In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746-IVDR
Navigating Regulatory Compliance Process with Expert Guidance
We offer a customize solution according to the individual needs of manufacturers and the specific characteristics of the medical devices, ensuring a tailored and effective certification process.
From initial product assessment and regulatory strategy development to documentation preparation, submission, and ongoing compliance management, we ensure that every facet of the certification journey is managed efficiently.
Liaison with Competent Authorities and Notified Bodies
We support and guide economic operators in finding a suitable Notified Body for CE certification according to the MDR requirements. Submitting applications to the Notified Body or the Competent Authorities (CA), monitoring the progress of the application and supporting corrective actions.
We assist in communication with Competent Authorities and Notified Bodies during certification process to ensure compliance with regulatory requirements and NBs/CAs’ specific expectations. Our team maintain communication with the CAs addressing any queries, clarifications or comments during submission process.
Data Gap analysis
Our team conducts a thorough assessment of the existing data to address whether they sufficiently cover the requirements of MDR and identify gaps and additional point that should be assessed.
Device Classification according to IVDR (Classes A, B, C, D)
According to Regulation (EU) 2017/746, in vitro diagnostic medical devices are divided into classes A, B, C and D taking into account their intended use and their inherent risks. In order to proceed with the assessment of conformity and the compilation of the Technical documentation, the risk class of the device is initially determined and justified according to the classification rules listed in Annex VIII.
Technical Documentation compilation- CE certification
The technical documentation of the medical device includes the collection, description and justification of all the characteristics of the medical device, its design, production process and all the measures taken by the manufacturer to ensure the compliance of the product with the requirements of the Regulation (EU) 2017/745. Our team of experts support the manufacturers to collect all the appropriate data and prepares the required documentation.
Performance Evaluation Plan (PEP) & Report (PER)
Τhe Performance Evaluation Report constitutes a compilation of the Scientific Validity Report, Analytical Performance Report, and Clinical Performance Report are collated in
Scientific Validity Report (SVR)
Scientific Validity Report entails establishing a connection between an analyte and a clinical condition or physiological state. This association forms the basis for the entire process of developing and producing an In Vitro Diagnostic (IVD) product. It serves as a justification for demonstrating the overall safety and performance of the IVD, ensuring its reliability and accuracy in clinical use.
Analytical Performance Report (APR)
For every device or device group, it’s essential to establish analytical performance plans and protocols. In this context, the manufacturer ascertains the device’s precision in detecting and measuring the analyte accurately. This is commonly achieved through a series of analytical performance studies, involving laboratory tests and certified reference materials.
Clinical Performance Report (CPR)
Clinical Performance Plan and Report provides information regarding the parameters such as diagnostic sensitivity and specificity, positive and negative predictive values and likelihood ratios, expected values in normal and affected population, and also the sample collection and handling requirements for the devices. It may contain data from scientific literature, testing or clinical studies.
Post-Marketing Surveillance Documents (PMS, PMPF, PSUR, Vigilance)
Our team of experts in collaboration with the manufacturer set up a PMS plan describing all the actions that will be implemented by the manufacturer during the lifetime of the device to monitor its safety and performance. All the results are gathered and analyzed in suitable reports depending on whether the results concern performance data or aggregated data.
Registration of economic operators and medical devices to the national database of medical devices in accordance with the requirements of national regulation of the corresponding country (namely GreMDIS, Cyprus, BFARM etc).
Our experts assist in the registration of an economic operator in EUDAMED and the acquisition of SRN, registration of medical devices and management of active modules of the European EUDAMED database.