Transparent pricing. Defined scope. No open-ended billing. Our primary services — UKRP and EC-REP appointments — are structured as fixed annual fees. You know what you pay before you sign.
UKRP and EC-REP appointments are priced as fixed annual fees, agreed before the mandate is signed. The fee covers the appointment itself, the registration maintenance, regulatory correspondence management, vigilance reporting, and defined support throughout the year.
There is no additional charge for routine regulatory correspondence, vigilance reports within normal volume, or MHRA/competent authority liaison within the agreed scope. Extraordinary scope — for example, a significant product recall or a major regulatory submission — is agreed separately and quoted in advance.
To receive a fee proposal: submit an enquiry with your device range and target markets. We will provide a written fee proposal within three working days.
Registration activities are priced as fixed project fees where the scope is clearly defined.
EUDAMED actor registration | Fixed fee. Includes SRN registration, actor record configuration, and initial verification. |
EUDAMED device registration | Fixed fee per device or device bundle. Includes Basic UDI-DI, UDI-DI configuration, and initial data entry. Ongoing maintenance included in EC-REP retainer or available as standalone. |
MHRA device listing | Fixed fee. Included within UKRP appointment fee or available standalone for manufacturers with an existing UKRP. |
MDR/IVDR gap analysis | Fixed fee. One defined review with a written output. Scope confirmed before commencement. |
MDSAP readiness assessment | Fixed fee. Gap analysis against IMDRF audit model with written findings. Preparation and mock audit quoted separately. |
ESOS compliance assessment | Fixed fee. Scope confirmed before commencement. Qualifies your organisation for ESOS Phase 3 compliance route selection. |
ISO 50001 support | Phased fixed fees or day rate depending on scope. Quoted after initial scoping conversation. |
Second-party audit | Fixed fee per audit. Includes pre-audit review, one-day on-site or remote audit, formal report. |
Day rate — general | Where scope is variable (e.g. multi-phase programmes, ongoing support). Range: £650–£1,100 per day depending on service type. Always confirmed in writing before work commences. |
Notified Body application fees or NB-related charges
We’re dedicated to enhancing governance and compliance in healthcare and energy sectors. Let’s work together to navigate challenges and drive sustainable outcomes.
