Product Registration

Why Product Registration Matters

Product registration serves as the gateway for medical devices to enter the market and be made available for clinical use. It is a regulatory requirement aimed at safeguarding patient safety, ensuring product effectiveness, and upholding quality standards. By registering their devices, manufacturers demonstrate compliance with relevant regulations and provide assurance to regulatory authorities and end-users regarding the safety and performance of their products.

Navigating the Regulatory Landscape

In the EU, medical device registration is governed by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Manufacturers must register their devices in the European Database for Medical Devices (EUDAMED), a centralized repository for information on medical devices available in the EU market.

Following Brexit, the UK introduced its own regulatory framework for medical devices, including the UK Conformity Assessed (UKCA) marking. Manufacturers intending to market their devices in the UK must register them with the Medicines and Healthcare products Regulatory Agency (MHRA) and comply with the UK Medical Devices Regulations.

Similarly, Switzerland requires medical device registration through its regulatory authority, Swissmedic. Manufacturers must submit the necessary documentation and obtain approval before their devices can be marketed in Switzerland.

Key Databases for Registration

1. EUDAMED: The EU's central database facilitates the exchange of information between national competent authorities and enables the registration of devices, economic operators, and clinical investigations.
2. MHRA Device Online Registration System (MDR): This platform allows manufacturers to register their medical devices for market access in the UK and obtain the UKCA marking.
3. Swissmedic: Switzerland's regulatory authority manages the registration process for medical devices and ensures compliance with Swiss regulations.

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MedNet EC-REP GmbH stands ready to support manufacturers in their journey towards successful product registration and market entry.

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