On December 31, 2020, the Brexit transition phase ended, along with the validity of EU regulations in the UK. Since leaving the EU, the United Kingdom (UK) has been struggling with corresponding hurdles. There is a shortage of workers in some sectors, sales to the EU have decreased, and there have been significant costs associated […]
Before the 2017 adoption of the Medical Device Regulation (MDR) and thus EUDAMED, there were already national databases for medical devices in the EU countries. As in many aspects of the economy, the European medical device market was highly fragmented before the introduction of the MDR. Therefore, it was and is difficult for manufacturers to […]
With the launch of ChatGPT on November 30, 2022, artificial intelligence (AI) experienced a huge boom worldwide. Within two months, 100 million people had registered for the chatbot developed by OpenAI. The already prominent topic developed into a megatrend in a short space of time. ChatGPT and competing products such as Google’s Gemini are generative […]
Since the Medical Device Regulation (MDR) was published in 2017, we witnessed many changes and deadline postponements. It is also likely that there will be more in the future. For medical device manufacturers, the most significant change has been the extension of the transition periods for the MDR and EUDAMED. Some medical device companies expressed […]
Read More… from MDR preparation – How to deal with the EUDAMED postponement?
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 […]
Read More… from Post-Market Surveillance – Challenges of Data Collection
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 December 2024, 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 with the last announcement. The EU has not published an official explanation. However, it has been known for some time […]
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 […]