Transitional period until December 31, 2020.

As a result of Brexit from February 1, 2020 the transitional period was extended up to December 31, 2020, quite a wide time span, in which the United Kingdom and EU will negotiate the future relations.
During such transitional period Great Britain will remain aligned to the EU concerning the trade and business rules:

  • The regulations now in place will be valid and applicable;
  • The EU right will continue to be applied in the United Kingdom and in its inside;
  • The EU will treat the United Kingdom as a member state, except for the participation to the Institutions and to the EU Governance structures.  

Consequently, the operators of Medical Devices and in vitro diagnostic Medical Devices sector can continue to behave as they do now, in accordance with current European law, until the end of 2020.
The new regulation will enter into force from January 1,2021.

Pending the conclusion of agreements, the tension on what could be the main normative innovations remains high:

  • UK Responsible Person (UKRP): the manufacturer of an EU Country that wants to merchandise in the United Kingdom will have to name a person that assumes all the responsibilities of the manufacturer concerning the Medical Devices registration. All Medical Devices, the Ivd and the custom-made devices, will have to be registered at MHRA before being placed on the British market.
  • Any Ministerial registrations.

Thema staff follows the updating to offer in short times complete strategic counseling services for what concerns the relevant new regulations as a result of Brexit.