Software as a Medical Device (SaMD) is a collective term for software used for medical purposes. SaMDs exist as stand-alone products and as parts of other medical devices. Their legal definition varies from country to country. For example, the Medical Device Regulation (MDR) defines them as follows: Software intended to be used alone or in […]
The module for Vigilance and Post-Market Surveillance (PMS) is one of the six modules of EUDAMED. While the proof of medical device safety in the MDD (Directive 93/42/EEC) was still handled quite loosely, the term post-market surveillance is very clearly defined in the Medical Device Regulation (MDR). According to the MDR, manufacturers are obliged to […]
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Anyone wishing to sell products in Russia, whether pharmaceuticals, spirits, or medical devices, must comply with certain regulations and, if necessary, guarantee the traceability of their products. A large-scale track-and-trace project in Russia has been transferring numerous product groups to a track-and-trace system for several years to reduce counterfeit products and illegal trade. According to […]
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The European Commission has published Decision 2025/2371, which officially confirms that EUDAMED meets its functional requirements. In accordance with Article 123(d) of the MDR, EUDAMED will become mandatory six months after publication, i.e. from May 28, 2026. The system was originally supposed to be fully operational in the second quarter of 2024. Additionally, on January […]
The UDI module is the central component of EUDAMED. Manufacturers are required to input their products and relevant information into the database to enhance transparency for patients and ensure traceability. To ensure data quality and compliance, information must be entered accurately and in accordance with EUDAMED’s business rules. As a result, many manufacturers are seeking […]
Read More… from UDI Registration With Master Data Pre-Validation
Even with intensively tested medical devices, unknown side effects can occur among users. If such an incident does occur, it must be documented according to Article 80(2) of the Medical Device Regulation (MDR). The EUDAMED database is the contact point for this respective documentation. In addition, there is a reporting obligation for incidents that have […]
In the European Union, medicinal products and medical devices are only approved for the market if manufacturers can guarantee the safety of their products. If adverse events occur after the products have been placed on the market, the vigilance procedures of the respective industries take effect. This is because patient safety continues to be a […]
With a go-live date for the EUDAMED next year and a deadline for the Medical Devices Regulation (MDR) in the not-too-distant future, it is important to take care of your product data now. There are three ways to upload the data to EUDAMED: using an M2M interface, by manual entry, or via bulk upload of […]
Medical device manufacturers are required by the MDR/IVDR to monitor the safety of their products even after they have been approved and have entered the market. This process is called Post-Market Surveillance (PMS) or Post-Marketing Surveillance. Due to the considerable amount of work involved, it can be advantageous to outsource this process to other companies. […]
Many manufacturers ask themselves whether a clinical evaluation or clinical trial is necessary for their medical devices. The MDR requirements are quite extensive and specific. Various products previously categorized as equivalent under the MDD now belong to a different risk class and existing clinical data are often no longer accepted by notified bodies. The MDR […]