Tuttlingen – The fact that information according to EU-MDR as well as MDD can be noted on free sale certificates causes confusion in some non-European destination countries: A new FAQ document from MedicalMountains GmbH, which can be obtained free of charge, now supports communication.
A free sale certificate, FSC for short (Free Sales Certificates), is actually intended to make international goods traffic easier. The opposite is often the case with medical devices. Declarations of conformity have already been issued in accordance with EU-MDR, but many are still valid under MDD until May 2024 at the latest, which is also reflected in the FSCs. "Companies are repeatedly asked questions," reports Managing Director Julia Steckeler, "since, for example, one product has the UDI-DI and the number of the notified body, as is consistent with EU-MDR, and another product does not, because it is still on the market after MDD.” The information is different, but correct in each case – not every clerk in every country understands it straight away. The result is a back and forth of messages and basically unnecessary extra work.
Against this background, the request for a neutral document was approached to MedicalMountains GmbH, which could be submitted as a standard and which describes the facts. The result is now available in the form of an FAQ paper in English. "The aim is to answer a series of questions about the transitional provisions that are frequently asked from abroad in the context of product registration," says Julia Steckeler. In addition to basic information on the regulations, the risk classes are considered and information in the FSCs is justified - any information that may be missing under the MDD. It was created from general information from the Baden-Württemberg Ministry for Social Affairs, Health and Integration and the regional councils in Baden-Württemberg. Julia Steckeler is grateful for this cooperation. "It shows once again that everyone is pulling in the same direction." Even if the document is ultimately neither official nor legally binding, it can support companies in communication and speed up processes. "A lot would be gained with that and it would be a great help, especially for smaller companies with limited human resources," says the MedicalMountains managing director.
The document can be obtained free of charge from the web shop under this link.
