Medical Devices-Regulation (EU) 2017/745 (MDR)
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.
Medical device classification
According to Regulation (EU) 2017/745, medical devices are classified as class I, IIa, IIb and III, 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 medical 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.
Clinical evaluation of medical devices is conducted by our team experts through a systematic, in-depth review of scientific literature, real-world evidence, post-market data and analysis of available clinical studies, in order to assess the performance and safety of the medical device. Clinical evaluation is tailored to the specific device, its intended purpose and its characteristics. It follows a well-structured procedure based on international guidelines such as MEDDEV 2.7/1 and the MDR’s requirements for clinical evaluation.
Biological evaluation in accordance with ISO 10993
Medical devices undergo a rigorous biological evaluation in accordance with ISO 10993 guidelines. Our experts conduct biological evaluation of medical devices within a risk management process considering factors such as available toxicological data, raw material properties, manufacturing procedures, medical device configuration and specific characteristics. The results of the evaluation and biocompatibility testing of the device such as cytotoxicity, irritation, sensitization, systemic toxicity are presented in a biological evaluation report.
Risk management in accordance with ISO 14971
Taking into consideration the characteristics of the medical device, its use, design and production process, the manufacturer must identify and analyse all the identified and potential risks deriving from the use of product and implement measures to reduce them as far as possible. Risk management is a lifelong process as the risks and the applicable measures should be monitored after certification is completed. The Risk Analysis includes the development of an appropriate risk management plan and risk management report, which include the detailed analysis of the risks associated with the device and their mitigation measures according to the manufacturer’s procedures.
Post-market surveillance plan (PMS plan)
The post-market surveillance plan describes the procedures and methods followed by the manufacturer to collect information actively and systematically on the safety, efficacy and quality of the device throughout its life. It is prepared taking into consideration the classification, type and risks of medical device.
Post-market surveillance report-Periodic Safety Update Report (PSUR)
A Periodic Safety Update Report (PSUR) should be prepared for medical devices of class IIa, IIb and III, in accordance with the timelines set in MDR and the procedures described in Post market surveillance plan of the manufacturer.
Post-market clinical follow-up (PMCF) plan and report
Post-market clinical follow-up plan describes the methods followed by the manufacturer to collect clinical data after placing a device on the market focusing on clinical experience as well as new developments on the market.
Economic operators and especially manufacturers should have an established system for monitoring, reporting and detecting adverse effects, informing competent authorities about these adverse effects when appropriate and implementing corrective and preventive measures related to these reports. We assist economic operators to develop and implement a vigilance system.
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.
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).
Compliance support for distributors and importers
Medical device importers and distributors should comply with the requirements set in article 13 and 14 respectively of Regulation (EU) 2017/745 on Medical Devices, as well as with the national requirements imposed by the corresponding competent authorities. Our experts guide economic operators through the requirements of MDR and the necessary measures that should be implemented for compliance. We facilitate the communication with the competent authorities and registration of the medical devices.
Our team designs and conducts introductory and specialized training seminars in Regulation (EU) 2017/745, tailored to the specific needs and obligations of the participants. Trainees gain deeper understanding of the basic concepts and the requirements outlined in MDR, in order to develop a solid regulatory strategy for continuous compliance with the Regulation.