MDR Regulator provides design, testing and launch support for medical device companies seeking to expand into European markets.
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MDR Regulator offers services to help medical device and in-vitro diagnostic (IVD) medical device manufacturers introduce their products into European markets, ensure the continuity and compliance of their operations with the relevant European regulations, and begin registration activities in other global markets.
We aim to comprehensively support manufacturers in bringing high-quality devices to market. Our services cover all points of the product launch process, including pre-clinical studies, clinical investigations and performance studies, device registration, and post-marketing activities.
Together with our subsidiary Pure Clinical, MDR Regulator distinguishes the uniqueness of its services to the medical device and IVD industries.
MDR Regulator consists of a team of specialists with extensive experience in regulatory affairs, medical technology, quality management, clinical research, business management, and marketing. We monitor all regulatory changes to adapt to the dynamically changing environment. We have a rich history in cooperation with notified bodies, competent authorities, accreditation bodies, and the European Commission.
MDR Regulator focuses on transparency and honesty in customer relations, with a particular emphasis on efficiency and effectiveness. This is the result of our team’s experience in introducing medical devices to the European Union (EU) and other overseas markets.
When working with clients, MDR Regulator listens to their needs and learns how they operate. Our individual approach to each project allows us to find solutions tailored to each client’s needs. We cooperate with clients based on values such as:
MDR Regulator offers a full range of services related to trials and performance studies of medical devices, including IVD devices, in accordance with current regulations and standards. This allows us to confirm device safety and efficacy based on reliably collected and analysed clinical data.
We cooperate with experienced clinical sites in the EU, including district, clinical and specialist hospitals, private laboratories, and university units. We know how to apply to local Independent Ethics Committees and National Competent Authorities.
Our customers can rely on us to:
MDR Regulator serves as an authorised representative under SRN: PL-AR-000002485 and is responsible for regulatory compliance as an external partner, allowing us to help manufacturers comply with European regulatory requirements. Among other services, we can develop and verify device technical documentation, make technical documentation available for inspection by competent authorities, assist with device certification, and provide device registration and support for product safety activities, as well as medical incident reporting.
MDR Regulator supports medical device manufacturers in supervising complaints and other market feedback, participates in the evaluation of user information, conducts usability studies and post-market surveillance studies, offers OBL/OEM cooperation consulting services, and supports the quality management process through implementation, maintenance, and QMS verification.
The regulatory strategy is the first and extremely important element of the medical device design process, which initiates the activities necessary to define the project schedule and leads through the device development process until implementation.
The new Regulation (EU) 2017/746 (IVDR) has introduced stricter and more detailed requirements for conducting performance studies of in vitro diagnostic medical devices (IVDs) compared to the previous Directive 98/79/EC (IVDD).
May 26, 2022, marked a significant milestone for manufacturers of in vitro diagnostic medical devices.
In the first part of the article "Changes in clinical trials of medical devices - new requirements, ways to report and supervise clinical trials. Part I.", we discussed such aspects as registration, how to report and supervise clinical trials, and the requirements for the necessary clinical trial documentation.
Innovation in the medical device market and its real impact on the market and the economy are strongly linked to meeting the relevant regulations at the national and European levels. Therefore, with such a significant change as the introduction of new requirements for clinical trials of medical devices across the European Union (EU) in May 2021, it is important for the medical device industry to familiarise itself with the differences, potential impacts and necessary actions in this regard. This is in order to adequately prepare for the introduction of innovative products or the adaptation of products currently on the market and prevent shortages in the availability of lifesaving and health-saving technologies.
