Romania Regulatory Process for Medical Devices

1. Initial Concept and Design

Market Research: Conduct thorough market research to identify unmet medical needs, target demographics, and the competitive landscape. Understand the regulatory framework set by ANMDM and the European Union to streamline the development process. Engage with healthcare professionals and stakeholders to validate market demand and refine the device concept.

Risk Management: Perform a risk analysis in accordance with ISO 14971 to identify potential hazards and establish risk control measures. Develop a comprehensive risk management plan to address risks throughout the product lifecycle. Regularly update the risk management file based on findings and improvements.

User Requirements Specification: Define the intended use, user needs, and detailed device specifications. Collaborate with end-users and healthcare professionals to ensure all relevant requirements are captured. Document and prioritise user requirements to guide the design and development process.

Design and Development Planning: Create a detailed project plan outlining timelines, milestones, resources, and budget allocations. Assign responsibilities and establish a project management structure. Schedule regular progress reviews and risk assessments to ensure the project remains on track.

2. Design and Development

Design Inputs: Define functional, performance, and safety requirements based on user needs and regulatory standards. Ensure design inputs are measurable and testable. Document design inputs comprehensively to guide the design process.

Design Process: Develop initial designs and prototypes using CAD software, followed by iterative improvements. Utilise simulation tools and modelling to test design concepts and identify potential issues early. Prepare detailed design documentation, including drawings, specifications, and material lists.

Verification and Validation (V&V): Verification: Ensure that design outputs meet the specified design inputs through rigorous testing and inspection. Conduct bench tests, usability assessments, and software validation as applicable. Document all verification activities and results thoroughly. Validation: Confirm that the final product meets user needs and intended use through clinical evaluations or user trials. Develop and execute validation studies, including clinical trials if necessary. Compile validation results to demonstrate that the device meets its intended purpose.

Design Review: Conduct regular design reviews with cross-functional teams to ensure design compliance and address any issues. Document the outcomes of design reviews and track the implementation of action items. Ensure that design reviews align with regulatory requirements and user needs.

3. Regulatory Strategy

Classification: Determine the appropriate classification of the device based on its intended use and risk level (Class I, IIa, IIb, or III). Follow the European Union’s classification rules outlined in the MDR to determine the classification.

Regulatory Pathway: Define the regulatory pathway for approval, considering requirements from ANMDM and European Union regulations. Develop a regulatory submission plan detailing the necessary documentation and timelines. Stay updated on regulatory changes and guidelines issued by ANMDM and the European Union.

Quality Management System (QMS): Implement a QMS compliant with ISO 13485 to manage quality throughout the product lifecycle. Develop and document procedures for design control, risk management, supplier management, and post-market surveillance. Conduct regular internal audits to ensure compliance with QMS requirements.

4. Pre-Clinical Testing

Bench Testing: Perform mechanical, electrical, and software testing to verify device performance and safety. Develop test protocols and acceptance criteria based on design inputs. Document all testing activities and results in a comprehensive test report.

Biocompatibility Testing: For devices in contact with the body, conduct biocompatibility tests in accordance with ISO 10993 standards. Identify the specific tests required based on the device’s materials and intended use. Compile biocompatibility test reports to demonstrate regulatory compliance.

Animal Studies: If necessary, conduct pre-clinical studies on animals to assess safety and efficacy before human trials. Obtain ethical approval for animal studies and adhere to relevant guidelines. Analyse and document results to support regulatory submissions.

5. Clinical Evaluation

Clinical Investigation Plan: Develop a detailed plan outlining study objectives, methodology, and endpoints. Define inclusion and exclusion criteria, sample size, and statistical methods. Ensure the clinical investigation plan aligns with regulatory requirements and ethical standards.

Ethics Approval: Obtain approval from an Institutional Review Board (IRB) or ethics committee for clinical trials. Prepare and submit necessary documentation, including the clinical investigation plan, informed consent forms, and investigator brochures.

Clinical Trials: Conduct trials to gather clinical data on safety and performance. Recruit and train investigators, monitor study sites, and ensure adherence to the clinical investigation plan. Collect and analyse clinical data, addressing any adverse events or protocol deviations.

Clinical Evaluation Report (CER): Compile and analyse clinical data to demonstrate compliance with regulatory requirements. Summarise findings related to safety and performance. Ensure the CER is thorough and meets all relevant regulatory criteria.

6. Conformity Assessment and Submission

Technical Documentation: Prepare detailed documentation, including: Design dossier, Risk management file, Verification and validation reports, Clinical evaluation report, Labelling and Instructions for Use (IFU).

ANMDM Submission: Submit the necessary documentation to ANMDM based on the device classification: Class I: Generally exempt from detailed premarket submission but still requires basic compliance. Class IIa, IIb, and III: Submit a comprehensive Medical Device Licence application including clinical data and safety information.

7. ANMDM Review and Approval

Review Process: ANMDM reviews the submission for completeness, scientific validity, and regulatory compliance. Prepare to respond to queries and provide additional information during the review process.

Interactive Review: Engage with ANMDM throughout the review process to address questions and provide necessary information. Maintain open communication to facilitate a smooth review process.

Approval/Authorisation: Upon successful review, ANMDM grants market authorisation. Receive official documentation confirming the device’s approval for market entry in Romania.

8. Manufacturing

Production Planning: Develop a comprehensive manufacturing plan, including material procurement, production schedules, and resource allocation. Identify and qualify suppliers to ensure they meet quality and regulatory standards.

Process Validation: Validate manufacturing processes to ensure consistent product quality. Perform process qualification and validation studies, and document results in a process validation report.

Quality Control: Implement rigorous quality control measures to monitor and maintain product quality. Establish quality control procedures and conduct regular inspections and tests.

Packaging and Labelling: Ensure packaging and labelling comply with regulatory requirements and provide clear information to users. Design packaging to protect the device during transport and storage. Develop labelling that includes instructions for use, warnings, and other necessary information.

9. Post-Market Surveillance

Post-Market Surveillance Plan: Develop a plan to monitor device performance and safety after market release. Define procedures for collecting and analysing post-market data, including user feedback and adverse event reports.

Vigilance Reporting: Report adverse incidents and safety concerns to ANMDM as required. Implement a system for tracking and managing vigilance reports.

Periodic Safety Update Reports (PSURs): For higher-risk devices, submit regular safety updates to ANMDM. Include data on device performance, adverse events, and corrective actions taken.

Customer Feedback: Collect and analyse feedback from users to identify areas for improvement. Implement a system for managing customer complaints and addressing product issues.

10. Continuous Improvement

CAPA System: Implement a Corrective and Preventive Action (CAPA) system to address quality issues and prevent recurrence. Investigate root causes of issues, develop corrective actions, and verify their effectiveness.

Internal Audits: Conduct regular internal audits to ensure ongoing compliance with regulatory requirements and QMS. Document audit findings and track the implementation of corrective actions.

Training and Development: Provide continuous training for employees to keep them updated on regulatory changes and industry best practices. Develop training programmes focused on quality management, regulatory compliance, and technical skills.

R&D and Innovation: Invest in research and development to drive innovation and improve existing products. Foster a culture of continuous improvement and innovation within the organisation.

Conclusion The process of developing and bringing a medical device to market in Romania involves a structured and highly regulated pathway to ensure products meet rigorous standards of safety, efficacy, and quality. From the initial concept through to post-market surveillance, each stage requires meticulous planning, thorough testing, and ongoing monitoring. By adhering to regulatory requirements and maintaining a robust quality management system, manufacturers can effectively navigate the complexities of the medical device landscape, ensuring their products deliver significant benefits to patients and healthcare providers.