Who this service is for

You are a MedTech company (Class I to III, or IVD) preparing for or holding CE marking, with no qualified PRRC in-house.

You are a startup between Seed and Series B — you need the role filled properly, but a full-time regulatory hire is premature.

You are a non-EU manufacturer whose Authorised Representative has reminded you that the PRRC is a separate, additional requirement.

Your PRRC has just left, and you need qualified interim coverage before your next notified body interaction.

The problem

Article 15 is not optional and not a formality. Notified bodies now routinely verify the PRRC’s qualifications and designation at audit, and an unfilled or under-qualified PRRC role is a finding that can delay certification or trigger follow-up.

The qualification bar is specific: a relevant degree plus one year of regulatory or QMS experience, or four years of experience without the degree. Most early-stage teams have nobody who meets it — and a full-time PRRC costs €90,000–130,000 a year fully loaded.

Naming a founder who does not meet the criteria, or a consultant who signs but never looks at your QMS, creates a different problem: the PRRC carries personal responsibility, and a paper appointment will not survive scrutiny.

What QLE does

We act as your formally designated PRRC — named in your QMS, with a documented qualifications file your notified body can inspect.

We review release documentation and sign off regulatory declarations within agreed turnaround times.

We run a monthly compliance call and review regulatory correspondence as it arrives.

On higher tiers: quarterly QMS reviews, notified body liaison, CAPA and deviation review, post-market surveillance oversight, and audit attendance.

Deliverables

PRRC designation letter and qualifications file — signed pack at onboarding.

Monthly compliance call with written minutes.

Regulatory correspondence review — as received.

Quarterly QMS review report (Growth tier and up).

Post-market surveillance oversight summary — quarterly (Growth and up).

Audit attendance — as scheduled (Scale tier).

Regulatory basis

EU MDR 2017/745, Article 15 — every manufacturer must have a qualified PRRC; micro and small enterprises must have one permanently and continuously at their disposal.

EU IVDR 2017/746, Article 15 — the equivalent obligation for IVD manufacturers.

MDCG 2019-7 (rev.) — guidance clarifying PRRC qualifications, outsourcing conditions, and the separate PRRC requirement for authorised representatives.

How an engagement starts

1. Intro call — device class, QMS status, notified body situation.

2. Fixed-fee proposal with the right tier and any onboarding work identified.

3. Onboarding: designation letter, QMS access, qualifications file handed over.

4. Steady state: monthly calls, reviews and sign-offs per tier.

5. Designation is usually live within two weeks of signature. If you have an audit or submission imminent, say so on the intro call — accelerated onboarding is possible.

   Pricing

   Starter — from €1,500/month.

   Monthly compliance governance call, review of regulatory correspondence, and PRRC review of EU Declaration of Conformity / technical documentation status. Final legal responsibility for declarations and product conformity remains with the manufacturer.

   Growth — from €3,000/month.
   Everything in Starter plus quarterly QMS compliance review, notified body liaison support, CAPA review, and PMS compliance oversight.

   Scale — from €5,500/month.
   Everything in Growth plus active QMS management, audit attendance, board-level reporting and priority advisory.

   What moves the price: device class and count, notified body activity in the period, QMS maturity, and whether FDA or UKCA tracks run in parallel. Every retainer has a defined hour envelope; work beyond scope is quoted first, never billed by surprise.

   What this service is not

   QLE is not a notified body, a law firm or a certification body, and the PRRC role does not replace your Authorised Representative if you are outside the EU — we offer that separately. We do not act as PRRC and internal auditor for the same QMS: auditor independence under ISO 13485 requires those to be different people.