Your regulatory guide in the European Union

 QLE Group is a Belgian regulatory consultancy agency. Based within the European Quarter of Brussels.
We act as PRRC, EU Authorised Representative, GDPR Article 27 Representative, Data Protection officer (DPO) and GPSR Responsible Person for medical device, AI and technology companies selling into the EU — and we do the compliance work behind those roles.

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One Brussels partner for MDR, IVDR, AI Act, GDPR and GPSR obligations.

QLE Group is a regulatory, compliance and consultancy firm in Brussels, Belgium. We serve as the legally required EU representative and compliance function for companies inside and outside the Union — covering medical devices (EU MDR 2017/745, IVDR 2017/746), artificial intelligence (EU AI Act), data protection (GDPR), and consumer products (GPSR). Clients include medical device manufacturers, AI and software companies, importers, and non-EU businesses entering the European market.

Our Services

  • A named Person Responsible for Regulatory Compliance under Article 15 EU MDR/IVDR — for manufacturers and authorised representatives without in-house capacity.

  • ISO 13485 QMS design, gap assessment, and implementation by a practitioner who builds and runs one on a live device today.

  • Internal and supplier ISO 13485 audits by a certified Lead Auditor, delivering the independence and inspection-ready reports your notified body expects.

  • PMS plans, PSUR/PMSR authorship, literature surveillance, and vigilance standby, run as a system aligned to MDCG 2025-10.

  • Drafting, review, and gap remediation of Annex II/III technical files, structured for notified body submission.

  • We act as your Authorised Representative under MDR, with EUDAMED registration, labelling review and vigilance support for non-EU manufacturers; as well as non-EU providers of AI systems, where the AI Act requires it.

  • Risk classification, gap assessment, technical documentation and conformity support for providers and deployers of AI systems under the EU AI Act.

  •  An outsourced Data Protection Officer under Articles 37–39 GDPR — practical, named, and proportionate to your processing.

  • The mandatory EU representative for non-EU companies that process personal data of people in the Union.

  • ItIndependent regulatory expert opinion for disputes and litigation involving medical devices and EU compliance.

  • Pragmatic ESG reporting and compliance support for SMEs facing EU sustainability requirements.

  • Proposal and compliance support for EU research and innovation funding.

Work With Us

 A boutique alternative to the big firms — and a serious alternative to the letterbox providers

Senior expertise, no handovers. The person who scopes your engagement does the work. No account managers, no juniors learning on your file.

Fixed fees, published openly. Retainers and project fees are quoted in advance, with “from” pricing on every service page. No hourly meters running in the background.

MDR and AI Act under one roof. Medical AI companies normally need two advisers. QLE covers conformity under EU MDR and the EU AI Act in a single engagement.

Representation with real oversight. A representative mandate is a legal accountability, not a mailbox. We review what we sign, and we tell you when something is not compliant.

Who you'll be working with

QLE is a specialist regulatory firm built around a senior-led model. Every engagement is scoped, quality-reviewed and signed at principal level — and where a project needs additional capacity, we bring in vetted specialists working under the same quality system. You get the responsiveness of a boutique with the depth to staff real projects.

Led by Radoslav Milkov —  QLE Principal • External Expert for the European Commission
• EU Regulatory & Quality Expert •  ISO 13485 Lead Auditor •  GCP Certified
• LL.B & LL.M. in International and EU Law • 10+ years in EU MDR, FDA and quality systems

Who we work with

If your product needs CE marking, a named EU representative, or a regulatory function you do not yet have in-house, you are in the right place.

  • Non-EU manufacturers (US, UK, Canada, Israel, Asia-Pacific) entering the EU market who need an Authorised Representative, Responsible Person or GDPR representative before they can sell.

  • EU MedTech companies, Class I to III, that need a qualified PRRC, audit support or technical documentation help without a full-time hire.

  • Digital health and AI companies whose products face both EU MDR and the EU AI Act — and who need one adviser who understands both.

  • Consumer product brands and marketplace sellers that need a GPSR Responsible Person to keep listings live on Amazon and other EU marketplaces.

 Entering the EU market? One partner for all three mandatory roles.

The EU Market Access Bundle combines your EU Authorised Representative, GPSR Responsible Person and GDPR Article 27 Representative in one annual retainer — one contract, one contact, one set of designation documents.

How an engagement starts

1. Intro call (20 minutes, no charge). You describe your product and where you are in the process. We tell you which obligations apply and whether QLE is the right fit.

2. Written proposal within five working days. Fixed scope, fixed fee, named deliverables, and what is explicitly excluded.

3. Onboarding. Designation letters, document access and a kick-off call. Most representative mandates are live within two weeks.

Why companies choose QLE

Most firms just consult. We step into the actual legal roles—PRRC, Authorized Representative, and DPO. It’s our core business, meaning we take on the regulatory responsibility so you can focus on scale.

We execute this responsibility straight from the source. Situated in the Brussels European Quarter, steps from the European Commission headquarters, we operate where EU regulation is written, keeping your compliance framework perfectly synchronized with the heartbeat of evolving policy.

We back this positioning with absolute transparency. We are not a law firm, a notified body, or a certification authority, and we maintain an honest scope of work—plainly advising you when your path requires a different specialized partner.

Frequently Asked Questions

  • Yes, if you manufacture medical devices or IVDs outside the EU and place them on the EU market — Article 11 EU MDR / IVDR makes an Authorised Representative mandatory. EU-based manufacturers do not need one.

  • Micro and small enterprises under EU MDR/IVDR may use an external PRRC, provided that person is permanently and continuously at their disposal. Larger manufacturers must have the PRRC within their organisation. We advise which applies to you.

  • If you have no establishment in the EU but offer goods or services to, or monitor the behaviour of, people in the EU, Article 27 GDPR generally requires you to appoint an EU representative. Limited exemptions exist for occasional, low-risk processing.

  • It depends on your role (provider, deployer, importer) and your system's risk class. Obligations are phasing in over several years and the timeline has recently been amended — we confirm the current dates that apply to your system during scoping.

  • Representative and PRRC roles are annual retainers; consultancy is fixed-fee per project. After a scoping call we send a written fixed quote. We publish pricing logic on each service page.

  • No. QLE is a regulatory consultancy. We do not issue CE certificates, provide legal representation in court, or replace a notified body's conformity assessment — and we will say so when that is what you need.