The 2017/746 Regulation (IVDR) came into effect on May 25, 2017, replacing Directive 98/79/EC (IVDD) on EU medical devices. It introduces several changes as well as new rules for CE marking authorization. Our article explores the administrative constraints related to this new regulation and the organizational implications for the in vitro diagnostic medical device (IVD) industry.
Understanding the 2017/746 Regulation
The IVDR aims to ensure better safety for patients and public health, as well as optimal efficiency for medical devices marketed in the European Union. The key modifications introduced by this new regulation are:
- Strengthening performance and safety requirements;
- Revising the classification of devices;
- Improving traceability;
- Enhancing post-market surveillance;
- Increasing transparency and improving information communication;
- Extending to laboratories (certain personalized diagnostic devices or those used solely in health laboratories are now regulated under IVDR).
The administrative challenges of the new EU regulation for IVDs
Providing detailed documentation
The IVDR requires comprehensive documentation for each device, including product descriptions, performance specifications, and proof of safety and effectiveness.
Risk management
Risk management is a central element of the IVDR. Companies must implement a comprehensive control system compliant with European standards. This necessitates reevaluating and updating existing procedures.
Closely monitoring post-market activities
Rigorous procedures, included in the PMS (Post-Market Surveillance) system, must ensure continuous monitoring of devices after they are placed on the market. These include the collection and analysis of performance data and incidents:
- Information on all non-serious incidents and data provided by all stakeholders (users, distributors, and importers), as well as adverse side effects;
- Serious incidents and Field Safety Corrective Actions (FSCA);
- Specialized and technical documentation, including databases and registers.
For Class C and D devices, manufacturers must submit Periodic Safety Update Reports (PSURs) to the notified body. These allow continuous risk and benefit evaluations of the devices after market introduction. The PSUR must be updated annually and made available in Eudamed.
Ensuring optimal traceability
The implementation of the Unique Device Identification (UDI) system involves accredited bodies issuing them. Suppliers must then register their UDI data in the European regulatory database, Eudamed. This allows tracking of each device throughout its distribution and use chain.
Preparing for Eudamed integration
Manufacturers are encouraged to start using available Eudamed modules now and register all relevant data to avoid issues when these become mandatory. The database will need to integrate various elements of the technical file, such as:
- UDI number;
- Certificates;
- Clinical investigations;
- Post-market surveillance elements such as the PSUR, etc.
Appointing a Person Responsible for Regulatory Compliance (PRRC)
Regulation 2017/746 requires manufacturers to appoint a Person Responsible for Regulatory Compliance (PRRC). This person must have the necessary qualifications and a thorough understanding of the new regulatory requirements.
Additionally, companies physically located outside the EU must have an authorized representative based in the Union.
What steps should manufacturers of in vitro diagnostic medical devices take?
Adopt a proactive approach
Manufacturers must adopt an anticipatory approach to comply with the new requirements:
- Training staff on the new regulations;
- Updating internal procedures;
- Evaluating existing devices to ensure compliance (transition timeline with milestones for each step of the process), etc.
Implement quality systems compliant with Regulation 2017/746
Establishing effective quality systems is essential to ensure compliance and meet regulatory deadlines:
- Regular internal audits to ensure that all processes comply with IVDR requirements;
- Rigorous documentation to maintain accurate and up-to-date records of all processes, test results, and procedures;
- Continuous staff training on new regulatory requirements and quality best practices.
Collaborate with notified bodies
Manufacturers must establish and maintain close working relationships with notified bodies to facilitate the certification process. This includes:
- Preparing complete and detailed technical files for each device;
- Providing prompt and efficient responses to all clarification requests from notified bodies;
- Planning and preparing for external audits required by notified bodies.
Consult stakeholders
For some Class D devices, consultation with stakeholders such as expert groups and competent authorities may be necessary. This is done by organizing regular meetings and incorporating feedback into device development and evaluation processes.
Use available tools and resources
Manufacturers should leverage available tools and resources to facilitate IVDR compliance:
- Guidelines and standards published by regulatory authorities to ensure that devices meet requirements;
- Specialized compliance software to manage documentation, risks, and compliance reports;
- Training and seminars on IVDR to stay updated on the latest developments and best practices.
Mastering the intricacies of the 2017/746 regulation is essential to ensure the compliance of in vitro diagnostic medical devices. Working with an expert laboratory familiar with the regulations, such as Amarok Biotechnologies, is a time- and efficiency-saving solution.
References:
- https://eur-lex.europa.eu/legal-content/FR/TXT/PDF/?uri=CELEX:32017R0746
- Sara Bouayad Agha. Implementation of the new IVDR 2017/746/EU Regulation for the development of in vitro diagnostic tests: requirements, strategy, and challenges. Pharmaceutical sciences. 2020. ffdumas-03071526f