Germany: Announcement from the Federal Ministry of Health regarding the transition until EUDAMED is available
On 26th May 2021, the Federal Ministry of Health issued the announcement regarding the transition to full EUDAMED functionality, as required in accordance with Section 97 MPDG; it was published on 28th May 2021 in the Federal Gazette.Learn more
Germany: MPI becomes DMIDS
The previous national database of medical devices, the German Medical Devices Information System (MPI), has, as of the date of application of the MDR, been renamed the German Medical Devices Information and Database System (DMIDS). Its function (and some of the terminology within the database) will initially remain predominantly unchanged and will be adjusted gradually.
EU: New guidance document for the "clinical evaluation assessment report template"
The MDCG has issued a guidance document with a template for the evaluation report issued by notified bodies regarding the clinical evaluation of manufacturers (MDCG 2020-13).
Although the template is primarily intended for notified bodies, it also details the minimum content specified for the clinical evaluation tests; manufacturers should take into account this information when performing clinical evaluations and creating corresponding plans and reports.
EU: Explanations regarding the incident form
The EU has published explanatory information regarding the new incident form in a "Questions and Answers" document.
EU: Update to the incident report forms
The EU has updated the incident report forms to version 7.2.1. The new forms and a description of the changes can be downloaded from MEDDEV guidance on Directive 93/42/EEC under MEDDEV 2.12.
EU: Guidance document on reporting from clinical investigations
The EU has published two guidance documents on reporting serious unwanted events in clinical studies as per the MDR, taking into account the assumed delay to the availability of the EUDAMED database. MDCG 2020-10/1 describes the basis for the report; MDCG 2020-10/2 is a template for a summary report.
EU: Additional notified bodies for the MDR
The EU has announced the 14th notified body for the new EU Regulation on Medical Devices 2017/745 (MDR) – the Swedish organisation Intertek Medical Notified Body AB.
EU: Postponement of the MDR announced in the Official Journal
The change to the EU Regulation on Medical Devices 2017/745 (MDR) relating to the postponement of the date of application by one year to May 2021 has been published in the Official Journal of the EU. The corresponding change applies with immediate effect.