The UK has left the EU and is thus not an inte­grat­ed part of the EU reg­u­la­to­ry sys­tem any­more. Although man­u­fac­tur­ers of med­ical devices may place CE marked devices on the Great Britain mar­ket until June 30, 2024, the appoint­ment of an EU Autho­rized Rep­re­sen­ta­tive is not suf­fi­cient any­more. Instead, a UK Respon­si­ble Per­son must be appoint­ed to reg­is­ter the cor­re­spond­ing devices locally.

Switzerland’s reg­u­la­to­ry sys­tem will remain aligned with the EU. How­ev­er, the mutu­al recog­ni­tion agree­ment between Switzer­land and the EU expired in 2021. As such, non-Swiss man­u­fac­tur­ers require a Switzer­land-based Autho­rized Rep­re­sen­ta­tive before plac­ing the prod­ucts on that market.

At the same time, man­u­fac­tur­ers from Great Britain or Switzer­land need an EU-based Autho­rized Rep­re­sen­ta­tive if they want to sell prod­ucts into the EU or EEA respectively.

No mat­ter what kind of ser­vice you require in the con­text above, mdi Europa may assist you in ful­fill­ing the cor­re­spond­ing reg­u­la­to­ry requirements.

Should you require fur­ther details, please don’t hes­i­tate to get in touch.