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 […]
Read More… from Registration and Digital Marking of Medical Devices in Russia
In October 2023, the European Commission extended the transition period for EUDAMED’s introduction. The system was supposed to be fully functional in the second quarter of 2024. This and other deadlines have now been postponed by three years. The EU has not published an official explanation. However, it has been known for some time that […]
An essential part of the Medical Device Regulation (MDR) is the European Database on Medical Devices (EUDAMED). Manufacturers are required to enter their products, including relevant information, into the database to create greater transparency for patients. The six associated modules will be published step by step. At the time of publication, it is still two […]
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 […]
The extension of the MDR transition periods came at the right time for many companies. A survey by the Medical Device Coordination Group (MDCG) in April 2022 found that a total of 85% of medical devices certified under the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) are not yet certified for […]
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. […]