Medical Devices
MDR (EU) 2017/745
Comprehensive regulatory support for Class I to Class III medical devices — from CE conformity assessment to post-market surveillance.
Our company
Independent regulatory consulting since 1995
We represent medical device and IVD manufacturers in front of European and UK authorities — from start-ups closing their first CE mark to international groups consolidating regulatory representation across markets. From our headquarters in St. Ingbert, Saarland, plus offices in Oxford and Salt Lake City, we cover EU and UK market access under one mandate.
Our scope spans the regulatory lifecycle: technical documentation, conformity assessment, MDR / IVDR submissions, QMS implementation to EN ISO 13485, vigilance and post-market surveillance. We act as European Authorised Representative under MDR (EU) 2017/745 and IVDR (EU) 2017/746, and as UK Responsible Person from our Oxford office — one engagement, two markets. Every project is led by a senior consultant who stays on the file from kick-off to audit.
Industries we serve
Regulatory expertise across healthcare
In Vitro Diagnostics
IVDR (EU) 2017/746
Specialised consulting for IVD manufacturers navigating IVDR classification and compliance pathways for the European market.
Pharmaceutical & Biotech
Strategy & QMS
Regulatory strategy and quality management support for pharmaceutical and biotechnical industry partners worldwide.
EN ISO 13485:2016 — TÜV Rheinland Cert. SX 1546485-1
EUDAMED Registered SRN: DE-AR-000000085
How we work
Your path to market access
01
Discovery
Initial assessment of your devices, target markets and current compliance status.
02
Strategy
Regulatory roadmap with prioritised milestones across MDR / IVDR and target jurisdictions.
03
Implementation
Documentation, QMS, conformity assessment and submission support — hands-on with notified bodies and competent authorities.
04
Post-market
Surveillance, vigilance reporting and ongoing compliance once your device is on the market.
Our team & expertise
Interdisciplinary expertise across the device lifecycle
Our team combines pharmacists, microbiologists, chemists and biomedical engineers — backgrounds that match what notified bodies and competent authorities expect at the technical-review table. The same senior consultants you brief at kick-off remain on the file through audits and post-market vigilance.
Quality Management Systems
Implementation and maintenance of QMS aligned with EN ISO 13485, MDSAP and applicable regional schemes.
International Regulatory Requirements
EU MDR / IVDR, UK MHRA, FDA, ANVISA, NMPA and more — one team, one strategy across markets.
CE Conformity Assessment & Product Safety
Conformity assessment procedures, product safety assessment and testing — structured, audit-ready documentation.
Production Validation & Post-Market Surveillance
Planning and performance of production processes, product validation and post-market surveillance activities.
Clinical Trials & Investigations
Knowledge across clinical trial planning and performance — study design, sponsor support, documentation and reporting.
Where we operate
Local presence where regulators sit. Global coverage where you sell
Each of our offices was opened to be on the ground next to a key regulator — the EU institutions in Germany, the FDA in the United States, and the MHRA in the United Kingdom. Together they let us cover every major Western market under one contract.
Germany · Headquarters
St. Ingbert
EU Authorised Representative since 1995
Ernst-Heckel-Straße 7
66386 St. Ingbert, Germany
- +49 6894 581020
- +49 6894 581021
- info@mt-procons.com
USA · Liaison office
Salt Lake City
FDA-related projects & US agent services
41 North Rio Grande Street, #100
Salt Lake City, Utah 84101, USA
UK · UK Responsible Person
Oxford
UK RP services since January 2021
First Floor, Park Central
40-41 Park End Street
Oxford, OX1 1JD, United Kingdom
FAQ
Frequently asked questions
Class I self-certification typically completes in weeks once your technical documentation is in shape. Class IIa, IIb and III require a notified body and run from several months to over a year — driven mainly by notified-body capacity, not the file itself. We assess your documentation in the first call and give you a realistic milestone plan instead of a generic range.
Yes. We serve as European Authorised Representative from our German office and UK Responsible Person from our Oxford office, covering EU and UK market access through one mandate.
Yes. PMS and vigilance reporting are part of the standard Authorised Representative mandate. We log incident reports, prepare trend analyses and act as your liaison to the competent authorities throughout the full lifecycle of your device.
Through our local-partner network we support market access in 12 jurisdictions worldwide — including USA, Canada, Brazil, Israel, Saudi Arabia, China, Korea, Japan, Singapore, Malaysia and Australia.
Three profiles dominate our book: MedTech start-ups closing their first CE mark, established international groups (USA, Japan, Korea, Israel) consolidating EU and UK representation, and DACH Mittelstand manufacturers expanding into Asia or the Americas. We cover all device classes — MDR Class I–III and IVDR Class A–D — and engage selectively on pharmaceutical and biotech regulatory strategy.
Send a short brief: your devices, your target markets and the deadline you’re working against. A senior consultant takes the first call and follows up with a scoped next-step proposal — not a generic intro deck.
Ready to access European markets?
Tell us about your devices, target markets and the deadline you’re working against — we come back with a scoped next step, not a generic proposal.