Obelis to hold EROMED seminar at MEDICA 2016

European Regulation of Medical Devices

Obelis Group will hold an EROMED seminar at the MEDICA trade show, taking place from the 14th November till 17th November in Messe Düsseldorf, in Germany. The seminar, which is entirely free of charge, will be conducted at the Obelis booth (Hall 17, Stand D59), every day at 11 am and 3 pm. It will focus on the new proposal on EU legislation on Medical Devices and its impact on the compliance path and the CE marking process.

What is EROMED?

The European Medical Devices Seminar (EROMED) is a series of workshops organized all over the world by Obelis and its international offices. It was created in 2007 to inform the international industry about the European legislative requirements on medical devices. EROMED seminars focus on promoting the compliance of medical devices in Europe by educating medical device manufacturers on the DOs and DON’Ts when introducing these products to the European market.

What is in the agenda for EROMED 2016?

The seminar held at MEDICA will focus largely on the new proposal on the EU Regulations on Medical Devices and In-Vitro Diagnostics Devices, which is expected to come into force in 2017. The speakers will outline the final provisions and discuss the new requirements brought by the new regulations. The seminar will also present other relevant regulatory topics, such as the Free Sales Certificate, Incident Reporting or Technical File. Below you can find the detailed list of presentations (all lasting approx. 15 min):

  1. Medical Device Regulation – FINAL NEW Provisions (requirements & compliance)
  2. In-Vitro Regulation – FINAL NEW Provisions (requirements & compliance)
  3. Liability on defective devices
  4. Technical File (Elements & Guidelines)
  5. Incident Reporting & Vigilance (Guidelines to incident reporting)
  6. Free Sales Certificates by EU Authority
  7. EU National Device Registrations
  8. EUDAMED & UDI

If you wish to know more about the EROMED seminar at MEDICA 2016, please feel free to contact us or visit our website.

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