As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction of the EU In-Vitro Diagnostic Regulation; one of these changes is the introduction of the EU Reference laboratories.
We have been already discussing about several topics related to IVDR 2017/746, such as the new classification system or Article 110 related to the obligations during the transition period and the requirement related to companion diagnostic IVD devices; in this article we will discuss in details the establishment and the related requirements for the EU Reference Laboratories.
Responsibilities for the EU Reference Laboratories
The requirements pertaining to EU Reference Laboratories are outlined in Article 100 of the EU IVDR. These specialized laboratories have a range of significant responsibilities that we will discuss in detail below.
First and foremost, EU Reference Laboratories are entrusted with the crucial task of verifying the manufacturer’s performance claims and ensuring the compliance of Class D devices with the relevant common specifications. This responsibility holds utmost importance as it ensures the reliability and accuracy of the claims made by manufacturers. Additionally, depending on the specific conformity assessment chosen by the manufacturer, EU Reference Laboratories are responsible for conducting appropriate tests on samples or batches of manufactured Class D devices.
Furthermore, these laboratories are mandated to provide scientific and technical assistance to various entities, including the Commission, the Medical Device Coordination Group, Member States, and notified bodies, concerning the implementation of the IVDR regulation. Their expertise may be sought in various areas, including defining the state of the art in relation to specific devices or technologies. By offering scientific support, EU Reference Laboratories contribute to the development and advancement of medical device regulations.
Collaboration with notified bodies in the conformity assessment procedures for IVD devices is another critical responsibility of EU Reference Laboratories. They work in tandem with notified bodies to ensure that appropriate testing and analysis methods are employed during the conformity assessment processes and market surveillance activities. This collaboration helps maintain consistency and reliability in the evaluation and certification of IVD devices.
Moreover, EU Reference Laboratories play an active role in the development of novel reference materials and reference measurement procedures. Their contribution to the creation of these resources aids in enhancing the accuracy and precision of diagnostic tests. Additionally, they collaborate in the development of common specifications and novel ISO standards, thereby facilitating harmonization and standardization within the industry.
Finally, as stipulated by the EU IVDR, notified bodies have the option to seek consultation from EU Reference Laboratories on specific topics. These consultations are intended to address complex issues and ensure that the most accurate and informed decisions are made. The outcomes of these consultations are then published, contributing to the overall transparency and knowledge sharing within the regulatory landscape.
In conclusion, EU Reference Laboratories have a diverse range of responsibilities that encompass verifying performance claims, conducting tests, providing scientific support, collaborating with notified bodies, contributing to the development of reference materials and standards, and offering consultations on specific topics. Their expertise and contributions are instrumental in upholding the highest standards of quality, safety, and effectiveness for in vitro diagnostic devices in the European Union.
Requirements for EU Reference Laboratories
Continuing with the provisions outlined in Article 100 of the regulations, specific criteria that must be met by EU Reference Laboratories are clearly defined. These criteria encompass the following:
- Appropriate Qualified Human Resources: EU Reference Laboratories must have highly skilled personnel who possess specific knowledge and experience in the field of in vitro diagnostic medical devices for which the laboratory is designated. These professionals bring valuable expertise to ensure accurate and reliable evaluations.
- Adequate Infrastructure: The laboratories should possess the necessary infrastructure, including equipment and reference materials, to effectively carry out the activities and tasks assigned to them. This ensures that the laboratories are equipped with the resources needed to conduct reliable assessments.
- Knowledge of International Standards: Personnel working in these laboratories should have a comprehensive understanding of international standards and best practices, particularly in the field of IVD devices. This knowledge enables them to effectively evaluate compliance and ensure adherence to established standards.
- Appropriate Internal Structure and Organization: The laboratories must have a well-defined internal structure and organization that supports their activities. This includes appropriate management systems, documentation procedures, and quality control measures to facilitate smooth operations.
- Confidentiality: To maintain the integrity of their work, the laboratories must have robust processes and procedures in place to ensure the confidentiality of the information and data obtained during their tasks. This helps safeguard sensitive information and protect the interests of all stakeholders involved.
- Independence and Public Interest: EU Reference Laboratories are expected to operate with an adequate level of independence, ensuring that their actions are driven by the public interest. This independence allows them to conduct unbiased assessments and provide reliable recommendations.
- Management of Impartiality: It is crucial for the laboratories to effectively manage the impartiality of their staff. They should establish mechanisms to prevent conflicts of interest and maintain a high level of objectivity in their evaluations. Staff members are required to declare any direct or indirect interests they may have in the in vitro diagnostic medical device industry and regularly update these declarations to ensure transparency and accountability.
By meeting these criteria, EU Reference Laboratories can effectively fulfill their responsibilities and maintain the highest standards of expertise, integrity, and professionalism. These requirements contribute to the overall credibility and reliability of the evaluations and assessments conducted by these laboratories, instilling confidence in the regulatory framework and promoting the safety and effectiveness of in vitro diagnostic medical devices.
Audits and other forms of Control
As defined in Article 100 of the EU IVDR 2017/746, EU reference laboratories are subject to thorough controls and oversight by the Commission. These controls, including on-site visits and audits, are conducted to verify and ensure compliance with the requirements stipulated in the EU IVD Regulation. This robust monitoring process is essential for maintaining the integrity and reliability of the EU reference laboratories and their assessments.
The Commission has the authority to take necessary measures if an EU reference laboratory is found to be non-compliant with the designated requirements. Such measures may include restrictions, suspension, or withdrawal of the laboratory’s designation. These actions are taken to safeguard the regulatory framework and uphold the highest standards of quality and accuracy in the evaluation of in vitro diagnostic medical devices.
The controls and audits conducted by the Commission serve multiple purposes. Firstly, they act as a means of verifying the ongoing adherence to the established requirements by EU reference laboratories. These assessments help identify any potential areas of non-compliance, allowing for timely corrective actions to be implemented.
Furthermore, the on-site visits and audits provide an opportunity for knowledge sharing and continuous improvement. The Commission can provide guidance and support to the EU reference laboratories, fostering an environment of collaboration and mutual growth. By maintaining a strong relationship between the Commission and the laboratories, ongoing compliance can be ensured, leading to enhanced regulatory oversight and public confidence in the evaluation process.
It is crucial for EU reference laboratories to recognize the importance of meeting the designated requirements and undergoing regular controls and audits. Compliance with these measures not only guarantees their continued designation but also upholds the overall integrity and effectiveness of the EU IVDR. By adhering to the requirements and cooperating with the Commission, EU reference laboratories contribute to the robustness of the regulatory framework and the safety of in vitro diagnostic medical devices within the European Union.
Conformity Assessment involving EU Reference Laboratories
As mentioned previously, the conformity assessment process for class D IVD devices entails a specific requirement when one or more EU reference laboratories have been designated. In such cases, the notified body responsible for the assessment is required to seek verification of the device’s claimed performance and its compliance with the applicable common specifications. The regulation explicitly states that laboratory tests conducted by an EU reference laboratory should primarily focus on analytical and diagnostic sensitivity, utilizing the most reliable and accurate reference materials available.
The involvement of EU reference laboratories adds an extra layer of scientific expertise and scrutiny to the assessment process. These specialized laboratories are entrusted with the task of thoroughly evaluating the performance and compliance of class D IVD devices. Their scientific opinion plays a crucial role in providing an objective assessment of the device’s analytical and diagnostic sensitivity, ensuring its accuracy and reliability in clinical settings.
In accordance with the regulatory timeline, the EU reference laboratory is required to provide its scientific opinion within a specified timeframe of 60 days. This ensures a timely and efficient assessment process, allowing manufacturers to proceed with the necessary steps towards obtaining regulatory compliance and market access for their class D IVD devices.
It is important to note that the involvement of EU reference laboratories not only strengthens the credibility of the assessment but also contributes to harmonization and standardization within the IVD industry. By relying on the expertise of these designated laboratories and their use of validated reference materials, a consistent and reliable evaluation of class D IVD devices is achieved across the European Union.
The integration of EU reference laboratories in the conformity assessment process reflects the commitment to maintaining the highest standards of quality, accuracy, and scientific rigor. Their contribution helps ensure that class D IVD devices meet the stringent requirements set forth by the EU IVDR, fostering confidence in the safety and performance of these advanced diagnostic tools.
Conclusions
In conclusion, we have been discussing the requirements related to the EU Reference Laboratory, as described in the In-Vitro Diagnostic Regulation 2017/746. Among their reponsbilities, there is the necessity to confirm performant requirements claimed by the manufacturers, according to the specific common specifications.
Subscribe to 4EasyReg Newsletter
4EasyReg is an online platform dedicated to Quality & Regulatory matters within the medical device industry. Have a look to all the services that we provide: we are very transparent in the pricing associated to these consulting services.
Within our WebShop, a wide range of procedures, templates, checklists are available, all of them focused on regulatory topics for medical device compliance to applicable regulations. Within the webshop, a dedicated section related to cybersecurity and compliance to ISO 27001 for medical device organizations is also present.
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
Do not hesitate to subscribe to our Newsletter!
