What “medical device assessment” means
Before a device reaches patients, someone other than its manufacturer usually assesses whether it meets the rules. In the EU this is called conformity assessment and is often performed by a notified body. In the US, FDA performs its own premarket review and inspections. Around both sit specialized assessments: clinical evaluation, biocompatibility, electrical safety, software and cybersecurity.
This guide explains how those assessments work in 2026 and how to prepare the evidence they rely on.
EU MDR conformity assessment routes
Article 52 of the EU MDR sets the procedures, with detail in Annexes IX to XI (Advisera):
| Annex | Procedure | What is assessed |
|---|---|---|
| IX | Quality management system and technical documentation assessment | The QMS (Chapter I) plus technical documentation (Chapter II), with depth depending on class |
| X | Type examination | A representative sample of the device and its technical documentation |
| XI | Product conformity verification | Production quality assurance (Part A) or product verification (Part B), usually combined with Annex X |
Which routes are available depends on class. Class I devices (except sterile, measuring or reusable surgical instruments) are self-assessed by the manufacturer. Class IIa, IIb and III devices require a notified body, with Class III and certain Class IIb implantables subject to the deepest technical documentation review.
Assessment does not stop at certification. Notified bodies conduct surveillance and, under Annex IX section 3.4, unannounced audits at least once every five years (TÜV SÜD). Certificates and devices must be registered in EUDAMED, where mandatory use of the first modules began May 28, 2026 (HPRA).
EU reform on the horizon
A targeted revision of the MDR and IVDR aims to simplify assessment and reduce bottlenecks. Emergo by UL reports that European Parliament committees voted in favor in September 2026, with adoption targeted for mid-2027 (Emergo by UL). Until then, current transition deadlines apply: December 31, 2027 for higher-risk legacy devices and December 31, 2028 for lower-risk ones.
How the US assesses devices
FDA does not grant market access through third-party certificates. It reviews submissions and inspects manufacturers itself, with a limited 510(k) Third Party Review Program for eligible devices. The main mechanisms:
| US mechanism | What FDA assesses | Notes |
|---|---|---|
| 510(k) | Substantial equivalence to a predicate | eSTAR mandatory; FY2027 fee $28,653 |
| De Novo | Safety and effectiveness of a novel low/moderate-risk device with controls | eSTAR mandatory since Oct 1, 2025 |
| PMA | Safety and effectiveness of a Class III device | ”The most stringent type of device marketing application” (FDA) |
| Recognized consensus standards | Declarations of conformity to FDA-recognized standards | Reduce the data FDA needs to see |
| ASCA | Testing by accredited labs for selected standards | Streamlines review of test reports |
| Inspections (QMSR) | QMS compliance under CP 7382.850 | Six QMS areas (FDA) |
Fees from FDA’s FY2027 notice (Federal Register); eSTAR dates from the CDRH Portal page (FDA).
Specialized assessments that feed both systems
Testing and standards (ASCA)
Most submissions rely on testing to recognized standards for electrical safety, electromagnetic compatibility, biocompatibility and more. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) lets accredited labs perform testing to selected standards with streamlined FDA review. AAMI reports that ASCA now has permanent status, about 99 participating labs, and that roughly 90% of submissions using ASCA testing drew no FDA request for full test reports (AAMI News).
Biocompatibility
ISO 10993-1, the framework for biological evaluation, was revised and published on November 18, 2025 (ISO). FDA has partially recognized the 2025 edition, excluding clause 6.9 (Exponent). Biological evaluation plans written to the 2018 edition should be reviewed for gaps, especially for devices in development.
Clinical evaluation
The EU MDR requires a clinical evaluation for every device (Article 61 and Annex XIV), updated with post-market clinical follow-up. In the US, clinical data requirements depend on the pathway: often limited for 510(k)s, substantial for PMAs.
Software, cybersecurity and AI
For cyber devices, FDA assesses cybersecurity under section 524B of the FD&C Act, using guidance most recently updated February 3, 2026 (FDA). AI-enabled devices may include a predetermined change control plan so FDA can assess future model changes up front (FDA). In the EU, AI Act obligations for AI in medical devices apply from August 2, 2028 and will add AI-specific requirements to conformity assessment (Gibson Dunn).
Assessment readiness checklist
Planning
- Device classified in each target market, with rationale documented
- Conformity assessment route (EU) and premarket pathway (US) selected
- Notified body engaged early; capacity and timelines confirmed
- Standards list uses current, recognized or harmonized editions (including ISO 10993-1:2025 where relevant)
Evidence
- Technical documentation complete against MDR Annex II and III
- General safety and performance requirements checklist with evidence for each item
- Testing performed by accredited labs, using ASCA where available
- Clinical evaluation and PMCF plan current
- Risk management file links hazards, controls and verification
- Cybersecurity and AI documentation complete where applicable
Quality system
- QMS meets ISO 13485:2016 and, for the US, QMSR
- Ready for unannounced notified body audits and FDA inspections
- EUDAMED and GUDID registrations consistent with technical documentation
Run your own assessment first
Every assessor, whether a notified body or FDA reviewer, works through your documents requirement by requirement. AskDona does the same before they do: it assesses technical documentation, test reports and procedures against MDR, ISO 13485 or QMSR requirements and cites the passage behind every finding.
Run a sample regulatory document assessment on one technical file section or GSPR checklist. AskDona shows the evidence; your team decides.
FAQ
What is a medical device conformity assessment? The process of demonstrating that a device meets regulatory requirements. Under the EU MDR, it follows routes in Annexes IX to XI and usually involves a notified body (Advisera).
Who assesses medical devices in the US? FDA, through 510(k), De Novo and PMA review and QMSR inspections. Accredited labs can test devices under the ASCA program.
What is ASCA? FDA’s Accreditation Scheme for Conformity Assessment, which recognizes accredited test labs for selected standards to streamline review (AAMI News).
Has ISO 10993-1 changed? Yes. A new edition was published November 18, 2025, and FDA has partially recognized it (Exponent).
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| Advisera: MDR conformity assessment | Consultancy | Current | Article 52 routes |
| TÜV SÜD: Unannounced audits | Notified body | Current | Annex IX 3.4 |
| HPRA: EUDAMED | Regulator (EU) | 2026 | EUDAMED |
| Emergo by UL: MDR/IVDR revision | Consultancy | Oct 9, 2026 | EU reform |
| FDA: Device Approvals and Clearances | Regulator | Current | Pathways |
| FDA: CP 7382.850 | Regulator | Feb 2, 2026 | Inspections |
| Federal Register: FY2027 user fees | Regulator | 2026 | Fees |
| FDA: CDRH Portal | Regulator | Current | eSTAR |
| AAMI News: ASCA | Standards body | Apr 16, 2026 | ASCA |
| ISO: ISO 10993-1:2025 | Standards body | Nov 18, 2025 | Biocompatibility |
| Exponent: ISO 10993-1 recognition | Consultancy | Jun 5, 2026 | FDA recognition |
| FDA: Cybersecurity guidance | Regulator guidance | Feb 3, 2026 | Section 524B |
| FDA: PCCP guidance for AI | Regulator guidance | Final | AI changes |
| Gibson Dunn: AI Act Omnibus | Law firm | 2026 | AI Act dates |