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Medical Device Certifications & Regulatory Requirements

What the main standards, conformity marks, approvals, registrations and licences mean, and which apply in 20 markets. Search an entry or browse by category below.

Marks, standards and authorities at a glance

Badges are text labels made by SurgiFacts for navigation. They are not official logos or marks and do not imply endorsement, certification or approval by any body.

Quality management & ISO standards

Standards for how a company runs its quality system and manages risk. A QMS certificate covers the organisation, not a product, and is not a market authorization.

Product safety & technical standards

Technical standards describe how to design, test or validate a device. Meeting one is evidence toward legal requirements; it is not itself an approval or a certificate to sell.

International regulatory authorities

Regulators grant the legal permission to supply a device. Depending on the market and risk class that is a clearance or approval, a registration or listing, and often a licence for the company itself.

Regional conformity frameworks

Conformity assessment shows a device meets the rules. A conformity marking is affixed by the manufacturer after that assessment; it is not a certificate issued to the product by a regulator.

Country and regional requirements

The framework and main requirements for each market, after the international standards. Open an entry for scope, typical documentation, process and official sources. Related: Surgical instrument manufacturers · Medical AI companies

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9 entries

European Union / EEA

European Union / EEAImporter or Distributor RequirementsLabeling and TraceabilityPost-Market Surveillance

EU medical device regulatory framework (MDR 2017/745 and IVDR 2017/746) (EU MDR / IVDR)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.

Purpose

Sets common safety and performance rules for medical devices and in vitro diagnostics placed on the EU/EEA market, and the obligations of manufacturers and other economic operators across the device life cycle.

Who it applies to

Manufacturers (EU and non-EU), authorised representatives, importers, distributors and notified bodies dealing with devices placed on the EU/EEA market. Northern Ireland also applies these EU rules.

Applicable products

General medical devices and accessories (MDR) and in vitro diagnostic devices (IVDR). Some products without a medical purpose listed in MDR Annex XVI are also covered.

Classification

MDR: Class I (incl. Is sterile, Im measuring, Ir reusable surgical instruments), IIa, IIb, III. IVDR: Class A, B, C, D. Classes are set by the rules in MDR Annex VIII / IVDR Annex VIII.

General requirements

  • Classify the device under the applicable Annex VIII rules.
  • Meet the General Safety and Performance Requirements (Annex I).
  • Follow the conformity assessment procedure for the class; a notified body is needed for all classes except Class I (non-sterile, non-measuring, non-reusable-surgical) and Class A non-sterile IVDs.
  • Draw up technical documentation, an EU Declaration of Conformity and affix the CE mark.
  • Operate a quality management system, post-market surveillance and vigilance, and UDI/EUDAMED registration.
  • Non-EU manufacturers must designate an EU authorised representative.

Typical documentation

  • Technical documentation (Annexes II and III)
  • EU Declaration of Conformity
  • Clinical evaluation (MDR) or performance evaluation (IVDR)
  • Labelling and instructions for use
  • Notified body certificates where required

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Classify, implement QMS and technical documentation, complete the conformity assessment (self-declaration or notified body), sign the Declaration of Conformity, CE mark, register in EUDAMED and then maintain post-market obligations.

Important notes

  • CE marking is not issued by the EU or by a notified body; the manufacturer affixes it after completing conformity assessment.
  • Many devices certified under the old Directives (MDD/AIMDD) can still be placed on the market under the extended transitional provisions of Regulation (EU) 2023/607, subject to conditions.
  • ISO 13485 is a harmonised route to show QMS conformity but the legal requirement is the MDR/IVDR QMS obligation itself.

Points still being verified

  • The Commission proposed a targeted revision/simplification of MDR and IVDR on 16 December 2025 (COM(2025) 1023); it is before the European Parliament and Council and could change conformity assessment, documentation and certification rules. Re-check before publishing.
Official sources (5)

Last verified 29 October 2026

European Union / EEAQuality Management StandardsRegulatory ApprovalRisk Management Standards

MDR device classification and conformity assessment routes (incl. notified bodies) (MDR Annex VIII / IX-XI)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Risk class decides the MDR conformity route. Class I can self-declare, except sterile, measuring and reusable surgical (Ir) devices, which need a notified body for those aspects.

Purpose

Ensures the depth of independent assessment matches the device risk before CE marking.

Who it applies to

Manufacturers placing general medical devices on the EU/EEA market under the MDR.

Applicable products

All MDR devices. Legacy devices still covered by Directive certificates under the transitional provisions follow those certificates until they move to MDR.

Classification

Class I, Is, Im, Ir, IIa, IIb, III (MDR Annex VIII, 22 rules). Under Rule 6, surgically invasive transient-use devices are IIa, but reusable surgical instruments are Class I.

General requirements

  • Apply Annex VIII classification rules; if several rules apply, the strictest applies.
  • Class I (not sterile, not measuring, not reusable surgical): manufacturer self-declares conformity (Annex II/III documentation, Article 52(7)).
  • Class Is/Im/Ir: notified body involvement limited to sterility, metrology, or for Ir the reuse aspects (cleaning, disinfection, sterilisation, maintenance, functional testing and related instructions).
  • Class IIa, IIb, III: notified body conformity assessment (typically QMS plus technical documentation assessment under Annex IX, or Annex X/XI options).
  • Choose a notified body designated under the MDR for the relevant device codes (listed in the Commission NANDO database).

Typical documentation

  • Classification rationale
  • QMS documentation
  • Technical documentation for notified body review where applicable
  • Reprocessing instructions and validation evidence for reusable surgical instruments

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Determine the class, select the Annex IX-XI route allowed for that class, apply to a designated notified body where required, and obtain certificates before CE marking.

Important notes

  • Reusable surgical instruments (e.g. forceps, scissors) are typically Class Ir under the MDR; the notified body assesses the reuse aspects only, not the whole device. Single-use transient surgically invasive instruments are generally Class IIa under Rule 6.
  • Notified bodies are not needed for all devices; plain Class I devices are self-declared.
  • A notified body certificate is device/scope specific, not a general company 'CE certificate'.

Points still being verified

  • The Commission proposed a targeted revision/simplification of MDR and IVDR on 16 December 2025 (COM(2025) 1023); it is before the European Parliament and Council and could change conformity assessment, documentation and certification rules. Re-check before publishing.
  • Article 52(7) and Rule 6 wording confirmed via MDCG 2019-15 and EC UDI Helpdesk summaries; EUR-Lex text could not be fetched directly during research - spot-check the article text.
Official sources (4)

Last verified 29 October 2026

European Union / EEABiocompatibilityLabeling and TraceabilityRisk Management Standards

MDR technical documentation and clinical evaluation (MDR Annex II, III, XIV)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Every MDR device needs technical documentation proving it meets Annex I, plus a clinical evaluation proportionate to its risk, kept up to date across its life cycle.

Purpose

Provides the evidence that a device is safe and performs as intended and supports the Declaration of Conformity.

Who it applies to

All manufacturers of MDR devices, including Class I self-declared devices.

Applicable products

All MDR devices; depth of clinical data depends on class, novelty and claims. Implantable and Class III devices generally need clinical investigations, subject to MDR exemptions.

Classification

Applies to all classes; notified body review of the documentation varies by class.

General requirements

  • Prepare technical documentation per Annex II (device description, labelling, design and manufacturing, GSPR checklist, risk management, verification and validation).
  • Prepare post-market surveillance documentation per Annex III.
  • Perform and document a clinical evaluation (Article 61 and Annex XIV), updated with post-market data.
  • Keep documentation available to competent authorities.

Typical documentation

  • Device description and specifications
  • GSPR checklist with standards applied
  • Risk management file
  • Biocompatibility, sterilisation/reprocessing and performance test reports where relevant
  • Clinical evaluation plan and report
  • Labelling and IFU

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Compile and maintain the file during design and throughout the market life; update the clinical evaluation with PMS and PMCF findings.

Important notes

  • For reusable instruments, validated reprocessing instructions (cleaning, disinfection, sterilisation) are part of the evidence; EN ISO 17664 is commonly used.
  • Equivalence claims must meet MDR criteria; this area is targeted by the 2025 revision proposal.

Points still being verified

  • The Commission proposed a targeted revision/simplification of MDR and IVDR on 16 December 2025 (COM(2025) 1023); it is before the European Parliament and Council and could change conformity assessment, documentation and certification rules. Re-check before publishing.
Official sources (2)

Last verified 29 October 2026

European Union / EEALabeling and TraceabilityProduct Certification or Conformity Marking

CE marking and EU Declaration of Conformity (medical devices) (CE / DoC)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

The manufacturer signs an EU Declaration of Conformity and affixes the CE mark (with notified body number where one was involved) before placing a device on the EU market.

Purpose

Shows the manufacturer has completed the required conformity assessment and takes responsibility for compliance.

Who it applies to

Manufacturers of MDR and IVDR devices, except custom-made and investigational devices.

Applicable products

All devices placed on the EU/EEA market apart from custom-made devices and devices for clinical investigation/performance studies.

Classification

All classes; the notified body identification number accompanies the CE mark when a notified body took part.

General requirements

  • Complete the applicable conformity assessment first.
  • Draw up an EU Declaration of Conformity with the content of Annex IV, kept updated.
  • Affix the CE mark visibly, legibly and indelibly on the device or packaging and IFU as required.
  • Include the notified body number where applicable.

Typical documentation

  • EU Declaration of Conformity
  • Supporting technical documentation and certificates

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Sign the Declaration, apply the mark and keep both available for authorities.

Important notes

  • There is no official EU 'CE certificate' issued to companies; marketing claims of 'CE certified company' are misleading.
  • Customs, distributors and importers check for CE marking and documents.
Official sources (2)

Last verified 29 October 2026

European Union / EEAImporter or Distributor RequirementsManufacturer or Establishment LicensingProduct Registration or Listing

EU economic operator obligations: authorised representative, importer, distributor, PRRC (EU AR / PRRC)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Non-EU manufacturers must appoint an EU authorised representative; importers and distributors have verification duties; a PRRC must be available.

Purpose

Gives authorities an accountable party in the EU and spreads compliance checks along the supply chain.

Who it applies to

Non-EU manufacturers, EU authorised representatives, importers and distributors of MDR/IVDR devices.

Applicable products

All MDR and IVDR devices placed on the EU/EEA market.

General requirements

  • Non-EU manufacturer: designate a single EU authorised representative by written mandate (Article 11).
  • Manufacturer and authorised representative: have a person responsible for regulatory compliance (PRRC) available (Article 15; micro and small enterprises may have one permanently and continuously at their disposal).
  • Importer: verify CE marking, DoC, manufacturer/AR identification, labelling and UDI; add its own details to the device/packaging; register in EUDAMED (Article 13).
  • Distributor: verify CE marking, labelling, IFU and importer details; keep complaint and traceability records (Article 14).
  • Inform the competent authority in advance of an interruption or discontinuation of supply that could cause serious harm (Article 10a, applying from 10 January 2025).

Typical documentation

  • Written mandate with the authorised representative
  • Copies of DoC and certificates
  • Supply chain traceability records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint the AR before placing devices on the market, record actors in EUDAMED and agree responsibilities in supply contracts.

Important notes

  • Exporters from outside the EU (e.g. Pakistan, India, China) cannot place devices on the EU market without an EU authorised representative.
  • A distributor or importer that changes labelling or intended purpose may take on manufacturer obligations (Article 16).

Points still being verified

  • Article 10a application date (10 January 2025) taken from secondary summaries of Regulation (EU) 2024/1860 and Commission Q&A; confirm on EUR-Lex.
Official sources (3)

Last verified 29 October 2026

European Union / EEALabeling and TraceabilityProduct Registration or Listing

EU UDI system, EUDAMED registration and device labelling (UDI / EUDAMED)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Devices need a UDI and Annex I labelling; four EUDAMED modules (actors, UDI/devices, certificates, market surveillance) became mandatory on 28 May 2026.

Purpose

Improves traceability, transparency and recall effectiveness across the EU.

Who it applies to

Manufacturers, authorised representatives, importers and system/procedure pack producers; notified bodies for certificate data.

Applicable products

All MDR/IVDR devices other than custom-made and investigational devices; legacy devices still placed on the market must also be registered.

Classification

Applies to all classes; UDI carrier placement deadlines were phased by class under the MDR.

General requirements

  • Register as an actor in EUDAMED and obtain a Single Registration Number (SRN).
  • Assign Basic UDI-DI and UDI-DI through an EU-designated issuing entity and register device data in the UDI/Device module.
  • Place UDI carriers on labels/packaging; reusable devices needing reprocessing must carry a UDI carrier on the device itself (with MDR transition dates by class).
  • Provide label and IFU information required by MDR Annex I Chapter III, in languages required by Member States.

Typical documentation

  • SRN
  • UDI-DI and Basic UDI-DI records
  • Labels and IFU

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Register actors, then devices, before placing new devices on the market. Commission Decision (EU) 2025/2371 (OJ 27 November 2025) declared four modules functional, triggering mandatory use six months later.

Important notes

  • Mandatory since 28 May 2026: Actor registration, UDI/Device registration, Notified Bodies and Certificates, Market Surveillance.
  • Vigilance/PMS and Clinical Investigation modules are not yet mandatory; vigilance reporting still follows national routes.
  • Devices already on the market before mandatory use have a transition window to be registered (reported as ending late November 2026 - check the Commission timeline PDFs).

Points still being verified

  • Exact deadline for registering devices already on the market before 28 May 2026 (reported as 27 November 2026 by secondary sources) not confirmed in the Commission page text - check the Commission timeline PDFs.
  • Remaining EUDAMED modules (vigilance, clinical investigations) still under development - status will change.
Official sources (3)

Last verified 29 October 2026

European Union / EEAPost-Market Surveillance

EU post-market surveillance and vigilance (MDR/IVDR) (PMS / vigilance)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Manufacturers must run a post-market surveillance system, report serious incidents and field safety corrective actions, and produce PMS reports or PSURs by class.

Purpose

Detects safety and performance problems after market entry and drives corrective action.

Who it applies to

All MDR/IVDR manufacturers; importers and distributors must pass on complaints and cooperate.

Applicable products

All devices on the EU market, including legacy devices under transitional provisions (MDR PMS/vigilance rules apply to them).

Classification

Class I: PMS report. Class IIa, IIb, III: periodic safety update report (PSUR) with frequency by class.

General requirements

  • Plan and run PMS proportionate to risk (Articles 83-86, Annex III).
  • Report serious incidents and field safety corrective actions to competent authorities (Article 87 onwards).
  • Trend reporting of non-serious incidents with significant increases.
  • Feed PMS results into risk management, clinical evaluation and corrective actions.

Typical documentation

  • PMS plan
  • PMS report or PSUR
  • Vigilance records and field safety notices
  • Complaint files

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Collect and analyse post-market data continuously and report incidents within the MDR timelines.

Important notes

  • Until the EUDAMED vigilance module is mandatory, incident reports go to national competent authorities using the Commission's report forms.
Official sources (2)

Last verified 29 October 2026

European Union / EEAQuality Management StandardsRegulatory Approval

MDR transitional provisions for legacy devices (Regulation (EU) 2023/607) (Reg. 2023/607)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

Directive-certified devices may stay on the EU market until 31 Dec 2027 (Class III, IIb implantable) or 31 Dec 2028 (others) if conditions met.

Purpose

Avoids shortages while manufacturers move devices from the old Directives to MDR certification.

Who it applies to

Manufacturers of legacy devices with valid MDD/AIMDD certificates or declarations (including Class I devices up-classified under MDR) meeting the conditions.

Applicable products

Legacy devices only; not new devices or devices with significant changes in design or intended purpose.

Classification

31 December 2027: Class III and Class IIb implantable (with some well-established-technology exceptions). 31 December 2028: other Class IIb, IIa, and Class I devices needing a notified body under MDR.

General requirements

  • Device continues to comply with the Directive and has no significant changes in design or intended purpose.
  • No unacceptable risk to health or safety.
  • MDR-compliant QMS in place by 26 May 2024.
  • Formal application to an MDR notified body lodged by 26 May 2024, and written agreement signed by 26 September 2024.
  • MDR post-market surveillance, vigilance and registration requirements apply.

Typical documentation

  • Valid Directive certificate or declaration
  • Evidence of NB application and written agreement
  • MDR QMS documentation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Maintain legacy compliance while completing MDR certification before the applicable end date.

Important notes

  • Regulation 2023/607 also removed the 'sell-off' date for devices already placed on the market.
  • Class I reusable surgical instruments self-declared under the MDD that now need NB involvement (Ir) are among the up-classified devices covered.

Points still being verified

  • The Commission proposed a targeted revision/simplification of MDR and IVDR on 16 December 2025 (COM(2025) 1023); it is before the European Parliament and Council and could change conformity assessment, documentation and certification rules. Re-check before publishing.
  • Condition dates taken from IGJ (Dutch regulator) summary; confirm against Regulation 2023/607 on EUR-Lex.
Official sources (3)

Last verified 29 October 2026

European Union / EEALabeling and TraceabilityPost-Market SurveillanceProduct Registration or Listing

In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

European Commission (DG SANTE) with national competent authorities of EU/EEA Member States

IVDR applies since 26 May 2022 to IVDs (Classes A-D); most need notified body review, with extended transition for IVDD legacy devices to 2027-2029.

Purpose

Sets safety, performance and evidence rules for in vitro diagnostic devices in the EU.

Who it applies to

Manufacturers, authorised representatives, importers and distributors of IVDs placed on the EU/EEA market.

Applicable products

In vitro diagnostic medical devices and accessories; not relevant to surgical instruments.

Classification

Class A (lowest), B, C, D (highest) under IVDR Annex VIII. Class A non-sterile can be self-declared.

General requirements

  • Classify under Annex VIII; Classes B, C, D and sterile Class A need notified body involvement.
  • Performance evaluation (scientific validity, analytical and clinical performance).
  • Technical documentation, DoC, CE marking, UDI and EUDAMED registration, PMS and vigilance.

Typical documentation

  • Technical documentation
  • Performance evaluation report
  • DoC
  • PMS documentation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Similar to MDR: classify, choose conformity route, obtain notified body certificate where required, CE mark, register and monitor.

Important notes

  • Regulation (EU) 2024/1860 extended IVDD legacy transitions: Class D to 31 Dec 2027, Class C to 31 Dec 2028, Class B and sterile Class A to 31 Dec 2029, subject to QMS and notified body application conditions.

Points still being verified

  • The Commission proposed a targeted revision/simplification of MDR and IVDR on 16 December 2025 (COM(2025) 1023); it is before the European Parliament and Council and could change conformity assessment, documentation and certification rules. Re-check before publishing.
  • IVDR transition dates sourced from HPRA (Irish regulator) table; condition deadlines (2025) differ slightly between secondary sources - confirm on EUR-Lex.
Official sources (3)

Last verified 29 October 2026

Understanding certifications

These terms are not interchangeable. A quality-system certificate, a product authorization, a registration and an establishment licence are different things, granted by different bodies for different purposes. Which ones apply depends on the product, its intended use, its risk class, the company’s activities and the target market.

Product certification

Product certification is a third-party attestation that a specific product meets stated requirements; it is not the same as permission to sell a medical device.

Explains what a product certificate or certification mark means: an independent body has evaluated a product (or product type) against defined requirements, such as a safety standard, and attests that it conforms.

  • A product certificate does not by itself authorize sale of a medical device in a regulated market; regulators have their own authorization routes.
  • Product certification is different from QMS certification (e.g. ISO 13485), which covers the organization's management system, not a specific product.
  • Check that a certificate names the exact model, the standard edition, and the issuing body; certificates cannot be transferred to look-alike products.
  • Example: CE marking of a medical device is a manufacturer's declaration of conformity with EU law, sometimes involving a notified body; it is not a voluntary private certification mark.

Regulatory approval / marketing authorization

Marketing authorization is a regulator's (or legally designated body's) decision allowing a device to be placed on a market; routes and names differ by country.

Explains the legal step that permits a medical device to be sold in a given jurisdiction, and why different terms (clearance, approval, certificate, licence, registration) are not interchangeable.

  • FDA 510(k) clearance, De Novo grant and PMA approval are different outcomes; calling a cleared device 'FDA approved' is inaccurate.
  • FDA establishment registration and device listing are not FDA approval of the establishment or its devices.
  • An establishment licence (permission to operate a business activity) is different from authorization to market a specific device.
  • Authorization in one country does not carry over to another, although some regulators use reliance or abridged routes.

Product registration and listing

Registration and listing put a company or device on a regulator's record; in many systems this is administrative and does not mean the device was reviewed or approved.

Explains that many regulators keep databases of establishments and devices, and that the meaning of 'registration' varies widely: in some countries it is a filing, in others it is the actual marketing authorization.

  • US: FDA establishment registration and device listing are required for many firms, but FDA states that registration does not denote approval of the establishment or its devices.
  • EU: actor and device registration in EUDAMED is a separate obligation from conformity assessment and CE marking.
  • In some countries 'registration' is the name of the marketing authorization itself, so always read what the specific regulator means.
  • A registration number alone is not evidence of quality, safety or performance.

Manufacturer / establishment licensing

An establishment licence permits a company to carry out activities such as manufacturing, importing or distributing devices; it does not authorize any specific device.

Separates permission for a business to operate (a site or activity licence) from permission to market a particular device.

  • Holding an establishment or manufacturing licence does not mean every product the company makes is authorized for sale.
  • Conversely, a device authorization usually does not license an unrelated importer or distributor to handle it.
  • Names differ: licence, permit, registration, manufacturing licence, import licence.

Quality management system (QMS) certification

QMS certification confirms an organization's management system meets a standard such as ISO 13485; it does not certify or authorize any individual product.

Explains what an ISO 13485 or ISO 9001 certificate means: an independent certification body audited the organization's QMS against the standard for a stated scope and sites.

  • ISO itself does not certify organizations; certification bodies do.
  • ISO 13485 is a QMS standard; an ISO 13485 certificate is not a product approval, CE marking or FDA clearance.
  • Some regulators require or rely on QMS certification (e.g. Health Canada requires an MDSAP-issued ISO 13485 certificate for Class II-IV licence applications), which is a regulatory use of a voluntary standard.
  • Check that the certification body is accredited for that scope and that the certificate can be verified with the issuer.
  • QMS certification is different from FDA inspection: FDA does not issue ISO 13485 certificates.

Conformity assessment

Conformity assessment is any process showing that specified requirements are met: testing, inspection, certification, or a manufacturer's own declaration.

Gives the umbrella term for how products, processes, systems or organizations are shown to meet requirements, and explains its legal meaning in the EU medical device framework.

  • CE marking signals that the manufacturer claims conformity with all applicable EU requirements following the required conformity assessment; it is not a quality mark or a product certification by the EU.
  • A notified body certificate under the MDR is part of conformity assessment, not an EU 'approval' issued by the European Commission.
  • Using a harmonised standard gives a presumption of conformity only for the requirements that standard covers.

Accreditation of certification, inspection and testing bodies

Accreditation is a formal check of a certification body or laboratory's competence; it is not a certification of the device maker.

Explains the layer above certification: accreditation bodies assess whether certification bodies, labs and inspection bodies are competent and impartial.

  • Manufacturers are certified, not accredited; a company claiming to be 'ISO 13485 accredited' is usually misusing the term.
  • Regulatory designation is separate from accreditation: EU notified bodies are designated by member-state authorities under the MDR/IVDR, and MDSAP auditing organizations are recognized by the participating regulators.
  • FDA's ASCA programme uses accredited testing laboratories for certain recognized standards; it is a voluntary FDA programme in which testing laboratories accredited to ISO/IEC 17025 plus ASCA specifications perform testing for premarket submissions; it does not replace premarket review.
  • Unaccredited certificates may not be accepted by buyers or regulators.

Product safety and performance standards

Safety and performance standards define technical methods and requirements for products; they are voluntary unless a law or regulator makes them mandatory or recognises them.

Explains how technical standards (e.g. IEC 60601 series, ISO 10993 series, ISO 11135/11137) relate to regulation: they are tools to show requirements are met, not laws themselves.

  • In the EU, applying harmonised standards is voluntary but gives a presumption of conformity with the requirements they cover.
  • FDA recognition can be complete or partial; a declaration of conformity to a recognized standard can support, but does not replace, a premarket submission.
  • Standards have editions and transition periods; an outdated edition may no longer be accepted.
  • Not every standard applies to every device: e.g. IEC 60601-1 applies to medical electrical equipment, not to a manual stainless-steel forceps.

Market-specific labelling and documentation

Each market sets its own rules for labels, instructions for use, languages, identifiers and local contact details; international standards help but do not override them.

Explains why the same device may need different labels and documents in different markets, and how labelling standards fit in.

  • ISO 15223-1 symbols and ISO 20417 content requirements are voluntary standards; the law of each market decides what is mandatory.
  • EU MDR Annex I Chapter III sets EU labelling and IFU requirements; FDA labelling rules are in 21 CFR (e.g. Part 801).
  • A symbol accepted in one market may need accompanying text in another.

Medical device classification

Every market classifies devices by risk, but the systems differ: US Class I/II/III, EU Class I/IIa/IIb/III and India’s Class A–D are not equivalent. Classification follows the intended purpose and each jurisdiction’s rules, not the manufacturer’s product description alone.

Risk-based device classification

Devices are grouped into risk classes that drive the authorization route; each country has its own rules and the class systems are not interchangeable.

Explains that regulators sort devices from lower to higher risk, and that the class determines how much evidence and third-party involvement is needed.

  • US uses Class I, II, III; the EU MDR uses Class I, IIa, IIb, III (with sub-categories such as sterile, measuring and reusable surgical instruments in Class I); India's Medical Devices Rules 2017 use Classes A, B, C, D. These do not map one-to-one.
  • Classification depends on intended purpose, duration of contact, invasiveness, body site, energy source and other factors defined in each jurisdiction's rules.
  • A manufacturer's marketing description or a supplier's catalogue label does not decide the class; the applicable rules applied to the intended purpose do.
  • The same instrument can fall into different classes in different markets, and a change in intended use can change the class.
  • IVD classification is separate in many systems (e.g. EU IVDR Classes A-D).

Related FAQs

All certification and regulatory FAQs

This directory is provided for general informational and educational purposes only. Medical device regulatory requirements vary according to product classification, intended use, manufacturer or importer activities, and destination market. Requirements may change over time. This information is not legal or regulatory advice and does not guarantee market authorization. Manufacturers should verify the applicable requirements with the relevant regulatory authority and qualified regulatory professionals.

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