CE Marking Cost / CE Certification

CE mark and UKCA certification cost: what it costs by product, including medical devices

The EU charges nothing for the CE mark itself. What you pay for is the testing, the technical documentation and, where your product needs one, a notified body. Below are the published ranges by product type, what drives the cost of a CE mark for a medical device, and what UKCA adds if you also sell in Great Britain.

Last updated 21st October 2026 · By Vas Parshin and Anabel Amar

CE Marking Cost 2026: What CE Certification Costs, and When a Notified Body Is Needed

€400 – €800Published CE cost for simple battery or DC-powered electronics

€13,000 – €25,000+Published CE cost for a medical device

€5,000 – €15,000+Notified body fee, where one is required

CE mark certification cost, by published range

"CE certification cost", "CE mark certification cost" and "CE marking cost" are usually the same question: the sum of these line items for your product. A notified body fee only applies where the rules for your product require one.

Item	Published range
Technical documentation (in-house or outsourced)	€500 – €3,000+
Accredited lab testing, per scope	€500 – €5,000+
Compliance consultant / project management	€1,000 – €5,000+
Simple battery/DC-powered electronics	€400 – €800
Standard AC-powered electronics	€750 – €1,500
Wireless product (RED)	€1,500 – €3,000+
Medical device	€13,000 – €25,000+
Notified body fee, where required	€5,000 – €15,000+

A calculator, a printed quotation and a product prototype on a desk — Illustration: pricing up the testing for a new product.

What a CE mark costs for a medical device

The published range for a medical device is €13,000 – €25,000+, but under the EU Medical Device Regulation (EU) 2017/745 the device's class decides most of that number, because it decides whether a notified body is involved and how much of your documentation it reviews.

Device class (EU MDR)	Who assesses conformity
Class I, not sterile, no measuring function, not a reusable surgical instrument	The manufacturer, after drawing up the technical documentation, issues the EU declaration of conformity. No notified body.
Class I sterile, with a measuring function, or a reusable surgical instrument	A notified body, limited to the sterility, metrology or reuse aspects.
Class IIa	A notified body, assessing the technical documentation of at least one representative device per category.
Class IIb	A notified body, assessing at least one representative device per generic device group. For implantable IIb devices (other than sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips and connectors) it assesses the technical documentation of every device.
Class III	A notified body, under Annex IX or Annexes X and XI.

Notified body fees are not a secret. Article 50 of the MDR requires every notified body to establish a list of its standard fees and make it publicly available, and the European Commission publishes a consolidated list of links to those fee schedules, last updated 13th July 2026. Comparing two or three of them against your device's class is a more reliable budget than any single published range.

UKCA certification cost, by published range

One UK-based lab publishes flat reference test rates of $600 for low-voltage products and $660 for high-voltage products, describing them as "for reference only" — actual cost depends on the specific product, and wireless-enabled products are quoted separately by radio function and Bluetooth version. That figure is a single test line, not documentation, technical file work, or (where applicable) a conformity assessment body's own fee.

The biggest cost driver: whether a notified body is involved at all

Each EU product law fixes which conformity assessment procedures, or "modules", a manufacturer may use, and the module decides whether a notified body fee appears on the bill. Under Module A, internal production control, which covers both design and production, the manufacturer itself ensures the product conforms, with no EU-type examination by a third party. Modules such as B, EU-type examination, bring a notified body in, and that is where the notified body line in the table above comes from.

Radio products show how much this depends on decisions made at the test-planning stage. Under the Radio Equipment Directive 2014/53/EU, the health, safety and electromagnetic compatibility requirements of Article 3(1) can always be shown through internal production control (Annex II). For the Article 3(2) spectrum requirement and the Article 3(3) requirements, Annex II is available only where the manufacturer has applied harmonised standards whose references are published in the Official Journal. Where it has not applied them, has applied them only in part, or no such standards exist, the equipment must go through EU-type examination (Annex III) or full quality assurance (Annex IV), and both involve a notified body. For the Article 3(3) cybersecurity requirements that now apply to many connected radio products, see EU RED cybersecurity requirements; RoHS evidence, another part of the same technical file, is covered in RoHS exemption expiry dates.

Why these numbers are hard to compare to a real project

Every range above answers a different, narrower question — one lab's test fee, one consultant's documentation quote — and none of them is what a product actually costs to get to market across CE, UKCA and (usually) FCC at the same time, scoped once instead of three separate quotes with three separate timelines. That's the number that actually matters when you're planning a launch budget.

Indicative reference points, reviewed as we complete more projects, rather than a rate card: £1,500 – £1,600 for one CE-RED Bluetooth test and £4,500 to add a Bluetooth function to an already-certified product; £3,800 – £4,200 for a CE-RED, UKCA and FCC bundle on a Bluetooth-only product, £8,000 – £8,800 for the same bundle on a Wi-Fi dual-band, battery-powered, connected product, and £9,600 – £10,600 with EN 18031-3 cybersecurity added; £6,100 – £6,800 for the Bluetooth bundle extended to Oman and the UAE, £22,000 – £24,300 for the Wi-Fi bundle extended to Mexico, Brazil, Kuwait and Israel, and £14,000 – £26,500 for a multi-region programme including markets such as Japan, Australia, Korea or China. See the interactive estimator →

The actual GB status, deadline by deadline

The Product Safety and Metrology etc. (Amendment) Regulations 2024, in force since 1st October 2024, recognise CE marking indefinitely in Great Britain for a wide range of product regulations — toys, radio equipment, machinery, RoHS-covered electrical equipment, ecodesign and civil explosives among them. There is currently no announced date on which CE acceptance ends for these categories, and businesses can use either CE or UKCA. Construction products go further still: CE marking continues with no end date at all, per a September 2024 government announcement.

Medical devices and IVDs are the exception. General medical devices compliant with the EU MDD or AIMDD can be placed on the Great Britain market until 30th June 2028 or the certificate's expiry, whichever is sooner. Devices compliant with the EU MDR, and IVDs compliant with the EU IVDR, can be placed on it until 30th June 2030; IVDs compliant with the EU IVDD until 30th June 2030 or certificate expiry, whichever is sooner. In its response to the MHRA consultation, published on 21st October 2026, the government said it intends to recognise CE-marked devices certified under the EU MDR and EU IVDR indefinitely, and to accept EU MDD-compliant devices until the end of the EU transition period (currently 31st December 2028). Those changes still need parliamentary approval and are due before 30th June 2028; until they are made, these dates stand.

The one dated change that applies broadly, for products that do carry the UKCA mark: until 11pm on 31st December 2027 the mark may sit on a label or accompanying document; from 1st January 2028 it has to be applied directly to the product itself where size allows. That's a placement rule, not a reason CE stops being accepted.

Questions

How much does CE marking (CE certification) cost?

The EU charges nothing for the CE mark itself; the cost is the work behind it. Published ranges vary widely by product type: technical documentation typically runs €500-3,000+, accredited lab testing €500-5,000+ per scope, and a compliance consultant €1,000-5,000+. Simple battery-powered electronics can clear CE for €400-800; a wireless (RED) product is usually €1,500-3,000+; a medical device is €13,000-25,000+. Where a notified body is required, add €5,000-15,000+. These are published third-party rates for isolated line items, not a scoped programme price.

How much does a CE mark for a medical device cost?

One published range puts a medical device at €13,000-25,000+, but the device class decides most of it. Under the EU MDR, a class I device that is not sterile, has no measuring function and is not a reusable surgical instrument is self-declared by the manufacturer after drawing up the technical documentation, with no notified body. Class IIa, IIb and III devices go through a notified body's conformity assessment, and for most class IIb implantables the notified body assesses the technical documentation of every device rather than one representative device per group. Notified bodies must publish their standard fees (MDR Article 50), and the European Commission keeps a consolidated list of those fee schedules, last updated 13th July 2026.

How much does UKCA certification cost?

One UK lab publishes reference testing rates of $600 for low-voltage products and $660 for high-voltage products, with wireless-enabled products priced separately depending on the radio functions involved. As with CE, this is a single test-line rate, not the full cost of documentation, technical file and any required conformity assessment route.

Is CE marking still accepted in Great Britain?

Yes, and for most product categories there is no end date. The Product Safety and Metrology etc. (Amendment) Regulations 2024, in force since 1st October 2024, recognise CE marking indefinitely for toys, radio equipment, machinery, RoHS-covered electrical equipment, ecodesign and civil explosives, among others. UKCA remains a legal alternative, not a replacement, for these categories.

Which products still have a CE-to-UKCA deadline?

Medical devices and IVDs are the main exception. General medical devices compliant with the EU MDD or AIMDD can be placed on the Great Britain market until 30th June 2028 or the certificate's expiry, whichever is sooner; devices compliant with the EU MDR, and IVDs compliant with the EU IVDR, until 30th June 2030; IVDs compliant with the EU IVDD until 30th June 2030 or certificate expiry, whichever is sooner. In its response to the MHRA consultation, published on 21st October 2026, the government said it intends to recognise CE-marked devices certified under the EU MDR and EU IVDR indefinitely, and to accept EU MDD-compliant devices until the end of the EU transition period (currently 31st December 2028). Those changes still need parliamentary approval and are due before 30th June 2028; until they are made, the dates above stand. Construction products are the opposite case — CE marking continues with no end date at all, by a September 2024 government announcement.

What actually changes on 1st January 2028?

For products that do carry the UKCA mark, a labelling rule changes: until 31st December 2027, the UKCA mark may sit on a label or an accompanying document rather than on the product itself. From 1st January 2028, it must be applied directly to the product where its size allows. This is a marking-placement rule, not a deadline for CE acceptance to end.

Do I always need a notified body for CE marking?

No. Many products can be CE marked under Module A, internal production control, where the manufacturer itself ensures conformity with no EU-type examination, so there is no notified body fee. Whether a notified body is needed depends on the product law and the route taken. Under the Radio Equipment Directive, for example, the Article 3(2) and 3(3) requirements can be met without a notified body only where the manufacturer has applied harmonised standards published in the Official Journal; otherwise EU-type examination (Annex III) or full quality assurance (Annex IV) applies.

Where we fit

The published rate-card numbers above are real, but they're quotes for isolated line items — a test here, a document there — collected from however many labs and consultants you end up talking to separately. We scope CE, UKCA and FCC as one programme against your actual product, so the number you get is the number you pay, not the first of several.

Get a scoped number