EC REP Pricing

EC REP Cost Calculator

Estimate your annual EU Authorized Representative fee based on portfolio size, device risk class, and target markets. Instant result — no email required.

The three EC REP pricing models

EC REP providers typically charge using one of three structures. Understanding which model applies to your situation helps you identify the most cost-effective option before requesting quotes.

Model	How it works	Best for	Typical range
Flat fee	Fixed annual amount regardless of SKU count	5+ devices, growing portfolio	€600–5,000/year
Per-device	Charged per product certificate or SKU per year	1–3 devices	€300–800/device/year
Hybrid	Flat fee base + surcharge above a SKU threshold	Mid-size portfolios	€1,000–4,000/year

Calculate your EC REP cost

Use the calculator below to get an indicative annual fee range based on your specific situation. Adjust the inputs to match your portfolio and coverage requirements.

Number of products / SKUs requiring EC REP Highest device risk class in portfolio Target markets PRRC (Person Responsible for Regulatory Compliance) needed?

Estimated annual EC REP cost

What affects EC REP pricing the most?

Portfolio size is the primary cost driver. The number of distinct SKUs covered under the EC REP agreement has the single largest influence on annual fees. A manufacturer with 30 devices typically pays 3–5x more than one with 3 devices, regardless of risk class. If you are launching a new product line, it is worth asking providers how incremental SKU additions are priced before signing a flat-fee contract.

PRRC is a legal requirement under MDR Article 15 — not an optional add-on. Every manufacturer placing medical devices on the EU market must have at least one Person Responsible for Regulatory Compliance on their team. If your company lacks a qualified PRRC, your EC REP can provide this function — but it adds meaningful cost because the PRRC carries personal regulatory liability. Outsourcing PRRC to the EC REP is common among small non-EU manufacturers with no EU-based staff.

How much does an EU Authorized Representative cost per year?

EC REP annual fees range from approximately €400 to €15,000 depending on portfolio size, device risk class, and coverage markets. A small manufacturer with 1–3 Class I or IIa devices in EU only can expect to pay €400–1,500/year. A mid-size manufacturer with 10–20 devices including Class III in EU + UK should budget €3,000–8,000/year.

Prices at the lower end typically reflect per-device contracts from smaller boutique providers, while higher fees are associated with global compliance firms offering integrated PRRC, EUDAMED management, and post-market surveillance support.

Is there a cheap EU authorized representative for small manufacturers?

Yes. Smaller dedicated EC REP providers offer flat-fee contracts starting at €400–800/year for manufacturers with 1–5 devices. Per-device pricing models are typically more expensive for larger portfolios but cheaper for single-product companies. Using a matchmaking platform like ECP allows you to receive competitive quotes from multiple EC REP providers simultaneously without individually researching and approaching each one.

When comparing low-cost options, check the provider's liability insurance coverage, EUDAMED registration experience, and responsiveness to market surveillance inquiries — the cheapest option is not always the safest one.

What factors increase EC REP cost?

The main cost drivers are: number of SKUs in the portfolio, device risk class (Class III and IVD Class D attract higher fees due to liability exposure), geographic coverage (EU + UK + CH costs 40–60% more than EU only), whether PRRC services are included, and the EC REP's liability insurance tier.

Contract length can also affect pricing — multi-year agreements often unlock discounts of 10–20% compared to annual rolling contracts. Providers with a large existing client base in your device category may also offer more competitive rates due to shared compliance infrastructure.

Get actual quotes from EC REP providers

Submit one request on ECP and receive proposals from multiple EU Authorized Representative providers. Free and without commitment.