Glossary

Conformity Assessment (CA)

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Conformity Assessment (CA) is the formal set of activities used to demonstrate that a medical device meets the legal safety and performance requirements for a given market. CA may include testing, inspection, auditing, certification, and ongoing surveillance. Outcomes and terminology are jurisdiction-specific: in the EU, successful CA leads to CE marking under Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR); in the U.S., evidence is reviewed by FDA through pathways such as 510(k), De Novo, or PMA rather than a “CE-style” CA certificate.

Testing • Inspection • CertificationJurisdiction-specificMarket access

Jurisdictional frameworks (precise usage)

  • European Union (MDR/IVDR): CA follows defined conformity assessment routes (e.g., MDR Annex IX [QMS + technical documentation], Annex X [type-examination], Annex XI [production quality assurance]). Notified Bodies assess most devices except certain Class I non-sterile/non-measuring devices (self-declaration). Equivalent IVDR routes apply to IVDs (Annexes IX–XI); most IVDs require a Notified Body.
  • United States (FDA): The term “conformity assessment” is not used as the legal market-entry decision. Instead, FDA issues clearance (510(k), 21 CFR 807), De Novo classification (21 CFR 860), or approval (PMA, 21 CFR 814) based on valid scientific evidence. Manufacturers may reference consensus standards (FDA recognition program) to support submissions.
  • United Kingdom: Market access via UKCA marking; assessment by Approved Bodies under UK MDR 2002 (as amended).
  • Australia (TGA): Demonstrate compliance with Essential Principles and an appropriate CA procedure to achieve ARTG inclusion; recognized evidence may include EU certificates for certain pathways.
  • Canada (Health Canada): Device licence (Classes II–IV) requires evidence of compliance with safety/performance and quality system requirements (ISO 13485); MDSAP certificates are used for licensing.
  • Japan (PMDA/MHLW): Higher-risk devices undergo shōnin approval; some lower-risk devices use third-party certification (ninshō) under the PMD Act.

What CA typically covers

  • Technical documentation: device description, intended purpose, risk management (ISO 14971), verification/validation (bench, biocompatibility, sterilization/packaging, EMC/electrical, software/cybersecurity, usability), clinical evaluation/investigation evidence.
  • Quality management system: assessment of QMS suitability (e.g., MDR Article 10 obligations; ISO 13485; U.S. QMSR when applicable).
  • Labeling/IFU and information supplied with the device.
  • Ongoing surveillance: post-market surveillance, vigilance, periodic reporting, and (where applicable) notified-body surveillance audits.

Who performs CA and outcomes

  • EU/UK/AU/JP: Third-party organizations (Notified Bodies, Approved Bodies, CABs) conduct assessments and issue certificates or approvals that enable CE/UKCA/ARTG/NHI outcomes.
  • U.S.: FDA directly reviews submissions and issues clearance/approval orders; third-party review is limited to specific programs and does not replace FDA’s decision.
  • Self-declaration (limited cases): Certain lower-risk devices (e.g., EU Class I non-sterile/non-measuring) may use self-declaration, but must still maintain complete technical documentation and PMS.

Quick checklist

  • Identify the correct route (EU Annex, FDA pathway, UKCA, ARTG, Japan).
  • Map requirements → objective evidence (GSPR/Essential Principles, standards, reports).
  • Ensure QMS readiness (ISO 13485; supplier controls; production validations).
  • Align labeling/IFU with risk controls and claims.
  • Define post-market plans (PMS/PMCF, vigilance reporting).

Conformity Assessment — FAQs

Is CA the same as FDA approval?
No. In the U.S., FDA renders clearance/approval decisions via 510(k), De Novo, or PMA. “Conformity assessment” in the CE-style sense is not the U.S. legal outcome.
Do all devices need a Notified Body in the EU?
No. Some Class I non-sterile/non-measuring devices may self-declare. Most other devices (and most IVDs under IVDR) require a Notified Body.
Does CA include clinical data?
Often yes. Where non-clinical evidence is insufficient, clinical evaluation or investigation is required (e.g., MDR Annex XIV; FDA clinical studies for PMA).
Is passing a test to a standard enough?
Not alone. Standards support CA but do not replace the need to meet all legal requirements (GSPR/Essential Principles, risk management, labeling, PMS).
Who maintains CA documentation?
The manufacturer. Technical documentation and certificates must be kept current and available to regulators and assessment bodies; surveillance activities verify ongoing conformity.