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April 15, 2024The EU Commission published a new dashboard. It contains data from a study on the reprocessing of single-use devices (SUDs). It includes information such as, which member states allow/don’t allow reprocessing of SUDs, and which Notified Bodies are certifying/not certifying SUDs.
The dashboard is available: HERE
Background
The MDR (Article 17) permits each Competent Authority to determine if they will allow reprocessing of single-use devices in their market.
Any natural or legal person who processes a single-use device (i.e., products that were initially CE Marked and labeled for single-use), in order to make it suitable for further use, is considered to be the legal manufacturer of the reprocessed device. As a result, they shall assume all the same manufacturer obligations (Article 10) as laid out under the MDR. And, they shall consider other obligations, such as outlined under Commission Implementing Regulation (EU) 2020/1207 (Common specifications for the reprocessing of single-use devices).
The exception is when the reprocessing is undertaken by health institutions. Per MDR, Article 17(3), Member States may, under certain conditions, decide not to apply all of the rules relating to manufacturers’ obligations.
Where reprocessing is allowed, manufacturers must validate that the device is suitable for reprocessing. This assessment should consider factors such as the product’s material composition, construction, and technical characteristics.
Examples of products considered not suitable for reprocessing include devices that emit radiation, are implantable, have internal data storage necessary for their use, and/or have cutting or scraping blades, drills, or components wearing off, that are no longer suitable after the first use and cannot be changed or sharpened before the next medical procedure.
Overview
The dashboard provides an overview of the study’s results, which include sections on Competent Authorities, Notified Bodies, Manufacturers, and Health Institutions.
Further, where a member state does allow reprocessing of single-use devices (SUDs), the legal basis is provided (if already available).
Below are examples of the data included. Please refer to the dashboard for comprehensive details.
