How to verify a CE mark on imported respiratory devices

Every mid-market and premium oxygen concentrator, CPAP, and BiPAP machine sold in India carries a CE mark somewhere on the cabinet or the box. Indian buyers use CE as a shorthand for “regulated, inspected, safe to buy.” Most of that intuition is correct but some of it is not, and the distinction matters because the CE mark is among the easiest pieces of regulatory labelling to fake. This article covers what CE actually certifies, how to read a CE declaration of conformity, how to verify the Notified Body number on a CE logo against the EU database, what changed with the transition from MDD 93/42 to MDR 2017/745, what UKCA means after Brexit, and the tell-tale signs of a fake CE mark on a grey-market device.

The goal is a 10-minute verification practice that any buyer can perform before handing over ₹35,000–₹2,00,000 for an imported respiratory device. The verification does not require specialist knowledge — the EU’s regulatory databases are public and searchable — but it does require knowing where to look and what the pieces mean.

What CE actually certifies

CE (Conformité Européenne) is a European Union regulatory mark indicating that a product complies with the applicable EU directives or regulations for the product’s category. For medical devices, the applicable regulation is the EU Medical Device Regulation (MDR) 2017/745, which came into force progressively from May 2021, replacing the older Medical Device Directive (MDD) 93/42/EEC for new certifications. The CE mark on a medical device indicates that the manufacturer has demonstrated compliance with the General Safety and Performance Requirements of the MDR (or the Essential Requirements of the older MDD for legacy certifications).

What CE certifies, functionally:

• The manufacturer has a compliant quality management system (typically ISO 13485).
• The device’s technical documentation has been assessed against the regulation’s safety and performance requirements.
• For Class IIa, IIb, and III devices (under the EU classification), a Notified Body — an independent third-party conformity-assessment organisation, designated and monitored by an EU Member State — has assessed the technical file, the QMS, and (for some devices) samples.
• The device’s intended use, indications, contraindications, and warnings have been documented.
• The manufacturer has a post-market surveillance plan and will report incidents through the EUDAMED system.

What CE does not certify:

• Bench performance of a specific unit. CE is type certification — the design and representative samples were assessed, not every manufactured unit.
• Clinical efficacy for all Indian patient populations. Clinical evaluation under the MDR is generally conducted on the populations the manufacturer declares in the intended use; Indian altitude, humidity, and patient comorbidity profiles are not specifically assessed.
• Fitness for the Indian grid, ambient, or use environment. Voltage range, humidity tolerance, and dust-environment operation are within the manufacturer’s declared operating conditions; Indian domestic conditions often sit at the edge of or outside these declarations.
• Ongoing compliance. A CE mark from 2019 indicates compliance at that date; if the manufacturer’s QMS has since deteriorated or the Notified Body has been suspended, the CE mark on the unit does not automatically reflect the current state.

CE is necessary for EU sale and is a meaningful quality signal globally, but it is not the entirety of the quality or safety picture.

The two regulatory regimes: MDD 93/42 and MDR 2017/745

Two EU regulatory regimes coexist in the Indian market through the mid-2020s, because the MDR transition has been slow.

MDD 93/42/EEC was the Medical Device Directive in force from the 1990s until 2021. It allowed medical devices to be CE-marked under a lighter-touch assessment for many classes, and was the basis for the “legacy” CE marks on devices manufactured and certified before 26 May 2021 (the MDR’s application date after multiple delays).

MDR 2017/745 is the current Medical Device Regulation. It is more stringent — tighter clinical evidence requirements, higher classification for some devices (including some respiratory equipment that moved from Class IIa under MDD to Class IIb under MDR), expanded post-market surveillance, and the EUDAMED public database for traceability. The MDR entered into application on 26 May 2021, but transitional provisions have been extended multiple times; devices with valid MDD certificates could continue to be placed on the market until as late as 31 December 2027 / 31 December 2028 depending on the device class, provided certain conditions are met (no significant design changes, continued conformity with MDD requirements, etc.).

For an Indian buyer looking at a CE mark on a device in 2026, both MDD and MDR marks are legitimate at the EU level — but they carry different levels of current assurance:

• A CE mark with a reference to the MDD 93/42 and a Notified Body certificate issued before May 2021 indicates legacy certification. The device was assessed under the older, lighter regime. If the manufacturer has not yet transitioned the device to MDR certification, the regulatory picture is current only until the relevant transition deadline.
• A CE mark referencing MDR 2017/745 with a Notified Body certificate issued from 2021 onwards indicates full current certification under the newer regime.

Neither is inherently unsafe — but the MDR certificate is the current standard, and a device whose manufacturer is still shipping on legacy MDD certification into 2026 is one the buyer should at least verify is on track to transition. An MDD-only device that exits the EU market in 2027–28 because its manufacturer could not or did not transition is one that will have weakened post-market support thereafter.

When to be suspicious of an MDD-era CE mark: when the device is being sold at a deep discount and the manufacturer has no clear MDR transition timeline on their website, when the Notified Body that issued the original MDD certificate is no longer listed as a current designated body, or when the device’s classification under the MDR would be higher than it was under the MDD (meaning the manufacturer would face a significantly harder re-certification path).

The Notified Body number

The CE mark on a medical device of Class Is, Im, Ir, IIa, IIb, or III is accompanied by a four-digit number. This number identifies the Notified Body that assessed the device’s conformity. Examples:

• CE 0123 — TÜV SÜD Product Service (Germany)
• CE 0197 — TÜV Rheinland (Germany)
• CE 0120 — SGS Fimko (Finland)
• CE 0086 — BSI Assurance (UK legacy; now transitioned to Netherlands under BSI Assurance NL, CE 2797)
• CE 2797 — BSI Assurance NL
• CE 2460 — DEKRA Certification (Netherlands)

The Notified Body number is the single most verifiable piece of CE labelling. The EU maintains a public database of designated Notified Bodies — NANDO (New Approach Notified and Designated Organisations) — at the European Commission’s website. For medical devices, searching NANDO by the four-digit number returns the Notified Body’s name, country, scope of designation (which product categories and which MDR / MDD annexes it is designated to assess), and current status.

The verification practice:

1. Read the four-digit number next to the CE logo on the device or packaging.
2. Search NANDO for the number.
3. Verify that the returned Notified Body’s scope of designation includes “Regulation (EU) 2017/745” (for MDR certificates) or “Directive 93/42/EEC” (for MDD legacy certificates).
4. Verify that the body’s current status is “Notified” (not “Withdrawn” or “Suspended”).
5. For Class IIa, IIb, and III medical devices, the Notified Body should be designated specifically for the device’s category (some NBs are designated for cardiovascular devices only, others for active devices, etc.).

A CE mark without a four-digit Notified Body number is only legal for Class I devices that are self-certified (non-sterile, non-measuring) — for example, a standard nasal cannula or basic humidifier bottle. An oxygen concentrator, CPAP, or BiPAP is Class IIa or IIb under EU classification (some BiPAP-ST devices for chronic use may be IIb); it must carry a Notified Body number to be legally CE-marked. A CE mark without the four-digit number on one of these devices is invalid by itself and is a strong indicator of a counterfeit.

The Declaration of Conformity (DoC)

The CE mark is the label; the underlying document is the EU Declaration of Conformity (DoC), which the manufacturer issues for each product or product family. The DoC names the manufacturer, the product, the applicable regulations, the Notified Body (if applicable), the Notified Body certificate number, and the signatory. The DoC is a one- to three-page document.

Under the MDR and MDD, the DoC must be made available to competent authorities and, in practice, to downstream purchasers on request. Reputable manufacturers publish it on their website; less reputable ones send it by email on request; counterfeit sellers cannot produce it.

The verification practice:

1. Before or at purchase, request the DoC for the specific device model.
2. Read the DoC for: manufacturer name (matches the device label), product identification (matches the device model and variant), regulatory framework (MDR 2017/745 or MDD 93/42 with transition reference), Notified Body name and number (matches the label), certificate number (traceable to the Notified Body’s register for recent certificates).
3. For EUDAMED-registered devices (mandatory under MDR), cross-check the manufacturer and device in the EUDAMED public module when available. EUDAMED implementation has been phased; the device registration and UDI modules are partly public as of 2026.

A manufacturer that cannot produce a current DoC on request is a red flag. A DoC that references an expired Notified Body certificate is a red flag. A DoC that names a Notified Body not listed in NANDO for the relevant MDR / MDD designation is a clear indicator of a counterfeit.

UKCA and the Brexit wrinkle

The UK left the EU regulatory system progressively after Brexit. For medical devices sold in Great Britain (England, Scotland, Wales — excluding Northern Ireland, which remains in the EU regulatory perimeter for devices under the Windsor Framework), the relevant mark is UKCA (UK Conformity Assessed). UKCA is broadly equivalent to CE for the transitional period and is issued under the UK Medical Devices Regulations 2002 (as amended).

The transitional arrangements have been extended multiple times. As of April 2026, CE-marked medical devices can still be placed on the Great Britain market under recognition arrangements until at least 30 June 2028 for most device classes. A new UK regulatory regime under consultation since 2022 will eventually replace this.

For the Indian buyer, UKCA is rarely the relevant mark — most imported respiratory equipment in India carries CE from the EU pathway, not UKCA from the UK pathway. But a device may carry both, particularly if the manufacturer is UK-headquartered or has a UK distribution operation. A UKCA mark alone (without CE) is a signal that the device is certified for Great Britain but not for the EU — not a problem for Indian regulatory purposes, but a narrower regulatory base.

FDA 510(k) and the US context

Similarly, devices manufactured in or imported from the United States carry US Food and Drug Administration (FDA) 510(k) clearance or Premarket Approval (PMA) documentation. FDA 510(k) is a substantial-equivalence demonstration to a predicate device; PMA is a higher-bar approval for high-risk devices. Either is a meaningful regulatory signal.

For Indian buyers, a device marked “US FDA Approved” (the common phrasing — technically, most devices are FDA-cleared via 510(k), not “approved” in the PMA sense) is a positive signal but carries the same caveats as CE: type certification, not ongoing individual-unit assurance. The FDA’s public database (FDA 510(k) and FDA Product Classification databases) is searchable and allows verification of specific 510(k) numbers.

A common pattern in Indian product listings is the claim “US FDA Approved.” Verification is the same as for CE: ask for the 510(k) number, search it on the FDA website, confirm the device and manufacturer match.

How to spot a fake CE mark

Counterfeit CE marks are well-documented in various product categories, medical devices included. The common fakes and their tells:

The “China Export” myth. A widely-circulated claim is that two CE logos exist: a genuine “Conformité Européenne” and a fake “China Export” with narrower letter spacing. This is mostly urban legend — the visual difference is tiny, and counterfeiters who bother can replicate either. Do not rely on the logo spacing as a counterfeit tell.

Missing Notified Body number. A CE mark on a Class IIa, IIb, or III medical device without a four-digit Notified Body number alongside is presumptively invalid. This is the single strongest tell.

Unverifiable Notified Body number. A four-digit number that does not match any currently or formerly designated Notified Body in NANDO is a strong counterfeit indicator. A number that matches an NB whose designation does not cover medical devices is a secondary indicator.

No Declaration of Conformity available. A reputable manufacturer produces the DoC on request. An unreachable manufacturer, a dealer who cannot escalate to the manufacturer, or a DoC that references a certificate not verifiable with the named Notified Body — any of these is a red flag.

Misspelt or misformatted certificate numbers. Genuine Notified Body certificate numbers follow a format specific to that NB. A certificate “XYZ-123456” that does not match the issuing body’s known format is suspicious.

Obviously recent certificate, obviously old-stock device. A certificate dated 2024 on a device manufactured in 2018 with no explanation is consistent with fraudulent relabelling. Manufacturing date is often stamped on the cabinet; certificate date is on the DoC.

Discrepancy between the device’s label class and the EU classification. An oxygen concentrator is Class IIa under MDD (and most are IIb under MDR). A CE mark claiming Class I self-certification on a concentrator is invalid.

What to do with the verification for an Indian-market purchase

CE verification is one layer of due diligence for an Indian buyer of an imported respiratory device. The other layers are:

1. CDSCO / MDR 2017 Indian license verification — covered in a separate article. A device with a valid CE mark but no Indian MD-15 import license is not legally importable into India and its domestic warranty / service story is likely weak.
2. Importer accountability — the Indian MD-15 importer is the legal counterparty for the buyer. CE is manufacturer-level; MD-15 is Indian-importer-level. Both need to check out.
3. Service network in India — a correctly CE-marked and MD-15-licensed device still needs in-country service infrastructure to be practically supportable. Brands with deep Indian service networks (Philips Respironics, Oxymed, BPL) are different from thinly-distributed imports.
4. Post-market action — if the EU has issued a Field Safety Corrective Action or recall on a device family, a grey-imported unit into India will not receive the corrective action. Verify the device against the EUDAMED FSCA module or the Indian CDSCO alert list before purchase.

A 10-minute verification checklist for any imported respiratory device purchase:

1. Photograph the CE mark and Notified Body number on the device.
2. Search the NB number on NANDO; confirm active designation for medical devices under MDR 2017/745.
3. Request the Declaration of Conformity from the dealer or importer. Verify manufacturer, product, and certificate number.
4. Cross-check against the Indian MD-15 license on the invoice.
5. Search the EUDAMED public module (as available) for the manufacturer and device.
6. Check the EUDAMED / Indian CDSCO alerts module for any current FSCA or recall on the device family.

Edge cases and red flags

“CE tested” vs “CE certified.” A device listed as “CE tested” is not necessarily CE certified — “tested” can mean the manufacturer submitted samples to a lab, without formal certification by a Notified Body. Certification is the legal condition for CE marking; testing alone is not.

Generic imports through e-commerce. A concentrator listed on a major marketplace as “CE certified” with no manufacturer name, no importer name, no MD-15 number, and a suspiciously low price (40%+ below mainstream channel) is almost always grey-market at best, counterfeit at worst. The marketplace’s liability protection does not extend to verification of the claims.

Second-hand imported units. A second-hand Philips, ResMed, or Inogen device imported by an individual (“personal effect” or small-trader import) may be genuinely CE-marked by the manufacturer but imported outside the MD-15 framework in India. The CE is real; the Indian regulatory story is absent. This is not illegal for personal use, but is a very different market-support position from a formally imported unit.

CE mark on the box but not on the device. Genuine CE marking requires the mark on the device itself (or, for devices too small, on the packaging per the regulation). A box with CE on it and a device without is a mismatch that warrants scrutiny.

Refurbished units with CE from original certification. A refurbished unit retains the original CE marking if the refurbishment does not materially change the device. Significant refurbishment — e.g., installation of non-OEM compressor or sieve beds — may invalidate the original CE. In practice, Indian refurbishers rarely address this.

Closing

CE verification is not hard and is genuinely meaningful. A device with a verifiable, current, MDR-regime CE mark from a designated Notified Body, a valid Declaration of Conformity from the manufacturer, and an Indian MD-15 import license from the named importer, is a device with real regulatory footing. A device missing any of those four pieces is a device where the buyer is assuming risk that can be priced out with 15 minutes of verification work.

In the Indian respiratory equipment market, the authorised-channel devices from mainstream brands almost always pass this verification. The failures concentrate in grey-market imports, e-commerce-listed unknown brands, and second-hand refurbished units without importer provenance. The verification is not about catching the top of the market; it is about filtering the bottom.

Consult a qualified regulatory professional if a specific device’s CE or MDR status is materially in dispute; this article is a practical verification guide, not legal advice.

Background references: Regulation (EU) 2017/745 on medical devices [CITATION]; Directive 93/42/EEC (legacy MDD) [CITATION]; Regulation (EU) 2023/607 on extended MDR transition [CITATION]; EU NANDO database for Notified Body designations [CITATION]; EUDAMED database public modules [CITATION]; UK Medical Devices Regulations 2002 (as amended) and MHRA transition timeline [CITATION].