UDI EU Add-On & EUDAMED Updates
Dear Sir or Madam,You have participated in our UDI EUDAMED Webinar 2021, so you are aware of the challenges medical device manufacturers face with the Medical Device Regulation of MDR2017/745…
Category News
MDR entry into force: situation in Switzerland
The Medical Device Regulation (MDR) is about to apply in the European Union, starting on 26 May 2021. Since Switzerland is not a member state, this regulation does not apply…
Maximum number of reuses of device
Information on the maximum number of reuses of devices and their implications on UDI for MDR 2017/745 compliance was recently provided by the MDCG in the Guidance on BASIC UDI-DI…
Transitional provisions for the certification of in vitro diagnostic medical devices class D
The IVDR provisions must be applied before May 26, 2022 (during the transition period). As obscurity still remains, the Medical Device Coordination Group (MDCG) recently published indications on how to deal…
UDI World Overview April 2021 state
The UDI (Unique Device Identification) field is still evolving and is more or less advanced depending on the country. If you are in any way related to the medical devices…
Custom-made Device (CMD) according to MDR (2017/745)
The variety of medical devices is also expressed in their different forms. These are an important factor influencing the legal status and the way in which the medical device is…
UDI Compliance during Brexit
The UK's exit from the European Union has a great impact on many companies and the medical device business. The following article summarizes the upcoming changes and explains what to…
Practices and solutions until EUDAMED deployment
The European Medical Devices Database (EUDAMED) is not expected to be operational and fully functional with all its 6 modules before May 2022. Nevertheless, the effective date of the Medical…
UDI format for GS1 & HIBC
The format of your UDI codes, Basic UDI-DI and UDI-DI, depends on the selected Issuing Agency. For the two most commonly used Issuing Agencies, GS1 and HIBC, we have summarized…
Single Registration Number (SRN) assignment delayed
Compared to other European countries, many German economic operators have not yet been assigned their Single Registration Number (SRN), and there are reasons for this. The Federal Ministry of Health…