CE Marking Under the New EU Medical Device Regulation (MDR)

We were selling into the EU with an old CE certificate issued under the MDD (Medical Device Directive). The MDR (Medical Device Regulation) replaced it in May 2021 with a 4-year transition period ending May 2027. If we don’t comply by then, we lose access to the entire EU market.

The MDR is not an update — it’s a fundamentally more demanding regulation. Our Notified Body told us the transition from MDD to MDR would require 6-9 months of work and approximately €40,000-60,000 in certification costs.

Here’s what LED therapy brands need to know about the MDR transition.

MDD vs. MDR: Why It’s Different

Aspect	MDD (Old)	MDR (New)
Scope	“Medical device” loosely defined	Stricter definitions, includes more products
Classification	More devices in lower risk classes	Reclassified many devices to higher risk
Clinical evidence	Could rely on literature review	Requires clinical evaluation plan + clinical data
UDI	Not required	Unique Device Identification mandatory
Post-market surveillance	Basic PMS plan required	Comprehensive PMS with periodic reports
Notified Body capacity	Plenty of capacity	Severe shortage — 2+ year wait times
Technical documentation	Reasonably straightforward	Much more detailed requirements

For LED therapy devices: Under MDD, many LED devices were Class I (self-certified). Under MDR, some are reclassified to Class IIa, which requires Notified Body involvement.

Classifying Your LED Device Under MDR

Classification rules (Annex VIII):

Class I: Low-risk devices. Self-declaration of conformity possible. Examples: LED devices making only general wellness claims with no medical indication.
Class IIa: Medium-risk devices. Requires Notified Body assessment. Examples: LED devices making specific skin treatment claims (acne, wound healing, wrinkle reduction with clinical mechanism).
Class IIb: Higher-risk devices. Requires Notified Body assessment with design examination. Examples: LED devices implanted or used in direct contact with sensitive tissues.

Most LED therapy devices targeting skin conditions fall into Class IIa under MDR. If your device was Class I under MDD, you may be Class IIa under MDR.

The implication: Class IIa requires a Notified Body to assess your technical documentation and quality management system before you can CE mark. You can’t self-declare.

Notified Body Availability

This is the biggest practical challenge. The MDR significantly increased the workload for Notified Bodies, and there aren’t enough of them.

Current situation (2025):

Number of Notified Bodies designated under MDR: approximately 40
Many are not accepting new clients
Those accepting clients have 18-30 month wait times for assessment
Focus is on high-risk devices (Class III, Class IIb) first

For LED therapy (Class IIa):

Some Notified Bodies are accepting Class IIa applications
Wait time: 12-24 months from application to certificate issuance
Cost: €20,000-40,000 for the initial assessment
Annual surveillance: €5,000-15,000

What we did: We started our MDR transition 18 months before our MDD certificate expires. Our Notified Body gave us a timeline of 14 months to complete the transition. We started early and still felt rushed.

Clinical Evaluation Under MDR

Under MDD, a literature review was often sufficient for clinical evidence. Under MDR, you need a structured clinical evaluation plan and supporting clinical data.

MDR clinical evaluation requirements:

1. Clinical Evaluation Plan (CEP): Documented plan describing how you’ll evaluate clinical safety and performance

2. Clinical data: Either from your own clinical investigation, or from literature/equivalent devices

3. Clinical Evaluation Report (CER): Comprehensive analysis of all clinical data

4. Post-Market Clinical Follow-up (PMCF): Ongoing data collection after market placement

For LED therapy devices:

A systematic literature review of published studies on LED light therapy for your intended use
If literature is insufficient, you may need your own clinical study
The CER must be updated annually (or more frequently if new data emerges)

Our clinical evaluation approach:

Systematic literature review: 47 studies identified, 23 met inclusion criteria
One post-market clinical follow-up study with 50 users (3-month follow-up)
Annual CER update incorporating any new published studies
Total cost: €15,000-25,000 (initial) + €3,000-5,000/year (updates)

Unique Device Identification (UDI)

MDR requires every device to have a UDI:

UDI-DI: Device identifier (product level) — assigned by the manufacturer
UDI-PI: Production identifier (batch/serial number, expiry date)

Practical implementation:

Register in the EUDAMED database (EU’s device registration system)
Print UDI on device labeling and packaging
Include UDI in all regulatory documentation

Cost: €2,000-5,000 for initial EUDAMED registration and UDI system setup.

Quality Management System: ISO 13485 Under MDR

MDR requires a quality management system. For most manufacturers, ISO 13485 is the standard.

If you already have ISO 13485 for FDA compliance:

Good news: much of the system translates directly
Bad news: MDR adds specific requirements that ISO 13485 alone doesn’t cover (PMS, clinical evaluation, UDI, etc.)
Gap analysis needed to identify MDR-specific requirements

If you don’t have ISO 13485:

You’ll need to implement the full system before MDR certification
Timeline: 6-12 months for implementation + certification audit
Cost: €15,000-30,000 for consulting + certification audit fees

Post-Market Surveillance (PMS)

MDR requires a comprehensive PMS system:

Required elements:

PMS plan (documented strategy for collecting and analyzing post-market data)
Periodic Safety Update Report (PSUR) — annually for Class IIa
Vigilance reporting (reporting serious incidents to authorities within specific timeframes)
Trend reporting (analyzing patterns in complaints and adverse events)

Our PMS system:

Customer complaint tracking database (integrated with our QC system)
Monthly complaint analysis review
Annual PSUR compiled and submitted to our Notified Body
Incident reporting system with automatic flagging for serious events
Cost: €5,000-8,000/year to maintain

Labeling Requirements

MDR has specific labeling requirements for Class IIa devices:

CE marking with Notified Body number (4-digit)
Device classification and intended use
Manufacturer details (name, address, authorized representative)
UDI
Warnings and precautions
Sterilization information (if applicable)
Lot/batch number and expiry date
“Consult instructions for use” symbol

Language requirements: Labeling must be in the official language(s) of each EU member state where the device is sold. This means multiple language versions of your packaging and user manual.

Our labeling approach:

We produce packaging in 8 languages (EN, DE, FR, ES, IT, NL, PL, SV)
The base packaging is English with a multi-language insert
Cost per language version: $800-1,500 for translation and typesetting

What It All Costs

Total MDR transition cost for an LED therapy Class IIa device:

Item	Cost
Notified Body initial assessment	€20,000-40,000
Clinical evaluation (initial)	€15,000-25,000
ISO 13485 implementation (if needed)	€15,000-30,000
Technical documentation preparation	€10,000-20,000
UDI system and EUDAMED registration	€2,000-5,000
Labeling updates (multi-language)	€3,000-6,000
Regulatory consulting	€10,000-20,000
Initial total	€75,000-146,000

Annual ongoing costs:

Item	Annual Cost
Notified Body surveillance	€5,000-15,000
Clinical evaluation update	€3,000-5,000
PMS and PSUR	€5,000-8,000
ISO 13485 surveillance audit	€3,000-5,000
Authorized representative (required)	€2,000-5,000
Annual total	€18,000-38,000

The Bottom Line

The EU MDR is significantly more demanding than the old MDD. For LED therapy brands selling into Europe, the transition requires serious time (12-24 months) and money (€75K-150K initially, €18K-38K annually).

Start now. The May 2027 transition deadline sounds far away, but Notified Body capacity is limited and the process is long. If you wait until 2026, you may not find a Notified Body with capacity to assess your device before the deadline.

The alternative: If your device is truly Class I (general wellness only, no medical claims), you may be able to self-certify under MDR. But if you’re making any treatment claims — acne, wrinkle reduction with mechanism-based claims, pain relief — assume you’re Class IIa and plan accordingly.

The EU market is the second-largest for LED therapy devices after the US. Losing access because of regulatory non-compliance is a costly mistake that’s entirely preventable.