MDR & IVDR · Regulations (EU) 2017/745 and 746

Your EU Authorised Representative for medical devices.

For manufacturers based outside the EU: we review your technical documentation, help you bring it in line with the MDR or IVDR and represent you on the European market.

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  • from €6,000onboarding, first year included
  • Since 2011regulatory experience

Registered in EUDAMED as Authorised Representative · SRN IT-AR-000060962

Process

Three steps from first contact to the EU market.

Onboarding brings your documentation in line, once. Then you sign the mandate and mdrep.eu takes on the role of Authorised Representative, year after year.

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Onboarding

  1. Step 01

    Documentation review

    You
    Send us your technical documentation, EU declaration of conformity, certificates and labels.
    We
    Review it against Regulation (EU) 2017/745 or 746 (MDR or IVDR), including the conformity assessment route.
  2. Step 02

    Changes and corrections

    We
    List the necessary changes, including the addition of mdrep.eu as Authorised Representative on labels, instructions for use and declaration of conformity.
    You
    Implement them: we check that every point has been closed.

Mandate

  1. Step 03

    Mandate and representation

    You
    Sign the mandate, complete your manufacturer and device registrations and keep us informed of any changes.
    We
    Formally accept the mandate, register in EUDAMED as your Authorised Representative and represent you year after year: documentation available to the authorities, cooperation on corrective actions, complaints forwarded to you immediately.
Pricing

Clear fees for your EU representation, set out in the mandate.

A one-off onboarding fee that already covers your first year, then an annual fee to keep us as your Authorised Representative.

Module 1

Onboarding

from€6,000one-off

Includes your first year as EU Authorised Representative

What's included

  • Review of your technical documentation against Regulation (EU) 2017/745 or 746 (MDR or IVDR)
  • List of the changes needed to include mdrep.eu as Authorised Representative in your documentation and quality system
  • Verification that any non-conformities have been closed
  • Formal acceptance of the mandate and our registration in EUDAMED as your Authorised Representative
  • First year of appointment as your EU Authorised Representative
Module 2

Mandate

from€5,000per year

From the second year, renewed annually

What's included

  • Appointment as your EU Authorised Representative
  • Technical documentation and EU declaration of conformity kept available to the competent authorities
  • Cooperation with the authorities on any preventive or corrective action
  • Complaints and incident reports forwarded to you immediately
  • Verification of your UDI and registration obligations
  • An up-to-date archive of your device documentation

Beyond routine duties. Activities such as incidents and vigilance cases, extraordinary complaints, device modifications, technical documentation updates, audits by a competent authority are billed separately at the hourly rate set out in the mandate. All fees are exclusive of VAT.

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About us

Regulatory experts, not just a European address.

mdrep.eu is an EU Authorised Representative built on the regulatory team of Sistemir, which has been managing CE marking for medical devices of all classes since 2011, both active and non-active: electro-medical devices, software, implantable devices, surgical instruments and medical gas systems.

That expertise is what makes the difference. Before accepting the mandate, we analyse your documentation in depth and tell you exactly what needs to be added. Gaps are closed before your device reaches the market, not when an authority finds them. And when a competent authority gets in touch, we already know your file and can respond promptly and precisely.

2011Regulatory experience since
OneDedicated point of contact
AllDevice classes
Frequently asked questions

What manufacturers ask before appointing us.

Typically: evidence of conformity with the general safety and performance requirements (Annex I of the MDR or IVDR), risk management documentation, clinical or performance evaluation, the technical file index, master labels and labelling processes, the Notified Body certificate where required, the EU declaration of conformity and, where applicable, the complaints and reports to the authorities of the last three years. We also need your company and PRRC details, your ISO 13485 certificate if available and your product liability insurance details.

Because our name will appear on your device, we accept the mandate only after verifying that the EU declaration of conformity has been drawn up and that the appropriate conformity assessment procedure has been carried out. Any necessary corrections are sent to you in writing; once they have been closed, we formally accept the mandate and register in EUDAMED as your Authorised Representative.

The name and address of mdrep.eu as Authorised Representative must be added to the labelling, the instructions for use and the EU declaration of conformity, as well as to the relevant documents of your quality management system. During onboarding we tell you exactly what to change. If the mandate ends, our details must be removed.

Yes. Under the MDR and IVDR, the Authorised Representative can be held jointly and severally liable with the manufacturer for defective devices. The mandate therefore requires product liability insurance proportionate to the risk class, the type of device and the size of your company, extended to cover mdrep.eu as your Authorised Representative.

Onboarding (from €6,000, one-off) covers the documentation review, the list of changes, the check that non-conformities have been closed and your first year of appointment. From the second year, the annual fee (from €5,000) covers the appointment and the routine duties of the Authorised Representative. Non-routine activities, such as incidents and vigilance cases, extraordinary complaints, device modifications, technical documentation updates, audits by a competent authority, are billed at the hourly rate set out in the mandate. Any fees charged by authorities, Notified Bodies or other third parties are borne by the manufacturer. All fees are exclusive of VAT.

The mandate lasts one year and renews automatically. From the end of the second year, either party can terminate it with written notice at least 90 days before the end of the annual term. Some obligations continue after the mandate ends, such as forwarding complaints and incident reports for up to ten years; these are covered by a fixed fee set out in the agreement.

Contact

Start with a tailored quote for your device.

Tell us what your device is and where its documentation stands. The quote is free and without obligation.

  1. We get back to you to understand your device and its documentation.
  2. You receive a quote with the onboarding and annual fees for your device.
  3. Onboarding starts with the review of your documentation.
contact@mdrep.euVia Roma, 28 – 23900 Lecco, Italy
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