We are specialized in substance-based medical devices consisting of single substances or combinations of substances. These products are typically similar or equivalent to pharmaceutical products available in pharmacies and retail outlets. House of MDR provides comprehensive regulatory services for your devices.
Regulatory and clinical strategy planning for medical devices is a comprehensive process that creates a roadmap for a device’s market approval and lifecycle management. Key components are defining the intended use and classification, selecting the appropriate regulatory pathway, and developing a clinical evaluation plan to gather necessary evidence. Early planning during the design phase is crucial to minimize delays and costs by aligning timelines and requirements for different markets.
The technical documentation provides information on the design, manufacture, and operation of a medical device and must contain all the details necessary to demonstrate the medical device conforms to the applicable requirements.
House of MDR is specialized IFU process and its content
EU MDR 2017/745 establishes the general requirements for instructions for use (IFU). (Annex 1: GSPR Chapter III,23.1.) Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.
We offer comprehensive support tailored to specific requirements of your medical device, ensuring a smooth path to regulatory compliance.
The process of submitting to a notified body (NB) is an essential step in obtaining CE marking for MDR-compliant medical devices in the EU.
House of MDR is providing support and daily tasks relating to Eudamed, like user and data management. We keep your Eudamed data up-to -date promptly.
Eudamed is a database that monitors the safety and performance of medical devices. Its main goal is to enhance overall transparency by providing better access to information for the public and health care professionals. Eudamed is a very complex system. Using the system will require a lot of understanding from the end-users.
House of MDR will draw up and maintain up to date the declaration of conformity (DoC) on behalf of manufacturer. DoC is the proof justifying that technical documentation of your medical device meets the essential requirements.
The EU Medical Device Regulation (MDR) mandate that medical device manufacturers appoint a ‘Person Responsible for Regulatory Compliance’ (PRRC). Compliance with this requirement is necessary for selling products in the European market. At House of MDR, our PRRCs possess the required expertise regarding a wide variety of medical devices and qualifications in medical devices, ensuring effective adherence to regulatory standards and ensuring compliance and safety throughout the process.
The “transitional period of legacy medical device” refers to an extended time frame for older devices to transition to new regulations, (MDR). During this period, the device must still comply with the original directive MDD, but also meet new MDR requirements for post-market surveillance, vigilance, and device registration. To qualify for an extended period, a manufacturer must have applied for MDR certification and signed a contract with a Notified Body.
