MDR certification (NieuwhuisConsult)
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MDR certification (NieuwhuisConsult)

MDR certification (NieuwhuisConsult)

Before a medical device is placed on the European market, manufacturers must provide technical documentation showing that they comply with the relevant legislation. From May 25, 2020, all medical devices marketed in Europe must comply with new rules. Namely the European Medical Device Regulation (MDR). This often goes together with ISO 13485. The new MDR will also apply to medical devices that have been on the market for years. This will include stricter rules for the safety and traceability of medical devices. Two main things that the manufacturer must take into account are: Compliance with new requirements for technical documentation In short, as a manufacturer or distributor you have to update the technical documentation to comply with the new Regulation. Comply with the new PMS requirements Manufacturers must implement all MDR PMS requirements from May 25, 2020, even if the affected devices are still marketed under the MDD / AIMDD. All medical devices will have to meet the new requirements from 2020 and must be registered in the European database Eudamed in order to be sold. In short, there are many changes that need to be implemented. It is recommended to perform an impact analysis on the current portfolios of the manufactured medical devices in order to meet the changed requirements. Nieuwhuis Consult is happy to help you with this.

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