On May 26, 2022, In Vitro Diagnostic Directive (IVDD) will be replaced by In Vitro Diagnostic Medical Device Regulation (IVDR), introducing a new approach to how in vitro diagnostic devices (IVDs) will be regulated in the European Union (EU).
Under IVDD, 93% of IVDs were self-certified products but this won’t be the case under IVDR. Nearly 85% of all IVDs would require notified body involvement, leaving only 15% of IVDs eligible for self-certification.
Gearing up for the transition to IVDR? Is your team aware of the new product classifications? Have you re-evaluated your supply chain and contractors? What about post-market surveillance?
Listen to this webinar, by MDR and IVDR expert Sundeep Agarwal, to find answers to these questions and more.
What is EU-IVDR?
The European Commission’s (EC) in vitro diagnostic regulation (EU IVDR 2017/746), which would come into effect from May 26, 2022, is a legislative framework replacing the previous IVD directives to enable reliable and effective IVDs. The amended directives include regulatory changes and requirements to enhance the safety and efficacy of IVDs for non-EU manufacturers and economic operators with commercial operations in the European Economic Area (EEA).
Key Elements of IVDR
The following are important aspects to note to meet IVDR requirements:
New Product Classificatio: The IVDR brings out a risk-based classification system similar to the MDR. The risk classes range from class A to class D (class A is the lowest and class D is the highest risk class). The involvement of a Notified Body is required for Class B, C, and D products.
Technical Documentation: It demands exhaustive technical documentation, requiring a very robust and stringent quality control system. The requirements of technical documentation under the IVDR follow a certain set of guidelines. Manufacturers can benefit from the ComplianceQuest EQMS, which includes a document management system that is built for ease of collaboration and version control.
General Safety and Performance Requirements: The General Safety and Performance Requirements are listed in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. The manufacturers should follow these requirements and must have enough evidence of conformity to prove that they have complied with GSPR if they need to get their product CE marked.
Unique Device Identification (UDI): Under the IVDR, each manufacturer is required to implement a Unique Device Identification system. The European Commission and Medical Device Coordination Group (MDCG) issued some guidance documents, e.g., on Basic UDI-DI and UDI-DI attributes, which will be used for the registration in EUDAMED.
The European Databank on Medical Devices (EUDAMED : Under the IVDR, EUDAMED serves as a consolidated database for the registration of economic operators and products and aids in vigilance reporting and performance studies.
Performance Evaluation Under the IVDR
Performance evaluation of a device is a perpetual process by which data is evaluated and analyzed to testify the scientific validity, analytical performance, and clinical performance of that device for its intended purpose as stated by the manufacturer. Annexure 13 defines performance evaluation.
There are three things we need to follow here:
- Specify the characteristics and performance of the device
- Process and criteria applied to generate clinical evidence
- Be thorough and objective
- Specify intended purpose/ use
- Target patient group
- Use statistical tools for examination of analytical and clinical performance
- Scientific validity, analytical, and clinical performance
- Conduct a systematic scientific literature review
- Appraisal of relevant data sources – research papers, consensus expert opinions, proof of concept studies, result from clinical performance studies
- Scientific validity report
- Analytical and clinical performance report
- Justification for the approach
- Literature search methodology
- Technology on which device is based, intended purpose and claims made
- Conclusion from PMPF
Post-Market Surveillance Under The IVDR
Post-Market Performance Follow-Up (PMPF) plays an important role under the IVDR, where post-market data is used to update essential documents such as risk management and performance evaluation. Manufacturers are required to produce the PMS Plan and Report/Periodic Safety Update Report (PSUR) in accordance with the IVDR.
Role of Notified Body
All class B, C, D, and sterile devices shall be audited and granted CE certification by a Notified Body. The Notified Body shall make arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers to carry out product tests and the monitoring of compliance. The Notified Body shall also randomly perform unannounced audits at least once every five years on the site of the manufacturer (where appropriate, manufacturer’s suppliers and subcontractors) either with periodic surveillance or in addition to it.
How Can You ‘CE Mark’ Your Product?
The CE marking process may include a few or all of the following steps depending on the relevant directives and their product safety requirements:
- The first step is to identify the directives that are applicable to the product.
- Recognize the requirements of the product, and for each directive, detail what is legally required for product compliance.
- The following step is to determine if a third-party assessment is needed. Some directives require that products be tested and authorized by a third-party organization to ensure compliance with the applicable requirements.
- You should test or verify your products from a EU reference lab to ensure that your products meet the requirements of the relevant EU directives.
- Manufacturers must compile technical documentation that includes information about the design, production, and use of the product. It also includes essential information to show that a product carrying the CE marking symbol meets the necessary product safety requirements.
- Once the technical documentation is ready, the manufacturer should officially state that the product meets all relevant product safety requirements of the applicable CE marking directive(s) by signing a Declaration of Conformity. Declaration of Conformity is a legal document by which the manufacturer of a product ensures that the product meets the crucial requirements in the relevant CE directive(s).
- The final CE marking process is product labeling. They can affix the CE marking symbol to the product’s surface or its data plate and on the packaging. The correct marking along with the Declaration of Conformity demonstrates that the product is compliant with the CE marking legislation.
Managing the IVDR Transition with ComplianceQuest EQMS
ComplianceQuest’s EQMS solution is designed to manage the entire product lifecycle right from well-established technical documentation, procedures, document management, change control, design control, CAPA, etc. This can help with meeting IVDR requirements more intuitively and enable automating the various quality areas, helping auditors evaluate the process, data quality and integrity. For a successful outcome, manufacturers including economic operators (Importers, Authorized Representatives, Distributors) must work closely and cooperate with the Notified Bodies, suppliers, and sub-contractors of the European Commission, and Competent Authorities to ensure the legislative framework is successfully adopted and safe products are continually available to the patients in need.
Some of the ComplianceQuest EQMS’s features that enable this include:
Cloud based system: ComplianceQuest’s cloud-based EQMS provides real time data analysis and updates that play a key role to be 24/7 audit ready.
Digital change management: Unless QMS documentation is digitally managed, change management will be erroneous or would lack updating.
Suppliers and sub-contractor controls: Convey the IVDR requirements to the suppliers and ensure new agreements are in place.
Post market surveillance and vigilance: A procedure to perform PMS and vigilance should be in place and it should be continuously updated.
Internal and external communication : real time communication with quantifiable data within and external to the organization is essential.
Watch our demo to know more about how ComplianceQuest can help you transition to the new Directive