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- Component substitution: when does a swap need retest?
Component substitution: when does a swap need retest?
The semiconductor shortage that began in 2020 made component substitution routine in electronics design offices, and end-of-life notices keep it that way. Replacing a MOSFET, a radio module or a ceramic capacitor looks trivial, yet each swap reopens the question of whether the product still matches its assessment. The texts answer in different ways: the EU directives give a duty to keep series production in conformity and a living technical file, 47 CFR 2.1043 gives three permissive change classes, PTCRB gives an Engineering Change Order, the MDR asks for notified body approval. This guide reads each text as published on 7 October 2026, sets out what a swap triggers under each, and lists the readings the texts contradict, including some that earlier versions of this page made.
Two questions, two rules
Section titled “Two questions, two rules”A component swap raises one of two questions, and the EU texts answer them with different rules.
- The swap is made in series production. The units built after the change have not yet been placed on the market. Each New Legislative Framework directive says the same thing in its manufacturer article: "Manufacturers shall ensure that procedures are in place for series production to remain in conformity", and changes in product design or characteristics, and in the harmonised standards, "shall be adequately taken into account". The texts do not list which changes need new tests. The manufacturer decides, against the essential requirements the part can affect, and the evidence goes into the technical documentation.
- The swap is a repair on a unit already on the market. The Blue Guide 2022 (section 2.1) says repaired products that are not considered new do not need to undergo conformity assessment again. Replacing a defective or worn item by a spare part "either identical, or at least similar, to the original part" is repair, even if the new part performs better, as long as the product stays within "the intended use, range of performance and maintenance originally conceived at the design stage".
The technical documentation of the LVD, the EMC Directive and the RED must include the "conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits". A changed bill of materials is a change to that documentation, whether or not new tests are needed. The EU declaration of conformity is kept up to date with it. For the general CE route, see the CE procedure guide. For RED specifics, see RED procedure.
The texts article by article
Section titled “The texts article by article”| Text | Series production rule | Change to a type-examined design | Record keeping |
|---|---|---|---|
| LVD 2014/35/EU | Article 6(4) | No notified body module in the LVD (internal production control, Annex III) | Article 6(3): 10 years after placing on the market |
| EMC 2014/30/EU | Article 7(4) | Annex III point 7: inform the notified body of all modifications that may affect conformity; addition to the EU-type examination certificate | Article 7(3): 10 years |
| RED 2014/53/EU | Article 10(5) | Annex III point 7, same wording | Article 10(4): 10 years |
| ATEX 2014/34/EU | Article 6(4) | Annex III point 7, same wording | Article 6(3): 10 years |
| MDR 2017/745 | Article 10(9), same wording, with common specifications added | Annex IX section 4.10, Annex X section 5.2: notified body approval of changes that could affect safety and performance | Article 10(8): at least 10 years after the last device, 15 for implantable devices |
| 47 CFR (FCC) | Section 2.932: a new application whenever design, circuitry or construction changes, except permissive changes | Section 2.1043: Class I, II, III, or a new grant | Section 2.938 |
Radio equipment is not assessed under the LVD and the EMC Directive in parallel. RED Article 3(1)(a) covers health and safety "with no voltage limit applying", and Article 3(1)(b) covers EMC. The EMC Directive excludes equipment covered by Directive 1999/5/EC (Article 2(2)(a)), a reference that RED Article 50 redirects to the RED.
LVD: the critical components come from the standard
Section titled “LVD: the critical components come from the standard”The LVD covers electrical equipment designed for use between 50 and 1000 V AC or between 75 and 1500 V DC (Article 1). It contains no list of safety-critical components. That list comes from the harmonised standard applied and from the test report written against it.
- IEC 62368-1 (audio, video, IT and communication equipment) sets component requirements in Annex G. The safeguards identified in the report rely on specific components, and the report records them. The edition cited under the LVD on 7 October 2026 is EN 62368-1:2014 + AC:2015.
- IEC 60335-1 (household appliances): the cited edition is EN 60335-1:2012 up to A15:2021, with a restriction on clause 20.2 (Decision (EU) 2025/1457). EN IEC 60335-1:2023 is not cited.
- IEC 60601-1 (medical electrical equipment, under the MDR rather than the LVD) separates means of operator protection (MOOP) and means of patient protection (MOPP) in clause 8, with their own test voltages, creepage distances and air clearances.
The parts that typically carry a safeguard in these standards are isolating transformers, optocouplers and capacitors (class X and Y) that bridge an insulation barrier, fuses and other protective devices, and limited power sources (IEC 62368-1 Annex Q). Swapping one of them means showing that the new reference meets the same component requirements: by its own certificate against the component standard the report relies on, or by the tests the standard specifies. The presumption of conformity attached to the original report does not move to a different part automatically. Parts with no role in a safeguard (a pull-up resistor, a low-voltage logic gate) normally only need the BOM and the documentation updated, with the reasoning recorded. See the IEC 62368-1 guide and the IEC 60601-1 guide.
EMC: the whole apparatus is the test object
Section titled “EMC: the whole apparatus is the test object”EMC conformity is assessed on the apparatus as a whole, against emission and immunity standards such as EN 55032 (CISPR 32), EN 55035, EN 55014-1 and -2, or the generic EN 61000-6 series. No standard qualifies a decoupling capacitor or a ferrite for EMC on its own, so a substitution is judged by its plausible effect on the measured results and on the margins recorded in the original report.
Where engineering experience points:
- Clock sources and switching regulators set much of the emission spectrum: switching frequency, spread-spectrum modulation and edge rates all matter. A different part here is the swap most likely to move radiated and conducted emissions.
- Filtering parts (ferrites, common-mode chokes, X and Y capacitors in a mains filter) are compared on impedance over frequency, not on nominal value. MLCC capacitance also falls with DC bias, and the drop differs between manufacturers.
- Interface protection parts (TVS diodes, series resistors and filters on connectors) set immunity to electrostatic discharge (ESD), fast transients and surges; a different clamping characteristic can change the immunity result.
- Same-value, same-technology passives away from fast edges and interfaces are usually a documentation update.
When the original report showed little margin, a pre-compliance scan of the changed product is the cheapest way to decide between a documentation update and a new test. Cost ranges for test campaigns are in the certification cost guide. The EMC Directive treats "components" or "sub-assemblies" intended for incorporation into an apparatus by the end user, and liable to generate or be affected by disturbance, as apparatus in their own right (Article 3(2)).
RED: the radio module question
Section titled “RED: the radio module question”Swapping a radio module
Section titled “Swapping a radio module”The RED does not define an "equivalent" module. Three passages of the July 2026 RED Guide decide the question:
- Section 1.7.4.11: RF modules, and integrated circuits able to transmit or receive once integrated, are radio equipment. Their maker assesses the risks identifiable before integration and gives instructions that keep them compliant, "without prejudice to any new obligations that might arise when the above components (radio equipment) are integrated into another product".
- Section 1.7.4.1: when radio equipment is incorporated and permanently fixed in a non-radio electrical product, the RED applies to the combination as a whole, which is a single product.
- Article 17(1), as read by the Guide: the manufacturer takes into account all intended operating conditions, and the assessment confirms conformity in every possible configuration.
The manufacturer of the final product therefore owns the assessment. A replacement module with a different chipset, a different antenna or firmware that changes power or channel access needs a new assessment of Article 3(2) (efficient use of spectrum: EN 300 328 at 2.4 GHz, EN 301 893 for 5 GHz RLAN, EN 300 220 for short range devices from 25 MHz to 1000 MHz, EN 301 908 series for IMT cellular), of Article 3(1)(b) EMC (EN 301 489 series) and of Article 3(1)(a) safety and RF exposure in the host. A module reissued by its maker under the same type, with the same radio parameters and the same antenna rules, is mostly a documentation check: compare the new module documentation with what the host assessment relied on.
Where the product went through EU-type examination (module B), Annex III point 7 requires the manufacturer to inform the notified body of all modifications to the approved type that may affect conformity; those need "an addition to the original EU-type examination certificate". Since 1 August 2025 Article 3(3)(d), (e) and (f) also apply to internet-connected radio equipment, with EN 18031-1, -2 and -3 cited with restrictions (Decision (EU) 2025/138): a module whose firmware brings a different security behaviour reopens that assessment too.
Passive and active RF parts
Section titled “Passive and active RF parts”RF filters, baluns and matching parts set out-of-band and spurious emissions; power amplifiers, low noise amplifiers and oscillators set power, frequency accuracy and receiver behaviour. A change in these parts affects Article 3(2) parameters directly, and the corresponding clauses of the applied harmonised standard need re-measuring unless the evidence shows the parameter cannot move. See the RED checklist.
FCC: 47 CFR 2.1043, read correctly
Section titled “FCC: 47 CFR 2.1043, read correctly”Section 2.1043 of 47 CFR applies to certificated equipment. Its paragraph (a) comes first in any screening, because it sends some changes outside the permissive classes altogether.
| 47 CFR 2.1043 | Scope | Filing |
|---|---|---|
| (a) | Changes to the basic frequency determining and stabilizing circuitry (including clock or data rates), frequency multiplication stages, basic modulator circuit, or maximum power or field strength ratings | New grant of certification, except a Class III change |
| (a), last sentence | Software changes that do not affect RF emissions | None; may be made by parties other than the grantee |
| (b)(1) Class I | Modifications that do not degrade the characteristics reported and accepted at certification | None |
| (b)(2) Class II | Modifications that degrade the reported performance characteristics; the degraded performance must still meet the minimum requirements of the rules | Test results for the characteristics affected, plus the Covered List certifications; no marketing under the grant before acknowledgement |
| (b)(3) Class III | Software changes to a software defined radio that change frequency range, modulation type or maximum output power outside the approved parameters, or the circumstances of operation | Description and test results with the new software, including RF exposure; only if no Class II change has been made |
| (b) | None of the three classes may result in a change in identification | A new FCC ID needs a new application (2.1043(d), 2.933) |
| (b)(4) | Class I and Class II changes may only be made by the holder of the grant, except as specified |
Applied to substitutions: a new crystal or oscillator on the radio is a 2.1043(a) item and needs a new grant. A filter or matching part that leaves every reported result unchanged or better is Class I, with the evidence kept on file (2.938 requires a record of changes that may affect compliance). A part that degrades a reported emission while staying within the limits is Class II. The FCC interprets the section in KDB 178919 (D01 Permissive Change Policy v06), grouped by antenna, PCB and hardware, enclosure, software and RF exposure changes. For the full paragraph-by-paragraph reading, see FCC permissive changes.
Modules. A host that uses a certified modular transmitter relies on the module grant under 47 CFR 15.212; the module carries its own FCC ID, and the host is labelled "Contains FCC ID: ..." or with equivalent wording. Replacing it with the same module (same FCC ID) is used within that grant and its conditions. A module with a different FCC ID brings different grant conditions (KDB 996369 explains limited modules and host-specific Class II filings) and the host still has to meet its own Part 15 Subpart B obligations as an unintentional radiator. KDB 353028 adds that only the module grantee can request a permissive change: if the grantee will not file a Class II change to add an antenna, a new application under a different FCC ID is needed.
Covered List. From 13 October 2026, the Third Report and Order (91 FR 57798) requires a new grant for any change made by an entity on the Covered List, and permissive change procedures are no longer available for equipment produced by such an entity. Check the supplier of a substituted radio module against the Covered List before treating the swap as a permissive change.
PTCRB: an Engineering Change Order, not a "delta"
Section titled “PTCRB: an Engineering Change Order, not a "delta"”PTCRB is an industry certification program for cellular devices, administered by CTIA Certification; the name originally stood for PCS Type Certification Review Board. It is not part of 47 CFR. Under the Program Management Document (PPMD V4.2, October 2026), an ECO (Engineering Change Order) certification request is required for (section 11.6.1):
- any change to the hardware or hardware version;
- any change of the radio or protocol stack that changes the software version or SVN;
- any recompilation of the radio or protocol stack.
The Primary Test Laboratory decides whether full or partial retesting is needed (11.6.4). Software loaded over the air must bit-match certified software, otherwise it must itself be certified (11.3.2). Operators that rely on PTCRB may run their own acceptance programs on top. See the PTCRB pillar, the PTCRB procedure and the 3GPP RF conformance test plan guide.
MDR: approval of changes, and the legacy test
Section titled “MDR: approval of changes, and the legacy test”For a device certified under the MDR, Annex IX section 4.10 requires approval from the notified body that issued the EU technical documentation assessment certificate for changes to the approved device that could affect safety and performance or the conditions prescribed for use; the manufacturer informs the notified body of the planned change, and the notified body decides whether a new conformity assessment is needed. Annex X section 5.2 has the equivalent for EU-type examination. A swap of a sensor, an applied part or a patient-contacting material is a typical candidate.
The "significant change" test is Article 120: a legacy device certified under Directive 90/385/EEC or 93/42/EEC can stay on the market under the transitional provisions only without significant changes in design or intended purpose. MDCG 2020-3 Rev. 1 explains that test; it does not apply to devices already certified under the MDR. See MDR Class IIb and III and substantial modification and recertification in the EU.
ATEX: the certificate follows the type
Section titled “ATEX: the certificate follows the type”Under Directive 2014/34/EU, equipment of categories M1 and 1, and electrical equipment and internal combustion engines of categories M2 and 2, go through EU-type examination (Article 13(1)(a) and (b)(i)); other category M2 and 2 equipment and category 3 equipment use internal production control. Annex III point 7 then requires the manufacturer to inform the notified body of all modifications to the approved type that may affect conformity with the essential health and safety requirements or the conditions of validity of the certificate; such modifications need an addition to the certificate. In intrinsic safety (Ex i, EN 60079-11:2012 cited), the parts that limit energy in the circuit are part of the assessed design, so a change to one of them is exactly the kind of modification the notified body must hear about. For flameproof enclosures (Ex d), the enclosure, its joints and its entries carry the protection. See the ATEX guide.
Automotive: AEC-Q requalification and change notices
Section titled “Automotive: AEC-Q requalification and change notices”AEC-Q100 Rev-J1 (24 March 2026), section 3.2, requires requalification of a device when the supplier makes a product or process change that impacts, or could potentially impact, form, fit, function, quality or reliability. Table 3, "Process Change Qualification Guidelines for the Selection of Tests", maps each type of change to the stress tests to consider. Section 3.2.1 says the supplier "will meet the user requirements" for change notification, and section 3.4 leaves user approval to IATF 16949, customer specific requirements or AIAG PPAP. See the AEC-Q100, Q101 and Q200 guide.
Outside automotive, the common reference is J-STD-046, the joint JEDEC, ECIA and IPC standard that replaced JESD46 in 2016. Supplier policies that cite it commit to notify major changes (those that may affect form, fit, function, quality or reliability) at least 90 days before the change, and treat the change as accepted if the customer does not acknowledge within 30 days. The standard text is sold, not public; these figures are taken from supplier policies.
Spare parts and production
Section titled “Spare parts and production”| Situation | Rule | Source |
|---|---|---|
| Repair with an identical part | No new conformity assessment | Blue Guide 2.1 |
| Repair with a similar part (technical progress, discontinued original), product within its original design envelope | No new conformity assessment | Blue Guide 2.1 |
| Repair or update that modifies functions, radio interface, type or performance not foreseen in the risk assessment, with a changed hazard or higher risk, then made available | New product | Blue Guide 2.1; RED Guide 1.5 |
| Swap in series production | Series conformity duty; documentation updated | LVD 6(4), EMC 7(4), RED 10(5), ATEX 6(4) |
| Component or sub-assembly sold to end users for incorporation | Can be apparatus in its own right | EMC Article 3(2); Blue Guide 2.1 |
The Blue Guide adds that, within the terms of a specific act, components, spare parts or sub-assemblies may be regarded as finished products, and must then comply when first supplied on the Union market. A replacement radio module, power supply or board sold separately is the usual case.
Screening matrix
Section titled “Screening matrix”The matrix is an engineering screening aid, not a rule from any text: it says where to look first. Each "re-measure" means the clauses of the applied standard that the part can influence.
| Part changed | LVD or RED 3(1)(a) | EMC or RED 3(1)(b) | RED 3(2) | FCC 47 CFR 2.1043 |
|---|---|---|---|---|
| Passive, no safeguard, away from fast edges | Documentation | Documentation | Documentation if outside the RF path | Class I if nothing reported degrades |
| Part named in the safety report (transformer, Y capacitor, fuse, optocoupler) | Component evidence or test | Check if part of the mains filter | Not usually | Class I or II per reported results |
| Filter or matching part in the RF path | Not usually | Possible | Re-measure out-of-band and spurious | Class I if no degradation, Class II if degraded within limits |
| Clock source or switching regulator | Temperature and protection checks if on a primary circuit | Re-measure emissions | If it sets the radio reference | 2.1043(a) if it is the frequency determining circuitry of the transmitter |
| RF active (PA, LNA, oscillator) | Not usually | Possible | Re-measure | 2.1043(a) items need a new grant; otherwise Class II |
| Same radio module, same type, same antenna rules | Documentation | Documentation | Documentation | Within the module grant |
| Different radio module | Host assessment | Host assessment | New assessment | Different FCC ID and grant conditions; host Part 15B |
| Antenna | Exposure check | Possible | Re-measure | KDB 353028: Class II for new antenna types |
A substitution workflow that maps to the texts
Section titled “A substitution workflow that maps to the texts”- Record the change. Old and new part number, BOM lines, firmware version, supplier notice if any, effective date.
- Screen against the hard stops. 47 CFR 2.1043(a) items; PTCRB ECO triggers; parts named in the safety report; a type-examined design under Annex III point 7; MDR Annex IX 4.10.
- List the affected requirements. For each market, name the essential requirement or rule section the part can influence.
- Gather the evidence. Component certificate, comparison of datasheet parameters that matter, pre-compliance scan, or formal test of the affected clauses.
- File where a text says so. Class II or Class III filing, new FCC application, PTCRB ECO, notified body notice or approval.
- Hold shipments where a text says so. No marketing under the FCC grant before Class II acknowledgement; no MDR change before approval.
- Update and close. Technical documentation, EU declaration of conformity if its content changes, production cut-over by serial number, archive for 10 years.
What changed from 2023 to 2026
Section titled “What changed from 2023 to 2026”| Date | Text | Effect on substitutions |
|---|---|---|
| 6 February 2023 | FCC Covered List equipment authorization rules (88 FR 7624) | Permissive changes unavailable for prohibited equipment; Class II and III filings carry Covered List certifications |
| 1 August 2025 | RED Article 3(3)(d), (e), (f) apply; EN 18031 series cited with restrictions (Decision (EU) 2025/138) | A module or firmware swap can affect the cybersecurity assessment |
| 24 March 2026 | AEC-Q100 Rev-J1 | Current requalification rules and Table 3 for IC changes |
| 7 July 2026 | RED Guide, July 2026 version | Sections 1.5, 1.7.4.1 and 1.7.4.11 on updates, combined equipment and RF modules |
| 11 September 2026 | Cyber Resilience Act Article 14 reporting obligations apply (full application 11 December 2027) | Actively exploited vulnerabilities and severe incidents must be reported, also for products already on the market |
| October 2026 | PTCRB PPMD V4.2 | ECO triggers in section 11.6 |
| 13 October 2026 | FCC Third Report and Order (91 FR 57798) | New grant for any change made by a Covered List entity |
Claims the texts contradict
Section titled “Claims the texts contradict”| Common claim (including earlier versions of this page) | What the text says |
|---|---|
| "FCC Class III is a change of modulation or an added band, with a new certificate and a new FCC ID" | Class III covers software changes to a software defined radio only, and no permissive change may change the FCC ID (2.1043(b), (b)(3)). |
| "FCC Class II is an amendment filing for any change that does not touch modulation or band" | Class II covers changes that degrade reported characteristics while still meeting the rules (2.1043(b)(2)); changes to frequency determining circuitry, clock or data rates, the modulator or the rated power need a new grant (2.1043(a)). |
| "The FCC accepts delta tests with a signed memo from the responsible engineer" | 2.1043(b)(2) requires complete information and test results for the characteristics affected, with the Covered List certifications. No memo route is in the rule. |
| "KDB 178919 is at id 44637" | id 44637 is KDB 996369 (modules); KDB 178919 is id 33013. |
| "PTCRB stands for Permanent Trade Mark Initiative for Cellular Radio Board" | The name originally stood for PCS Type Certification Review Board. Changes go through an ECO request (PPMD 11.6.1), not a "PTCRB Delta". |
| "A different radio module needs a new EN 301 489 campaign for Article 3.2" | EN 301 489 is the EMC series under Article 3(1)(b). Article 3(2) is assessed with the radio standards (EN 300 328, EN 301 893, EN 300 220, EN 301 908). |
| "A module swap is transparent if it falls under the same EU-type examination certificate" | Most modules are not type-examined. The RED applies to the combination in the host and the host maker assesses it (RED Guide 1.7.4.1 and 1.7.4.11). |
| "The RED adds requirements on top of the LVD and the EMC Directive" | Radio equipment covers safety and EMC through RED Article 3(1)(a) and (b); the EMC Directive excludes it. |
| "Under the MDR, a substitution is a significant change under Article 120, with tacit notification to the notified body" | Article 120 is the legacy device test. MDR-certified devices follow Annex IX 4.10 or Annex X 5.2: inform the notified body, which approves. |
| "The Blue Guide says spare parts installed by maintenance are not subject to the directives" | It says repaired products do not need a new conformity assessment, and that components or spare parts may themselves be finished products under a specific act. |
| "An impedance variation above 30% shifts the emission profile" | No standard sets such a threshold. The decision rests on the measured margins of the product. |
| "Automotive change notices come with a six to twelve month lead time" | AEC-Q100 leaves notification to user requirements (3.2.1). Supplier policies citing J-STD-046 give at least 90 days. |
| "Every change needs a new DoC with an incremented number" | The directives require the declaration and documentation to be kept up to date; the numbering scheme is the manufacturer choice. |
Common pitfalls
Section titled “Common pitfalls”| Pitfall | Consequence | Prevention |
|---|---|---|
| Reading "drop-in replacement" in a datasheet as regulatory equivalence | Swap made without the evidence the texts expect | Compare the parameters the applied standard relies on |
| Supplier notices not tracked against BOM lines | Changed part in production without analysis | Link every notice to the BOM line and to an owner |
| Treating a clock or crystal swap as Class I | Marketing outside the FCC grant | Screen 2.1043(a) first |
| Swapping a cellular module firmware without an ECO | Device no longer matches its PTCRB certification | Lock the radio firmware version in the release gate |
| Checking only the module FCC ID, not the grant conditions | Host outside the limits of a limited module grant | Read the module grant and KDB 996369 |
| Forgetting the notified body under module B | Certificate no longer covers the type | Annex III point 7 check in the change workflow |
The spilma glossary defines the key terms used here.
See also
Section titled “See also”- FCC permissive changes: Class I, II, III and RED delta
- Substantial modification and recertification in the EU
- EU market surveillance and Safety Gate (formerly RAPEX)
- Product recall and EU Safety Gate response procedure
- EU Declaration of Conformity (DoC): template + content
- FCC vs CE EMC
Sources & references
- Directive 2014/35/EU (LVD), Articles 1, 6 and Annex III, EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
- Directive 2014/30/EU (EMC), Articles 2, 3(2), 7(4) and Annexes II and III, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
- Directive 2014/53/EU (RED), Articles 3, 10(5), 17 and Annexes III and V, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
- Directive 2014/34/EU (ATEX), Article 6(4) and Annex III point 7, EUR-Lex eur-lex.europa.eu/eli/dir/2014/34/oj
- Guide to the Radio Equipment Directive 2014/53/EU (July 2026 version), sections 1.5, 1.7.4.1 and 1.7.4.11, European Commission single-market-economy.ec.europa.eu/document/download/a0c7e4c5-27db-4c59-9c43-a380ed21563f_en?filename=RED%20Guide%20-%20version%2007.07.2026%20-%20with%20COVER.pdf
- Blue Guide on the implementation of EU product rules 2022, section 2.1, European Commission eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
- Regulation (EU) 2017/745 (MDR), Article 120 and Annexes IX and X, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
- 47 CFR 2.1043, changes in certificated equipment, Electronic Code of Federal Regulations www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/section-2.1043
- 47 CFR 2.938, retention of records, Electronic Code of Federal Regulations www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/section-2.938
- 47 CFR 15.212, modular transmitters, Electronic Code of Federal Regulations www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-A/section-15.212
- FCC KDB 178919, Section 2.1043 permissive changes (D01 Permissive Change Policy v06), Federal Communications Commission apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?id=33013&switch=P
- FCC KDB 996369, modules and module certification (Section 15.212), Federal Communications Commission apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?id=44637&switch=P
- FCC KDB 353028, antennas used with Part 15 intentional radiators, Federal Communications Commission apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?id=39060&switch=P
- FCC Third Report and Order, 91 FR 57798 (11 September 2026), effective 13 October 2026, Federal Register www.federalregister.gov/documents/2026/09/11/2026-18535/protecting-against-national-security-threats-to-the-communications-supply-chain-through-the
- PTCRB Program Management Document (PPMD) V4.2, October 2026, section 11.6, PTCRB www.ptcrb.com/wp-content/uploads/2026/10/PTCRB-PPMD-V4.2.pdf
- AEC-Q100 Rev-J1 (24 March 2026), section 3.2 and Table 3, Automotive Electronics Council www.aecouncil.com/files/Documents/AEC%20Q100-Rev%20J1.pdf
- Product change notification policy citing J-STD-046 (secondary source: supplier page, standard text not freely available), SGMICRO www.sg-micro.com/reliability/product-change-notification
- Product change notification, compliance with J-STD-046 (secondary source: supplier page), Texas Instruments www.ti.com/support-quality/quality-policies-procedures/product-change-notification.html
Frequently asked questions
- Does a component substitution automatically trigger a new certification?
- No. For a product still in series production, the EU directives ask the manufacturer to keep production in conformity and to take changes in design or characteristics adequately into account (LVD Article 6(4), EMC Article 7(4), ATEX Article 6(4), RED Article 10(5)). Nothing in those texts lists which swaps need new tests: the manufacturer decides, on the basis of the essential requirements the part can affect, and records the decision in the technical documentation, which includes the drawings and schemes of components and circuits. Where an EU-type examination certificate exists, Annex III point 7 of each of those directives adds a duty to inform the notified body. In the US, 47 CFR 2.1043 sorts changes to certificated equipment into three permissive classes and a new grant.
- Which components does the LVD treat as safety critical?
- The LVD itself has no list of critical components. The list comes from the harmonised standard applied: IEC 62368-1 sets requirements for components in Annex G, and the test report records the components on which the safeguards rely. Isolating transformers, optocouplers bridging a safeguard, class X and Y capacitors, fuses and protective devices usually appear there. The cited editions on 7 October 2026 are EN 62368-1:2014 + AC:2015 and EN 60335-1:2012 up to A15:2021 (restricted on clause 20.2 by Decision (EU) 2025/1457). Swapping a listed component for another reference means showing that the new one meets the same component requirements, which the standard checks by certificate or by test.
- Can a radio module be replaced by an equivalent without new RED tests?
- The RED does not say "equivalent". When the module is incorporated and permanently fixed in the product, the RED applies to the combination as a whole (RED Guide, section 1.7.4.1), and the manufacturer of the final product must assess conformity under all intended operating conditions (Article 17(1)). The module maker assessment and instructions are made "without prejudice to any new obligations" arising on integration (section 1.7.4.11). A new module with a different chipset, antenna or firmware therefore needs a new assessment of Article 3(2) radio parameters and of 3(1)(a) and 3(1)(b) safety, exposure and EMC in the host. EN 301 489 is the EMC series under 3(1)(b), not a spectrum test.
- What are FCC Class I, Class II and Class III permissive changes?
- 47 CFR 2.1043(b). Class I: changes that do not degrade the characteristics reported at certification; no filing. Class II: changes that degrade the reported characteristics while still meeting the rules; the grantee files test results for the characteristics affected and may not market under the grant before acknowledgement. Class III: software changes to a software defined radio that move frequency range, modulation type or maximum output power outside the approved parameters. None of the three may change the FCC ID. Changes to frequency determining circuitry (including clock or data rates), multiplication stages, the modulator or the maximum power rating need a new grant (2.1043(a)).
- Does a supplier PCN force a retest?
- No text says so. A product or process change notice is the supplier telling you something changed; the regulatory question is still whether your product keeps meeting the requirements that the part affects. Many semiconductor suppliers state that they follow J-STD-046 (the joint JEDEC, ECIA and IPC standard that replaced JESD46 in 2016), and publish a minimum notice of 90 days before the changed product ships. For automotive parts, AEC-Q100 Rev-J1 (24 March 2026) requires requalification when a change could impact form, fit, function, quality or reliability, and leaves user approval to IATF 16949, customer specific requirements or AIAG PPAP.
- Spare parts versus production: what is the difference?
- Two different rules apply. A repair on a unit already on the market, with a spare part identical or at least similar to the original, does not need a new conformity assessment, even if the part performs better, as long as the product stays within the use, performance and maintenance conceived at the design stage (Blue Guide 2022, section 2.1). A swap in series production changes the units still to be placed on the market, so it falls under the series conformity duty and the technical documentation must be updated. A spare part sold on its own may itself be a product: the EMC Directive treats components and sub-assemblies intended for incorporation by the end user as apparatus (Article 3(2)).
- What does the MDR require when a component of a certified device changes?
- For devices certified under the MDR, Annex IX section 4.10 requires the manufacturer to inform the notified body of planned changes that could affect safety and performance or the conditions prescribed for use, and the notified body approves them; Annex X section 5.2 has the equivalent rule under EU-type examination. The "significant change" test is a different rule: it belongs to Article 120 and decides whether a legacy device certified under the old directives can stay on the market under the transitional provisions.
- What must the change records show?
- The EU directives require the technical documentation and the EU declaration of conformity to be kept for 10 years after the product has been placed on the market, and the documentation to include the drawings and schemes of components, sub-assemblies and circuits. A substitution file should therefore show the old and new part, the requirements it can affect, the evidence (certificate, test or reasoning) and the production cut-over. For FCC certified equipment, 47 CFR 2.938 requires a record of changes that may affect compliance, kept for one year after marketing of the equipment has been permanently discontinued.