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The EUropean DAtabase on MEdical Devices (EUDAMED) is a database to collect and publish information on medical devices and in-vitro-diagnostica. EUDAMED has six modules: Actors registration; UDI/Devices registration; Notified Bodies and Certificates; Clinical Investigations and performance studies; Vigilance and post-market surveillance; Market ...
It is possible to convert air crew licences issued by other ICAO member states ("third countries") to an EASA licence. The applicant must have a valid third country licence and valid medical certificate. They must also hold a valid EASA medical certificate. They must pass all fourteen EASA theoretical exams.
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
The manufacturer should register their products through their Italian distributor who is not only familiar with the language and local regulations but also has responsibility if he is the "c) other individual responsible for trading medical devices as under article 13, paragraph 2 of legislative decree no. 46 of 24 February 1997" as mentioned in the official form here:
For UK Part-FCL licences, a UK Part-Med certificate is required. UK Part-Med was inherited from EASA Part-Med. For the LAPL, an LAPL medical certificate can be issued by some GPs. [23] For the PPL, a Class 2 Medical is required, which can be issued by an AeroMedical Examiner (AME). For the CPL, a Class 1 Medical is required.
The child and a 41-year-old woman were taken to Weill Cornell Medical Center while a third victim, 49, went to Bellevue Hospital. The three other victims — ages 19, 37 and 49 — refused medical ...
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
So, that’s something worth considering based on your own fitness level and medical history. Khurshid noted he didn’t find any association between weekend warriors and an increased risk of ...