Launch PPE in the EU & UK Market, without drowning in CE marking complexity
Your PPE saves lives, but CE marking stops it from reaching workers. Most manufacturers waste 6-12 months in Notified Body queues and €15K-€30K on wrong tests. We get it right from day one: correct category classification, coordinated testing, compliant documentation. Launch 7-10 weeks faster. Save €8K-€30K.
Why SMEs Choose EcoComply
- Wrong risk category = wasted €20K and 6-month restart
- 6-12 month Notified Body waitlists
- Uncoordinated labs, testing, documentation
- Technical files built in crisis mode
- Failed submissions requiring re-testing
- No legal shield when authorities inquire
- Applicability and standards defined upfront, no ambiguity
- Testing scope locked before engaging labs
- One coherent compliance path across directives
- Labs, suppliers, and documentation coordinated in one system
- Technical Files built continuously and kept audit-ready
- Certified EU and UK Authorised Representation
- A single, accountable contact point for regulators and authorities
- Expert validation at critical steps, without building an internal team
What your product must comply with
We guide you through all critical regulations for your product launch
CE Marking
Essential for all products entering EU market
EMC
Electromagnetic compatibility requirements
RoHS
Restriction of hazardous substances
RED
Radio equipment directive compliance
Batteries regulation
New battery sustainability rules
Digital Product Passport (DPP)
Mandatory product lifecycle data
EcoDesign & Energy Efficiency
Environmental design requirements
CSRD (carbon footprint)
Product carbon impact disclosure
REACH
Substance restriction in PPE materials
WEEE / EPR Packaging
Waste and packaging responsibility
EU Cybersecurity (CRA)
Connected device security standards
Sustainability Requirements
Environmental sustainability mandates
We handle compliance. You ship.
You don’t need to become a compliance expert.
EcoComply takes ownership of your certification - with automation for speed and experts for the critical decisions.
- One dedicated expert who knows your product
- Clear steps, no back-and-forth
- Labs, documents, and authorities coordinated for you
- Issues caught early, before they block your launch
So compliance gets done, without slowing your business.
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How EcoComply works
You tell us about your product.We take care of compliance, step by step, until you’re ready to sell.
Product Assessment
Know exactly what applies and how long it will take.
We assess your product and market to identify applicable requirements, gaps, and critical timelines.You get a clear roadmap: what’s required, what’s missing, and what to do next.
Manual Review or Drafting
Compliant manuals - reviewed or written for you.
We review your user manuals, safety instructions, warnings, symbols, and translations against EU & UK requirements.
If anything is missing or non-compliant, we correct or draft regulator-ready manuals accepted by authorities.
Testing & Lab Coordination
The right tests, with the right labs - no back and forth.
We define the testing scope, select accredited labs, coordinate schedules, and manage communication.
No unnecessary tests. No confusion. No wasted time.
Supplier data collection / review
We chase suppliers - you don’t.
We collect and validate supplier declarations, component data, and certificates required for compliance.
Everything is reviewed, tracked, and audit-ready.
Technical files in 48-72h
Complete, structured, authority-ready files.
We assemble your Technical File, including risk analysis, test reports, manuals, supplier data, and traceability.
Digital product passport
Future-proof your compliance.
We structure your product data to meet upcoming Digital Product Passport requirements, so you don’t redo the work later.
Post-Market Surveillance compliance & Authorised Representation
Stay compliant after launch.
We monitor regulatory changes, maintain your documentation, and act as your EU & UK authorised representative (if requested), handling authority requests after launch.
Rsults for small & mid-size PPE manufacturers
See the real number-driven impact from companies who chose EcoComply.
Launch in EU 7-10 weeks
Save €8K-€30K on re-testing, wrong notified bodies, emergency consultants
Free up 40+ hours on managing vendors and chasing documentation
Fully compliant, without building an internal compliance team
Frequently Asked Questions
Everything you need to know about EU compliance
CE marking proves compliance with EU Regulation 2016/425, required for all EU sales.
Category I PPE (minimal risk) = self-declaration.
Category II/III = Notified Body certification required.
For Category III, CE mark must include Notified Body's ID number.
Note: CE marking confirms regulatory compliance, not quality.
Category I: 2-4 weeks (self-certification).
Category II: 3-5 months (Notified Body type-examination).
Category III: 5-8 months (type-examination + surveillance setup).
Main delays: incomplete technical files (adds 2-4 months), Notified Body backlogs (adds 6-12 months), wrong risk category (forces restart).
CE = EU market access (27 countries + Northern Ireland).
UKCA = Great Britain access (England, Scotland, Wales).
Since August 2024, UK accepts CE marking indefinitely for PPE, but this could change. Smart manufacturers get both to hedge policy risk. Requirements are nearly identical; separate bodies needed.
Category I: No.
Category II: Yes (Module B type-examination only).
Category III: Yes (Module B + ongoing Module C2/D surveillance).
All certificates expire after 5 years, renewal requires 6-12 month advance notice. Cost: €8K-€15K for Module B, plus €3K-€10K annually for Category III surveillance.
Verify on EU NANDO database: (1) Notified under Regulation 2016/425, (2) Specifically notified for your product type (respiratory ≠ gloves ≠ footwear), (3) Capacity/lead times (request written timeline commitments), (4) Specialization in your PPE type, (5) Dual EU/UK accreditation if pursuing both markets.
Red flag: "voluntary certificates" from non-notified bodies have zero legal value.
Your PPE Protects Workers. But First, It Needs CE Marking
Book a free consultation. We'll analyze:
- Exact risk category (I, II, or III) for your products
- Which harmonized standards apply
- Realistic timeline and costs
- Whether you're working with the right Notified Body
No sales pressure. Just regulatory expertise.
