Discover Thema services to reach your objectives in time!
The regulation of Medical Devices has changed for a long time but the date of application of the MDR, namely 26/05/2021, is very close. Moreover, since 1 January 2021, with Brexit, Great Britain has implemented its requirements for the marketing of devices on the territory, first of all (but not only) the appointment of the UKRP.
At this point we want you to ask a question: what do you need right now? What are the resources that you would need to get serenely to achieve your regulatory compliance and sales goals?
The answers to this question could be many and to help you identify what you need, we want to inform you about the most requested services to Thema in this period of preparation for the MDR.
THEMA services needed to reach your objectives
In order to have a clear view of what the CE certification entails, according to MDR it is necessary to provide for activities of Regulatory Strategy and understanding the impact of the regulation on the Quality System and on the Technical Documentation, planning the necessary steps. Do you really think there is still time considering that your device enjoys a Period of Grace? Attention! It is not like that; starting from 26/05/2021 some requirements of the MDR will have to be implemented, and they will be checked by Certification Bodies, Notified Bodies and Competent Authorities.
Ask for consulting.
From December 1, 2020 it is available the 1° Module (Actor Registration Module). EU and non-EU Manufacturers, Authorised Representatives, system Manufacturers and Importers of Medical Devices and In Vitro Diagnostic Medical Devices can already register with EUDAMED and provide the information necessary to obtain a single registration number (SRN).
Our Thema experts can take care of your registration. Contact us!
Following BREXIT and in accordance with the new regulations in force since January 1, 2021, if the Manufacturer is based outside the United Kingdom, it must appoint a UKRP with its registered office in the United Kingdom in order to continue of start placing Medical Devices on the UK market. This new figure acts on behalf of the Manufacturer to perform specific tasks, such as the registration of Medical Devices at the Regulatory Authority MHRA.
Do you want to register and market your devices in the UK?
Choose Thema as your UK Responsible Person!
MDR (EU) 2017/745 adaptation: do you prefer to act mainly on your own?
Discover MDR Emergency Kit!
Contact us for further information!