EU MDR Regulatory Services

Bringing a medical device to market in Europe requires compliance with the EU Medical Device Regulation (EU MDR 2017/745). The European Union (EU) has some of the strictest medical device regulations in the world, emphasizing patient safety, clinical performance, and post-market surveillance.

At iMDR MedTech, we provide comprehensive regulatory consulting services to help medical device manufacturers, importers, and distributors achieve EU MDR compliance and obtain CE Marking. With 200+ global regulatory experts, we guide companies through every stage of the EU MDR conformity assessment process, ensuring smooth market entry and ongoing compliance.

What is the EU MDR (2017/745)?

The European Medical Device Regulation (MDR 2017/745) replaces the previous Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC). The EU MDR introduces stricter regulatory requirements, including:

✅ More stringent clinical evidence requirements for medical devices.
✅ Expanded scope to cover additional devices (e.g., software as a medical device).
✅ Reclassification of certain devices with new risk-based rules.
✅ Enhanced post-market surveillance (PMS) and vigilance reporting.
✅ Unique Device Identification (UDI) system for traceability.
✅ Stronger requirements for technical documentation and QMS compliance.

Failure to comply with EU MDR can result in regulatory penalties, market withdrawal, or loss of CE Marking.

Our EU MDR Regulatory Services

We provide end-to-end regulatory support to ensure your medical device meets all EU MDR requirements and successfully achieves CE Marking.

✅ EU MDR Classification & Regulatory Strategy

Determining the correct classification is the first step in regulatory compliance. Our experts:

• Identify the risk class (Class I, IIa, IIb, III) under EU MDR Annex VIII.

• Develop a regulatory roadmap for the CE Marking process.

• Define the applicable conformity assessment routes with a Notified Body.

• Assess the impact of EU MDR transition timelines on your device portfolio.

✅ Technical Documentation & CE Marking Support

The EU MDR requires extensive technical documentation (Annex II & III) for CE Marking. We assist in:

• Preparing comprehensive technical files per Notified Body expectations.

• Developing Device Master Files (DMF) and Clinical Evaluation Reports (CERs).

• Ensuring compliance with General Safety and Performance Requirements (GSPR).

• Conducting gap assessments to align legacy devices with MDR requirements.

✅ Clinical Evaluation (EU MDR Annex XIV) & Clinical Trials

Clinical evidence is a critical component of EU MDR compliance. We provide:

• Clinical Evaluation Reports (CERs) per MDCG 2020-13 guidance.

• Post-market clinical follow-up (PMCF) plans and reports.

• Clinical investigation design and regulatory submissions.

• Alignment with ISO 14155 (Good Clinical Practices for medical devices).

✅ Quality Management System (QMS) Compliance – ISO 13485 & EU MDR

EU MDR requires manufacturers to implement a robust Quality Management System (QMS). Our QMS services include:

• Establishing ISO 13485:2016-compliant QMS.

• Aligning QMS processes with EU MDR Article 10 requirements.

• Preparing for Notified Body audits and MDR certification.

• Implementing risk-based approaches per ISO 14971 (Risk Management for Medical Devices).

✅ Notified Body Selection & Audit Preparation

Notified Bodies (NBs) play a critical role in CE Marking certification. We assist with:

• Identifying and liaising with EU MDR-designated Notified Bodies.

• Preparing manufacturers for NB audits and assessments.

• Addressing Notified Body nonconformities and CAPA responses.

✅ Post-Market Surveillance (PMS) & Vigilance Reporting

EU MDR strengthens post-market requirements, making PMS & vigilance crucial. Our services include:

• Developing PMS plans and reports in compliance with MDR Annex III.

• Establishing Post-Market Clinical Follow-up (PMCF) procedures.

• Implementing Medical Device Reporting (MDR) and vigilance systems.

• Assisting with Field Safety Corrective Actions (FSCA) and recalls.

✅ Unique Device Identification (UDI) Compliance

The EU UDI system enhances device traceability. We support:

• UDI-DI and UDI-PI assignment as per MDR requirements.

• Registration in EUDAMED (European Database on Medical Devices).

• Ensuring compliance with GS1, HIBC, and ICCBBA standards.

✅ Economic Operators Compliance (Importers, Distributors, PRRC)

EU MDR imposes new obligations on Economic Operators (manufacturers, importers, distributors, PRRC). We help:

• Appointing an Authorized Representative (EC REP) in Europe.

• Ensuring PRRC (Person Responsible for Regulatory Compliance) compliance.

• Conducting supplier audits and agreements with importers/distributors.

Why Choose iMDR MedTech for EU MDR Compliance?

✔ 200+ Regulatory Experts Worldwide – Decades of experience in CE Marking, Notified Body interactions, and QMS compliance.
✔ Comprehensive MDR Consulting – From classification to post-market compliance, we cover every aspect.
✔ Fast-Track Market Entry – We help you avoid delays and achieve smooth EU certification.
✔ Global Reach – Support for multinational manufacturers entering the EU medical device market.
✔ Customized Solutions – Tailored strategies for startups, SMEs, and large MedTech enterprises.

Get Your Medical Device EU MDR-Compliant with iMDR MedTech

Achieving EU MDR compliance is challenging, but with iMDR MedTech, you get expert guidance every step of the way. Whether you're seeking CE Marking for a new device, transitioning from MDD to MDR, or managing post-market obligations, we can help!

📩 Contact us today at info@imdrmedtech.com for expert assistance with EU MDR regulatory compliance!