Three decades of regulatory work behind your CE mark
MT Promedt Consulting has acted as European Authorised Representative under MDR (EU) 2017/745 and IVDR (EU) 2017/746 since 1995 — through MDD, MDR, IVDR, UKCA and Brexit. EN ISO 13485:2016 certified. EUDAMED-registered with SRN.
Selling medical devices into the EU from outside Europe? Under MDR Article 11, you need an EU Authorised Representative. We have represented manufacturers from the United States, China, Japan, Korea, Israel, Brazil and beyond.
Headquartered in St. Ingbert (Germany), with offices in Oxford (UK Responsible Person since 2021) and Salt Lake City (USA) — one contract, one English-speaking team, one EUDAMED SRN.
Learn moreDesignated EU representation under MDR (EU) 2017/745 and IVDR (EU) 2017/746. Full EUDAMED registration with SRN. Continuous EAR service since 1995.
- EUDAMED SRN
- Vigilance reporting
- Post-market surveillance
MHRA registration and UKCA marking from our Oxford office. Continuous UK Responsible Person service since January 2021.
- MHRA registration
- UKCA marking
- Oxford office (since 2021)
CE conformity, technical documentation, clinical evaluation per MDCG 2020-13 and ISO 14971 risk management — strategic and hands-on.
- CE conformity
- Clinical evaluation
- ISO 14971 risk management
Implement and maintain QMS per EN ISO 13485:2016. CAPA processes, internal audits and notified-body audit preparation.
- EN ISO 13485:2016
- CAPA processes
- Notified-body audit prep
Market access in twelve jurisdictions worldwide — one contract, local experts who know FDA, ANVISA, NMPA, PMDA, MFDS and TGA submissions.
- 12 jurisdictions worldwide
- FDA · ANVISA · NMPA
- PMDA · MFDS · TGA
Practice-oriented in-house and seminar trainings on MDR, IVDR, ISO 14971, PRRC duties and biocompatibility per ISO 10993-1.
- MDR / IVDR
- ISO 14971 + PRRC
- Biocompatibility (ISO 10993-1)
From classification to post-market
One regulatory partner, three decades of experience: every stage from device classification to vigilance reporting under MDR, IVDR and UKCA.
Strategy & Classification
We classify your device, map the regulatory pathway — MDR, IVDR, UKCA, or international — and run a gap analysis of your existing technical documentation.
Regulatory roadmap and gap report after the initial assessment.
Submission & Authorisation
We prepare your technical file, manage notified-body interaction, and act as your Authorised Representative across the EU, UK, and Switzerland.
Submission-ready technical file — we handle auditor queries on your behalf.
Vigilance & Ongoing Compliance
Post-market surveillance, vigilance reporting, EUDAMED maintenance, and liaison with competent authorities — so your CE mark stays valid year after year.
Continuous EAR service since 1995 — no service gaps.
Twelve jurisdictions. One regulatory partner.
Markets by region
DE
EU
UK
US
CA
CN
JP
KR
SG
SA
AE
IL
BR
AU
Local partners in 12 jurisdictions
What manufacturers ask about EU representation
A European Authorised Representative (EAR) is the legally mandated EU contact for non-EU manufacturers of medical devices and in vitro diagnostics. Under MDR (EU) 2017/745 Article 11 and IVDR (EU) 2017/746 Article 11, every non-EU manufacturer placing devices on the EU market must designate one EAR who registers with EUDAMED, receives a Single Registration Number (SRN), and represents the manufacturer before competent authorities.
Any manufacturer headquartered outside the European Union that wants to place medical devices or IVDs on the EU market must appoint a European Authorised Representative before CE marking. The EAR designation has been mandatory since the MDD/IVDD era and is reinforced under MDR (EU) 2017/745 and IVDR (EU) 2017/746 — without an EAR your products cannot enter the EU legally.
EUDAMED is the European Database on Medical Devices operated by the European Commission. Every manufacturer, EAR and importer must complete EUDAMED registration and receive a Single Registration Number (SRN), which appears on the Declaration of Conformity, on instructions for use and on EU device labels. MT Promedt Consulting handles the full EUDAMED registration process and maintains your SRN over time.
MDR (EU) 2017/745 governs medical devices — from Class I bandages to Class III implants — while IVDR (EU) 2017/746 governs in vitro diagnostics such as laboratory tests, self-tests and companion diagnostics. Both regulations require an Authorised Representative for non-EU manufacturers, but classification rules, clinical evidence requirements and notified body involvement differ. MT Promedt provides EAR services under both regulations.
Yes. MT Promedt Consulting offers EU Authorised Representative services from Germany (EUDAMED SRN holder) and UK Responsible Person services from our Oxford office, registered with the MHRA. One contract covers both regulatory frameworks, ensuring continuous compliance for the EU and the post-Brexit UK market in a single workflow.
MT Promedt Consulting has acted as a European Authorised Representative continuously since 1995 — throughout the entire transition from the MDD/IVDD framework to MDR (EU) 2017/745 and IVDR (EU) 2017/746. Three decades of regulatory practice mean no service gaps, no outsourcing of representation, and direct accountability before competent authorities and notified bodies.
Through twelve regional partners under a single contract, MT Promedt supports market access in the EU, UK, Switzerland, USA (FDA), Brazil (ANVISA), China (NMPA), Japan (PMDA), South Korea (MFDS), Australia (TGA), Canada (Health Canada), the GCC region and several ASEAN markets. We coordinate product registration, local representation and post-market reporting across all twelve jurisdictions.
Ready to bring your device to market?
30-minute regulatory pathway assessment. No commitment, NDA on request.
- EN ISO 13485:2016 certified consultancy
- Active EUDAMED SRN since 1995
- Response within one business day
- Direct contact with senior regulatory consultants