The UDI requirements in Australia align with two additional regulations that will require medical device manufacturers to enter their products (partially) into the respective […] […]
Read More… from UDI Requirements in Australia: TGA Guidelines, Timeline, and Labelling Obligations
(UDI) is a key requirement under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). For MedTech manufacturers, UDI compliance means correctly assigning and managing product identifiers […] […]
Read More… from What Do You Need for EUDAMED UDI Compliance?
After numerous delays, the first four modules of EUDAMED have now been audited, and their use will become mandatory in six months. This has been confirmed by the publication in the Official Journal of the […] […]
By mid to late November, the European Database on Medical Devices (EUDAMED) is expected to be officially declared “fully functional.” For manufacturers, this means the UDI registration process is becoming a reality. […] […]
Under the EU Medical Device Regulation (MDR), vigilance plays a key role in patient safety and transparency in the MedTech industry. EUDAMED serves as the central platform for submitting these reports. […] […]
Read More… from Vigilance Reporting in EUDAMED: An Overview for Medical Device Manufacturers
Authorized Representatives (ARs) carry significant responsibility toward their clients and actively contribute to traceability and product safety through collaboration with stakeholders such as importers. In this FAQ, we clarify responsibilities under MDR and […] […]
Read More… from FAQ: Authorized Representatives – Managing EUDAMED UDI Data
In the Vigilance module of EUDAMED, manufacturers, importers, and authorized representatives will be required to upload their Post-Market Surveillance (PMS) reports. For notified bodies and […] […]
Small and medium-sized enterprises (SMEs) often struggle with the complexity of the Medical Device Regulation (MDR). A clear UDI strategy can help standardize processes and ease the regulatory burden. […] […]
Read More… from How to Develop an International UDI Strategy Based on EUDAMED-UDI
The Single Registration Number (SRN) is the most important identifier for all economic operators working in EUDAMED. It serves for unique identification across Europe in the European Database on Medical Devices (EUDAMED) […] […]
Electronic Instructions for Use (eIFU) are digital versions of traditional printed instructions for medical devices. They offer numerous advantages, including improved accessibility and reduced paper consumption. The current situation in the EU, global regulations, and future requirements for medical device manufacturers are discussed in the following article. In Europe, eIFUs have been a topic since […]
Read More… from Electronic Instructions for Use (eIFU) for Medical Devices