Expert Regulatory Consulting

Europe

• EU MDD to EU MDR Transition Support

The transition from EU MDD (Medical Device Directive) to EU MDR (Medical Device Regulation) is a critical step for medical device manufacturers to ensure continued market access in Europe. At Medoctra, we simplify this transition process by providing comprehensive support tailored to your unique needs. Our expertise ensures your documentation, processes, and compliance frameworks align seamlessly with the MDR requirements for CE Certification.

How Medoctra Helps:

Gap Analysis (MDD to MDR): We assess the gaps in your current compliance, helping you identify areas that need improvement to meet MDR standards.

• STED Preparation: Our team assists in creating the Summary of Technical Documentation, ensuring it adheres to MDR guidelines for regulatory submissions.

• Clinical Evaluation Support: Medoctra develops and updates Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), conducting in-depth literature reviews and gap assessments.

• PMS Updates: We provide support in updating Post-Market Surveillance (PMS) documents, including PMS Plans, Post-Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-Up (PMCF) Plans.

With Medoctra, your transition to MDR becomes a structured and efficient process, ensuring compliance while minimizing risks and delays.

• EU MDR 2017/745 Compliance

The EU MDR Medical Device Regulation 2017/745 EU was published in 2017 as a comprehensive revision of previous Medical Device Directive 93/42/EEC. It is important that the Medical Device must comply according to the EU MDR 2017/745.

Medoctra create a compliance plan that defines the strategy and steps to comply with regulatory requirements, it includes project plan, execution and ensures the structured implementation of the plan to get CE certificate.

How Medoctra Helps:

List of Applicable Standards:

We identify list of applicable standards to Medical Device to meet State of Art.

Post Market Surveillance Activity:

PMCF Survey Execution for EU MDR Compliance

Post-Market Clinical Follow-Up (PMCF) is a critical requirement under EU MDR, demanding manufacturers generate real-world clinical evidence to confirm device safety and performance. Medoctra specializes in designing and executing high-quality PMCF surveys that meet EU regulatory expectations and GDPR compliance.

How Medoctra Helps:

• PMCF Plan Development: We create comprehensive PMCF plans, including statistical analysis frameworks, tailored to the specific needs of your medical device.

• Survey Design and Data Collection: Medoctra designs effective surveys aligned with EU-approved methodologies and GDPR-compliant data protection protocols.

• High-Quality Data Management: Our team ensures accurate and robust data collection through validated tools to generate reliable clinical evidence.

• Statistical Analysis and Reporting: We analyze the collected data and prepare PMCF Survey Reports and Evaluation Reports, ready for submission to notified bodies.

• NB Liaison: Medoctra acts as your liaison with notified bodies, ensuring effective communication and addressing feedback efficiently.

With Medoctra’s expertise, you can confidently generate and submit PMCF data to demonstrate compliance and maintain market approvals for your devices.

PMS Strategy and Support

Post-Market Surveillance (PMS) is a cornerstone of medical device compliance under EU MDR, requiring proactive monitoring of devices throughout their lifecycle. At Medoctra, we provide strategic PMS support to help you collect, analyze, and act on post-market data efficiently.

How Medoctra Helps:

• Complaint Handling & Adverse Event Reporting: We streamline systems to manage complaint handling and report adverse events promptly to regulators.

• PMSR and PSUR Development: Medoctra prepares detailed Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) to meet MDR requirements.

• PMCF Plan and Reporting: Our team develops and implements PMCF plans, ensuring ongoing clinical follow-up to monitor long-term device performance.

• PMS Surveys: We execute PMS surveys to gather real-world feedback and clinical data, strengthening your post-market strategy.

Medoctra’s PMS support services ensure you stay proactive, compliant, and responsive to evolving regulatory requirements, safeguarding patient safety and device quality.

Clinical Evaluation- Strategy and Support

Robust clinical strategies are essential for demonstrating device safety, efficacy, and performance. At Medoctra, we help you design and implement clinical strategies that meet global regulatory standards.

How Medoctra Helps:

• Clinical Strategy Consulting: We create clinical roadmaps tailored to your device and market needs.

• CIP and IB Preparation: Our team develops Clinical Investigation Plans (CIP) and Investigator Brochures (IB) to ensure smooth clinical trials.

• Literature Reviews: Medoctra conducts comprehensive literature reviews to strengthen your clinical evaluations.

• Clinical Writing: We prepare Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Summary of Safety and Clinical Performance (SSCP) documents.

• Risk-Benefit Analysis: Our team provides clinical risk-benefit analysis to demonstrate safety and performance.

• Promotional Material Reviews: Medoctra ensures all promotional claims align with clinical evidence and regulatory requirements.

With Medoctra as your partner, you can establish strong clinical foundations that drive regulatory success and market approval.

Risk Management:

Medical device risk management is the process of identifying, assessing, and mitigating risks associated with medical devices. Medoctra prepare Risk Management Plan, Risk Management Report as per requirements of ISO 14971,

GSPR:

General Safety and Performance Requirements (GSPR) are set out requirements for the safe and effective design, manufacture, and use of Medical Devices. Medoctra provide guidance and support how to fulfill requirements and preparation of GSPR.

STED Preparation:

Our team assists in creating the Summary of Technical Documentation, ensuring it adheres to EU MDR guidelines for regulatory submissions.

• EUDAMED Registration

As a part of EU MDR 2017/745 compliance Medical Device Manufacturer needs to do EUDAMED registration to generate SRN (Single Registration Number). Medoctra support for EUDAMED registration and fulfil PRRC requirements.

• Drug Device Combination Products

Article 117 of EU MDR 2017/745 is talking about conformity of device constituent part with relevant General Safety and Performance Requirements. Medoctra provides roadmap to fulfill requirements Annexure I, compile complete technical package and get Notified Body Opinion Report.

QMS

• QMS Strategy and Support

A strong Quality Management System (QMS) is vital for maintaining regulatory compliance and ensuring product quality. Medoctra provides expert QMS support to align your processes with EU MDR and ISO 13485 requirements.

How Medoctra Helps:

• SOPs, Work Instructions, and Templates: We create and optimize procedures, SOPs, and templates tailored to your organization’s needs.

• QMS Transformation: Medoctra supports full-scale QMS transformation to meet EU MDR compliance.

• Product Risk Management: We provide risk management plans, risk evaluation files, and associated documentation to ensure product safety.

Medoctra’s QMS support streamlines your processes, ensuring compliance, operational excellence, and a strong foundation for global market success.

CDSCO India Regulatory

o Import License: CDCO published list of Medical Devices, importer needs to take import license before importing of the Medical Device/In-Vitro Diagnostic Device in India. Medoctra provides complete solution to get import license by preparing Device Master File, Plant Master File and application support.

o Manufacturing/Loan License: Indian Manufacturer needs to get manufacturing/Loan license (Form MD-3 and MD -4, MD-7, MD-8) before manufacturing of Medical Devices. Medoctra prepare complete technical package in formats provided by CDSCO. (Device Master File, Plant Master File etc)

o Test License: To perform testing on Medical Device needs to procure Test License. Medoctra prepare Test Licence package in prescribed format of CDSC.

Trainings

o ISO 13485 : Medoctra provides training on ISO 13485 to understand requirements, simplify writing of Quality Manual and SOP, audit requirements.

o EU MDR 2017/745: As EU MDR come up with multiple requirements and manufacturer needs to understand requirements before fulfilling it. Medoctra simplify the understanding.

o CDSCO: This is a new regulatory requirement framework given by CDSCO, Medoctra provides trainings to understand and implement requirements.

Medoctra's expertise in regulatory consulting streamlined our market approval process, ensuring compliance across regions. Their strategic approach made a complex journey manageable and efficient.

John Doe

★★★★★