the EU demands more frequent and structured postmarket reporting than the FDA currently does.
7. Labeling, UDI, and Registration
Both the FDA and EU require Unique Device Identifiers (UDIs), but the databases differ:
– U.S.: FDA’s GUDID (Global Unique Device Identification Database)
– EU: EUDAMED (European Database on Medical Devices)
Labeling must be region-specific, include regulatory symbols, and comply with language requirements.
8. Harmonization and Global Strategy
While the FDA and EU systems are distinct, they are gradually moving toward greater alignment through the Medical Device Single Audit Program (MDSAP) and ISO 13485 harmonization.
Still, companies selling globally must tailor documentation and submissions for each authority.
A well-structured global regulatory strategy can streamline compliance by:
– Designing your QMS to meet both FDA QSR and ISO 13485.
– Creating a single technical file that satisfies both FDA and MDR/IVDR expectations.
– Conducting risk assessments and clinical evaluations that support dual submissions.
– FDA and EU MDR/IVDR share the same intent — but differ in structure, terminology, and evidence expectations.
– The EU requires ISO 13485 certification and continuous clinical evaluation; the FDA focuses on premarket review and CAPA-driven oversight.
– Postmarket surveillance is more structured under the EU MDR/IVDR.
– Building an integrated QMS aligned with ISO 13485 helps ensure global compliance.
How Avendium Can Help
At Avendium, we help life science and diagnostic companies navigate the complex regulatory requirements of both FDA and EU markets.
Our experts provide:
– Gap assessments between MDR/IVDR and FDA QSR/QMSR.
– Technical documentation and clinical evaluation support.
– Preparation for Notified Body and FDA inspections.
– Development of global QMS frameworks aligned with ISO 13485, ISO 14971, and 21 CFR Part 820.
– Training for regulatory and quality teams on dual-market compliance.
Whether you’re introducing a new IVD, medical device, or combination product, Avendium ensures your regulatory strategy supports smooth market entry, on both sides of the Atlantic.
Contact us today to strengthen your global compliance approach.