EU MDR Consultants – Expert Support for Full Compliance

EU MDR Consultants are specialized professionals who guide medical device manufacturers—including those producing equipment, single-use devices, software, implants, reusable tools, active/non-active devices, and hospital consumables—through the complex landscape of EU MDR 2017/745.

What is EU MDR 2017/745?

The European Medical Device Regulation (EU MDR), adopted in April 2017 and fully enforced from May 26, 2021, replaces the older Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). It introduces a more robust regulatory framework aimed at strengthening patient safety, device performance, and market transparency.

Core Elements of EU MDR Compliance:

Device Classification
Conformity Assessment Procedures
Post-Market Surveillance (PMS)
Unique Device Identification (UDI)
Clinical Evidence Requirements
Involvement of Notified Bodies
Supply Chain Traceability

Compliance is mandatory for all medical devices placed on the EU market—whether imported or locally manufactured. Non-compliance can lead to port entry rejection, certificate suspension, market withdrawal, or product recalls.

The Role of EU MDR Consultants – Regulation 2017/745

EU MDR Consultants play a vital role in supporting medical device manufacturers, importers, and distributors to ensure full compliance with the Medical Device Regulation (MDR) 2017/745. These experts provide tailored guidance across every stage of the regulatory process—from classification and documentation to clinical evaluation and Notified Body engagement.

Key Areas Where EU MDR Consultants Add Value:

Regulatory Strategy Development
Determine device classification, applicable conformity routes, and standards aligned with MDR 2017/745.
Technical Documentation Preparation
Draft and review all elements of the technical file as per Annex II, ensuring clarity, accuracy, and compliance.
Quality Management System (QMS) Support
Assist in setting up or refining a QMS that meets MDR requirements, including design control, risk management, and post-market procedures.
Clinical Evaluation Support
Plan, collect, and evaluate clinical evidence in accordance with Article 61 and applicable MEDDEV guidance for CER development.
Post-Market Surveillance (PMS)
Establish robust PMS systems, including vigilance reporting, trend analysis, and development of PSURs.
Notified Body Interaction
Prepare and manage CE marking submissions, respond to queries, address review comments, and participate in audits and inspections.

At RAPS, our consultants operate in ISO 13485 and ISO 27001 certified environments, ensuring top-tier quality assurance and data security. Our team commits to prompt, expert communication—responding to all technical queries within 24 hours.

Who Should Use EU MDR Consulting Services?

Any organization involved in developing, manufacturing, or distributing medical devices intended for CE marking or EU market access can benefit from our consulting services. This includes: