Complete support for European pre- and post-market compliance
Strategic regulatory consulting closes the gap between your R&D file and a CE-marked product. Scope: technical documentation per MDR (EU) 2017/745 / IVDR (EU) 2017/746, clinical evaluation per MDCG 2020-13, ISO 14971 risk management, biocompatibility planning per EN ISO 10993, and post-market surveillance. The earlier you engage us, the fewer notified-body deficiencies you fight at submission — most issues we see were inherited from intended-purpose definitions made before regulatory was at the table.
Our regulatory consulting services include
End-to-end coverage from CE conformity through clinical evaluation to post-market surveillance.
CE conformity support
Support during CE conformity assessment procedures according to MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Technical documentation
Preparation of complete technical documentation in line with regulatory requirements.
Risk management file
Preparation of product risk management file according to EN ISO 14971.
Clinical evaluation
Preparation of clinical evaluation for medical devices.
IVD performance evaluation
Regulatory support on performance evaluation for in vitro diagnostics.
Post-market surveillance
Post-market surveillance (PMS) planning and reporting throughout the device lifecycle.
SSCP summary
Summary of safety and clinical performance (SSCP) for higher-risk medical devices.
Gap analysis
Review and gap analysis for technical documentation to identify compliance gaps early.
Biocompatibility
Planning and reporting on biocompatibility activities according to EN ISO 10993-1 ff.
Your questions about regulatory strategy
Strategy from device classification, intended use definition and clinical evaluation planning through MDR / IVDR conformity assessment, notified body selection, technical documentation, and submission preparation. We help you anticipate regulatory hurdles before they delay launch.
The earlier the better — ideally during early R&D when classification, intended purpose and clinical strategy are still being defined. Late-stage engagement is also possible, typically focused on rescuing dossiers or closing notified body deficiencies.
No. MT Promedt is an independent consultancy with no notified body affiliation — our advice is neutral. We work alongside all major notified bodies across the EU.
Yes. Our team supports both medical devices under MDR (EU) 2017/745 and in-vitro diagnostics under IVDR (EU) 2017/746, across all device classes.
Yes. We help prepare pre-submission packages, simulate audits, and accompany clients in NB consultations and audit days.
Once we’ve had a brief intro call and reviewed your device class and intended markets, we can return a fixed-scope or retainer-based proposal within a few business days.
Download our Strategic Consulting brochure
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Strategic Regulatory Consulting — English
Strategic Regulatory Consulting — German
Planning your CE mark or post-market strategy?
Get tailored regulatory consulting and a quote within 24 hours — from gap analysis to clinical evaluation, PMS and SSCP.