EU Market Surveillance Regulation vs Decision No 768/2008/EC side-by-side comparison
Regulation (EU) 2019/1020 is the enforcement and market-surveillance layer for covered Union harmonisation products: Article 4 responsible economic operators, distance sales, cooperation, corrective action, customs controls, ICSMS, and EU Product Compliance Network coordination.
Decision No 768/2008/EC is the common product-marketing framework that sector laws can draw from for economic-operator obligations, conformity-assessment modules, notified bodies, CE marking, and declaration-of-conformity structure.
Use the applicable sector act, not by itself, to determine a product's conformity duties and assessment module. Decision 768 supplies model provisions for sector legislation. Use Regulation (EU) 2019/1020 separately for surveillance, where applicable, targeted online offers, authority cooperation, corrective action, and controls on products entering the Union market.
Side-by-side comparison
EU Market Surveillance Regulation vs Decision No 768/2008/EC: side-by-side comparison
A cited-source comparison of Regulation (EU) 2019/1020 and for separating market surveillance, customs, , CE marking, , and sector-law implementation work.
The MSR side governs market surveillance and enforcement for covered Union harmonisation products: responsible economic operators, online offers, cooperation with authorities, corrective action, customs controls, ICSMS, and EU Product Compliance Network coordination.
Second framework
Decision No 768/2008/EC
The Decision 768 side is the common product-marketing framework that sector legislation can use or adapt for definitions, economic-operator obligations, , notified bodies, CE marking, declarations of conformity, and safeguard procedures.
EU Market Surveillance Regulation vs Decision No 768/2008/EC: side-by-side comparison
MSR is an operational enforcement framework for products subject to , unless a more specific Union harmonisation provision regulates the same market-surveillance or enforcement aspect.
Decision 768 is a horizontal reference text for future and revised sector legislation; it supplies model provisions rather than replacing the sector law that makes them binding.
Start with the sector act, then use Decision 768 to understand the model conformity structure and MSR to plan surveillance, authority, customs, and work.
MSR defines economic operator broadly, including manufacturer, authorised representative, importer, distributor, fulfilment service provider, and other persons with product obligations; requires a Union-established responsible operator for listed product laws.
Decision 768 provides model obligations for manufacturers, authorised representatives, importers, and distributors, including importer conformity checks, distributor due care, corrective action, and economic-operator traceability.
Assign both roles explicitly: the Decision-derived sector-law operator responsible for conformity and the MSR operator responsible for documentation availability, authority communication, risk notification, and corrective-action cooperation.
MSR is not a conformity-assessment module. It requires a Union-established operator for certain products and assigns tasks around declaration or performance records, technical documentation availability, authority requests, product-risk information, and corrective action.
Decision 768 contains and related notified-body patterns that sector laws may select, such as internal production control, EU-type examination, production quality assurance, product verification, unit verification, and full quality assurance.
Use to confirm who can answer authorities; use the sector law and its Decision 768-style module to decide what tests, certificates, quality-system records, declarations, and notified-body actions are needed before placement.
MSR can require the operator to verify that required declarations and technical documentation have been drawn up and can be made available to authorities; it is not the general source of CE marking design or declaration model rules.
Decision 768 provides model provisions for declaration-of-conformity structure, manufacturer responsibility for compliance, CE marking principles, visible and indelible affixing, and notified-body identification where required.
Keep CE marking and EU declaration decisions in the sector-law conformity file, then link that file to the MSR evidence showing the responsible operator can provide it when authorities ask.
MSR evidence should show role selection, name and contact placement, technical-documentation availability, authority-request responses, risk notifications, corrective actions, border-control events, and ICSMS/Safety Gate references where applicable.
Decision 768-derived evidence should show the selected conformity module, technical documentation, declaration of conformity, CE marking decision, notified-body certificates or quality-system approvals, importer checks, distributor due care, and operator traceability.
Use one evidence index with tags for MSR, sector-law/Decision-derived conformity, and shared records; do not cite a CE declaration as proof that MSR customs, online, or obligations were handled.
MSR expressly addresses products offered online or through distance sales when targeted at Union end users, and it sets controls for products entering the Union market, including suspension or refusal of release for free circulation and customs information flows to ICSMS.
Decision 768 is not the MSR customs-control framework; its model provisions focus on product marketing obligations, conformity assessment, marking, notified bodies, and market-risk procedures that sector laws can use.
For ecommerce and imports, pair the Decision-derived conformity pack with an MSR release-for-free-circulation and online-offer review, especially where a fulfilment service provider is the only Union-established operator.
MSR establishes the cooperation layer for market surveillance, including single liaison offices, ADCOs, the EU Product Compliance Network, ICSMS, customs interfaces, joint activities, and market-surveillance campaigns.
Decision 768 supplies model procedures for notified bodies, notifying authorities, safeguard procedures, and products presenting a risk, but the actual authority route depends on the sector legislation adopting those provisions.
Authority playbooks should separate conformity-body interactions from market-surveillance interactions: notified-body audits and certificates are not the same workflow as MSR authority requests, ICSMS records, customs holds, or corrective-action cooperation.
MSR applies across listed for surveillance and enforcement. applies to the product laws listed in Article 4(5) and can also apply where another product act expressly makes Article 4 relevant; more specific sector provisions can control a particular surveillance aspect.
Decision 768 expects sector legislation to select, adapt, or justify departure from its common principles and reference provisions, including possible sector-specific adaptations for areas with comprehensive or specialised regimes.
Never stop at the labels MSR or Decision 768. Read the sector act for the product, identify which Decision 768-style provisions it adopts, then overlay MSR only for the surveillance, , online, customs, and cooperation duties that apply.
MSR is an operational enforcement framework for products subject to , unless a more specific Union harmonisation provision regulates the same market-surveillance or enforcement aspect.
Decision 768 is a horizontal reference text for future and revised sector legislation; it supplies model provisions rather than replacing the sector law that makes them binding.
Start with the sector act, then use Decision 768 to understand the model conformity structure and MSR to plan surveillance, authority, customs, and work.
MSR is an operational enforcement framework for products subject to , unless a more specific Union harmonisation provision regulates the same market-surveillance or enforcement aspect.
Decision 768 is a horizontal reference text for future and revised sector legislation; it supplies model provisions rather than replacing the sector law that makes them binding.
Start with the sector act, then use Decision 768 to understand the model conformity structure and MSR to plan surveillance, authority, customs, and work.
MSR defines economic operator broadly, including manufacturer, authorised representative, importer, distributor, fulfilment service provider, and other persons with product obligations; requires a Union-established responsible operator for listed product laws.
Decision 768 provides model obligations for manufacturers, authorised representatives, importers, and distributors, including importer conformity checks, distributor due care, corrective action, and economic-operator traceability.
Assign both roles explicitly: the Decision-derived sector-law operator responsible for conformity and the MSR operator responsible for documentation availability, authority communication, risk notification, and corrective-action cooperation.
MSR is not a conformity-assessment module. It requires a Union-established operator for certain products and assigns tasks around declaration or performance records, technical documentation availability, authority requests, product-risk information, and corrective action.
Decision 768 contains and related notified-body patterns that sector laws may select, such as internal production control, EU-type examination, production quality assurance, product verification, unit verification, and full quality assurance.
Use to confirm who can answer authorities; use the sector law and its Decision 768-style module to decide what tests, certificates, quality-system records, declarations, and notified-body actions are needed before placement.
MSR can require the operator to verify that required declarations and technical documentation have been drawn up and can be made available to authorities; it is not the general source of CE marking design or declaration model rules.
Decision 768 provides model provisions for declaration-of-conformity structure, manufacturer responsibility for compliance, CE marking principles, visible and indelible affixing, and notified-body identification where required.
Keep CE marking and EU declaration decisions in the sector-law conformity file, then link that file to the MSR evidence showing the responsible operator can provide it when authorities ask.
MSR evidence should show role selection, name and contact placement, technical-documentation availability, authority-request responses, risk notifications, corrective actions, border-control events, and ICSMS/Safety Gate references where applicable.
Decision 768-derived evidence should show the selected conformity module, technical documentation, declaration of conformity, CE marking decision, notified-body certificates or quality-system approvals, importer checks, distributor due care, and operator traceability.
Use one evidence index with tags for MSR, sector-law/Decision-derived conformity, and shared records; do not cite a CE declaration as proof that MSR customs, online, or obligations were handled.
MSR expressly addresses products offered online or through distance sales when targeted at Union end users, and it sets controls for products entering the Union market, including suspension or refusal of release for free circulation and customs information flows to ICSMS.
Decision 768 is not the MSR customs-control framework; its model provisions focus on product marketing obligations, conformity assessment, marking, notified bodies, and market-risk procedures that sector laws can use.
For ecommerce and imports, pair the Decision-derived conformity pack with an MSR release-for-free-circulation and online-offer review, especially where a fulfilment service provider is the only Union-established operator.
MSR establishes the cooperation layer for market surveillance, including single liaison offices, ADCOs, the EU Product Compliance Network, ICSMS, customs interfaces, joint activities, and market-surveillance campaigns.
Decision 768 supplies model procedures for notified bodies, notifying authorities, safeguard procedures, and products presenting a risk, but the actual authority route depends on the sector legislation adopting those provisions.
Authority playbooks should separate conformity-body interactions from market-surveillance interactions: notified-body audits and certificates are not the same workflow as MSR authority requests, ICSMS records, customs holds, or corrective-action cooperation.
MSR applies across listed for surveillance and enforcement. applies to the product laws listed in Article 4(5) and can also apply where another product act expressly makes Article 4 relevant; more specific sector provisions can control a particular surveillance aspect.
Decision 768 expects sector legislation to select, adapt, or justify departure from its common principles and reference provisions, including possible sector-specific adaptations for areas with comprehensive or specialised regimes.
Never stop at the labels MSR or Decision 768. Read the sector act for the product, identify which Decision 768-style provisions it adopts, then overlay MSR only for the surveillance, , online, customs, and cooperation duties that apply.
MSR is an operational enforcement framework for products subject to , unless a more specific Union harmonisation provision regulates the same market-surveillance or enforcement aspect.
Decision 768 is a horizontal reference text for future and revised sector legislation; it supplies model provisions rather than replacing the sector law that makes them binding.
Start with the sector act, then use Decision 768 to understand the model conformity structure and MSR to plan surveillance, authority, customs, and work.
How should teams decide what controls the product?
Start with the applicable sector legislation and identify any Decision 768-derived conformity, CE marking, declaration, importer, distributor, notified-body, or safeguard provisions it adopts.
Apply MSR separately for market-surveillance readiness: responsible economic operator, Article 6 online targeting, cooperation with authorities, corrective action, customs release controls, ICSMS records, and network coordination.
Keep the conformity file and the surveillance file linked but distinct so a module certificate, CE mark, or declaration is not mistaken for proof that , customs, or authority-response duties are covered.
Use Regulation (EU) 2019/1020 when the question is market surveillance or enforcement of a product covered by . It defines market-surveillance activity, adds tasks for a Union-established economic operator for listed product laws, treats Union-targeted online offers as market availability, requires cooperation with authorities, and creates controls for products entering the Union market.
Use to understand the model structure behind many sector laws. Article 1 states general principles, Annex I provides reference provisions, and Annex II sets out modules A to H and their variants. The applicable sector act decides which provisions and modules bind the product, may adapt them, and may impose requirements that Decision 768 does not contain.
Do not treat Decision 768 as a directly complete product rule; check the applicable sector act to see which reference provisions, modules, and adaptations it actually uses.
Do not treat MSR as the source of CE marking or module selection; use it for responsible-economic-operator, surveillance, authority cooperation, online, customs, and corrective-action workflows.
For a product launch, record the exact sector-act article and module rather than writing only "Decision 768." Then map the separate MSR duties for market availability, enforcement readiness, and authority interaction.
Evidence split: enforcement file versus conformity file
The MSR evidence set should prove that the right Union-established operator can respond to authorities. Keep the role decision, name and address placement check, declaration and technical-documentation availability check, authority-request process, risk-notification record, corrective-action log, online-offer review, border-hold records, and any ICSMS or Safety Gate references that authorities use.
The Decision 768 evidence set should prove the product-marketing and conformity route selected by the sector act. Keep the selected conformity-assessment module, technical documentation, EU or EC declaration of conformity, CE marking placement decision, notified-body certificate or quality-system record where the module requires it, importer and distributor due-care checks, and traceability of upstream and downstream economic operators.
Tag each record as MSR, Decision 768-derived sector duty, or shared evidence so authority-response material is not confused with conformity-assessment proof.
Keep the technical file and declaration available for the period required by the applicable sector legislation rather than inventing a separate MSR retention period.
Reopen the evidence file when the product, online sales model, importer/distributor role, fulfilment route, harmonised standard, module choice, notified-body status, or authority request changes.
Use the comparison to split conformity and surveillance work
Turn this MSR-versus-Decision-768 comparison into two linked workpacks: one for sector-law conformity, modules, CE marking, and declarations, and one for MSR Article 4, online sales, customs controls, authority cooperation, and corrective action.
Use the comparison to keep two decisions separate: which sector law and Decision 768-derived conformity route controls the product, and which MSR surveillance or customs obligations apply once the product is made available in the Union.
Identify the applicable Union harmonisation act and whether it uses Decision 768-style manufacturer, authorised representative, importer, distributor, CE marking, declaration, module, or notified-body provisions.
Check whether MSR applies to the product category and identify the Union-established manufacturer, importer, authorised representative, or fulfilment service provider responsible for Article 4 tasks.
Confirm whether the sales route includes Union-targeted online or distance sales and whether the offer makes the product available on the Union market under MSR Article 6.
Prepare the Decision 768-derived conformity pack before placement: module record, technical documentation, declaration, marking, instructions, safety information, and required importer or distributor checks.
Prepare the MSR enforcement pack after and around placement: authority-response owner, cooperation process, corrective-action workflow, border-control escalation path, and ICSMS/Safety Gate references where an authority matter arises.
Explains EU product-law concepts including manufacturer responsibility, CE marking, EU declarations of conformity, importers, distributors, notified bodies, and market surveillance.
"The manufacturer is responsible for the conformity assessment of the product"
Sets the common framework and reference provisions for product marketing, economic-operator duties, conformity assessment, CE marking, notified bodies, and products presenting a risk.
"a common framework for the marketing of products"
Defines the MSR market-surveillance framework for covered Union harmonisation products, including economic-operator cooperation, online sales, customs controls, corrective action, and ICSMS.