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 […]
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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. […]
On January 06, 2023, the European Commission (EC) published a proposal for the extension of the MDR (Medical Device Regulation) transition periods. This proposal was already adopted on February 16, bringing the extension into force. The obligation of medical device manufacturers to be MDR compliant was thereby postponed several years into the future. Reason for […]
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 […]
A custom-made device in MedTech is a product prescribed to a patient by an authorized person, such as a physician. This product, by prescription, is manufactured exclusively for the respective person. Mass products with adaptions adjusted to fit the user’s needs are not considered as custom-made devices. Custom-made devices were already part of the Medical […]