“Certification” means different things in different markets
Search for “medical device certification” and you will find three very different things mixed together: FDA marketing authorization, CE marking under the EU Medical Device Regulation, and ISO 13485 certification of a quality management system. Confusing them causes real problems, from misleading marketing claims to launch plans that assume a certificate opens a market it does not.
The short version:
- FDA does not certify medical devices. It clears (510(k)), grants (De Novo) or approves (PMA) them (FDA).
- The EU uses certificates. For most devices above Class I, a notified body audits the manufacturer and issues certificates that allow CE marking.
- ISO 13485 certification is about the company, not the device. A certification body confirms that the quality management system meets the standard.
FDA: clearance and approval, not certification
FDA authorizes devices for marketing through its premarket pathways. Saying a device is “FDA certified” is inaccurate, and saying it is “FDA approved” when it was cleared through a 510(k) is a common misbranding risk. FDA describes PMA as “the most stringent type of device marketing application” (FDA); a 510(k) instead shows substantial equivalence to a predicate.
| What FDA does | Correct term | Pathway | FY2027 standard fee |
|---|---|---|---|
| Determines substantial equivalence | Cleared | 510(k) | $28,653 |
| Classifies a novel low/moderate-risk device | Granted | De Novo | $191,020 |
| Finds reasonable assurance of safety and effectiveness | Approved | PMA | $636,732 |
Fees are from FDA’s FY2027 user fee notice (Federal Register).
FDA also does not certify quality systems. Under the Quality Management System Regulation, effective February 2, 2026, FDA incorporates ISO 13485:2016 by reference but checks compliance through its own inspections (FDA). An ISO 13485 certificate does not exempt you from FDA inspection, and FDA inspections under the QMSR do not follow certification audit procedures (FDA QMSR FAQ).
The one document FDA does issue that is often called a certificate is an export certificate, such as a Certificate to Foreign Government, which some importing countries require as evidence that a device is legally marketed in the US.
The main types of medical device certification compared
| Certification | Issued by | What it covers | Required for |
|---|---|---|---|
| FDA 510(k) clearance / De Novo / PMA approval | FDA | The specific device | US market |
| EU MDR certificate and CE marking | Notified body (certificate); manufacturer affixes CE mark | Device and QMS, depending on route | EU market (most devices above Class I) |
| ISO 13485 certificate | Accredited certification body | The quality management system | Not legally required in the US; expected by many customers and regulators |
| MDSAP certificate / audit report | MDSAP-recognized auditing organization | QMS against requirements of participating regulators | Canada; accepted by FDA, Brazil, Japan and Australia in different ways |
| Electrical safety and testing reports (e.g., IEC 60601) | Test labs, including ASCA-accredited labs | Specific product tests | Evidence for submissions and certificates |
CE marking under the EU MDR
In the EU, the route to CE marking depends on device class. Article 52 of the MDR sets out the conformity assessment procedures, which are detailed in Annexes IX to XI (Advisera):
| EU class | Notified body involvement | Typical route |
|---|---|---|
| Class I (non-sterile, no measuring function, not reusable surgical) | None; manufacturer self-declares | Technical documentation and EU declaration of conformity |
| Class I sterile, measuring or reusable surgical | Limited to those aspects | Annex IX or XI for the relevant aspects |
| Class IIa | Yes | Annex IX (QMS) with technical documentation sampling, or Annex XI |
| Class IIb | Yes | Annex IX with technical documentation assessment (sampling for some devices), or Annex X type examination plus Annex XI |
| Class III | Yes, most stringent | Annex IX with full technical documentation assessment, or Annex X plus XI; clinical evaluation consultation for some devices |
Certificates are not a one-time event. Notified bodies carry out surveillance audits and, under Annex IX section 3.4, unannounced audits at least once every five years (TÜV SÜD). Legacy devices certified under the old directives can stay on the market under transition rules until December 31, 2027 or December 31, 2028 depending on risk class, provided conditions are met. Certificates and devices must also be registered in EUDAMED, where the first modules became mandatory on May 28, 2026 (HPRA).
A wider reform of the MDR and IVDR is progressing, with adoption targeted for mid-2027 (Emergo by UL). Until it is adopted, plan certification timelines on the current rules.
ISO 13485 certification and MDSAP
ISO 13485:2016 certification is issued by an accredited certification body after a stage 1 and stage 2 audit, followed by annual surveillance audits and recertification every three years. In the US it is voluntary, but the QMSR’s incorporation of ISO 13485 means a certified system is a strong starting point for FDA compliance. It is not proof of it.
The Medical Device Single Audit Program (MDSAP) lets one audit cover the requirements of several regulators. Its members are Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and PMDA, and FDA (FDA). FDA’s compliance program states that “Surveillance inspections are not conducted at manufacturers actively enrolled in MDSAP” (FDA CP 7382.850), though for-cause and other inspection types can still occur.
Testing certifications and FDA’s ASCA program
Product testing, such as electrical safety, electromagnetic compatibility and biocompatibility, supports both FDA submissions and EU certificates. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) recognizes accredited test labs for certain standards. AAMI reports that ASCA now has permanent status, about 99 participating labs, and that roughly 90% of submissions using ASCA test reports drew no FDA request for the full test report (AAMI News).
Standards change too: ISO 10993-1, the biocompatibility framework, was revised in November 2025, and FDA has partially recognized the new edition (Exponent).
Certification roadmap for a device sold in the US and EU
- Classify the device in each market; EU and US classes do not always match.
- Build a QMS that meets ISO 13485:2016 and Part 820. Consider MDSAP if you plan to sell in Canada, Brazil, Japan or Australia.
- Plan testing with recognized standards and, where possible, ASCA-accredited labs.
- Prepare the US submission in eSTAR (510(k) or De Novo) or a PMA.
- Prepare EU technical documentation and clinical evaluation; apply to a notified body early, since capacity is limited.
- Register establishments and devices with FDA and actors, devices and certificates in EUDAMED.
- Maintain certificates through surveillance audits, change notifications and postmarket surveillance.
Make certification audits less painful
Notified body and certification audits are document-heavy: technical files, clinical evaluations, risk files and procedures. AI document assessment can check those documents against the MDR, ISO 13485 or QMSR before the auditor does, and cite the passage behind every finding.
Run a sample regulatory document assessment on one technical documentation section. AskDona shows the evidence; your team decides.
FAQ
Does FDA certify medical devices? No. FDA clears, grants or approves devices through the 510(k), De Novo and PMA pathways (FDA). It also issues export certificates for devices legally marketed in the US.
Is ISO 13485 certification required to sell in the US? No, but the QMSR incorporates ISO 13485:2016 requirements, and FDA inspects against them.
Who issues CE marking certificates? Notified bodies designated under the EU MDR issue certificates; the manufacturer then affixes the CE mark. Most Class I devices are self-declared.
Does MDSAP replace FDA inspections? FDA does not conduct routine surveillance inspections at manufacturers actively enrolled in MDSAP, but other inspection types can still happen (FDA CP 7382.850).
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: Device Approvals and Clearances | Regulator | Current | Pathways, PMA quote |
| Federal Register: FY2027 user fees | Regulator | 2026 | Fees |
| FDA: QS Regulation / QMSR | Regulator | 2026 | QMSR |
| FDA: QMSR FAQ | Regulator | 2026 | Certification vs inspection |
| FDA: MDSAP | Regulator | Current | MDSAP members |
| FDA: CP 7382.850 | Regulator | Feb 2, 2026 | MDSAP and inspections |
| Advisera: MDR conformity assessment | Consultancy | Current | Article 52 routes |
| TÜV SÜD: Unannounced audits | Notified body | Current | Five-year unannounced audits |
| HPRA: EUDAMED | Regulator (EU) | 2026 | EUDAMED |
| Emergo by UL: MDR/IVDR revision | Consultancy | Oct 9, 2026 | EU reform |
| AAMI News: ASCA | Standards body | Apr 16, 2026 | ASCA status |
| Exponent: ISO 10993-1 recognition | Consultancy | Jun 5, 2026 | Biocompatibility standard |