The UK has updat­ed its guid­ance on the UK Respon­si­ble Per­son. The doc­u­ment is applic­a­ble should the UK leave the EU with­out a deal and includes impor­tant details about the role and oblig­a­tions with the cor­re­spond­ing details.

Back­ground details on the UK Respon­si­ble Person

We have report­ed ear­li­er this year that – if the UK should leave the EU with­out a deal – man­u­fac­tur­ers who are not based in the UK, but aim­ing to place their devices on the UK mar­ket, will need a “UK Respon­si­ble Per­son”. Against this back­ground, the role of the EU Autho­rized Rep­re­sen­ta­tive won’t be applic­a­ble any­more in the UK. Vice ver­sa, this also means that UK based EU Autho­rized Rep­re­sen­ta­tives won’t be rec­og­nized in the remain­ing EU countries.

The British MHRA has now updat­ed its guid­ance on the role and respon­si­bil­i­ties of the UK Respon­si­ble Per­son. Basi­cal­ly, these are in line with the oblig­a­tions of an EU Autho­rized Rep­re­sen­ta­tive under the Reg­u­la­tions (EU) 2017/745 (MDR) and 2017/746 (IVDR).

What time­lines are involved and what are the cru­cial points?

Please find below a sum­ma­ry of the dead­lines man­u­fac­tur­ers must keep for the appoint­ment of a UK Respon­si­ble Per­son and the appoint­ment of a UK Respon­si­ble Person:

4 Month8 Month12 Month
Class IIIClass IIb non-implantable Class I
Class IIb implantable Class IIa med­ical devices Gen­er­al IVDs 
Active Implanta­blesIVD List B Class A IVDs 
IVD List A Self-test IVDs

In terms, of oblig­a­tions the MHRA states as follows:

Fur­ther­more, and that is also in line with the MDR and IVDR, the UK Respon­si­ble Per­son can be held liable against poten­tial claims.

For fur­ther details, please read the full post under

As always, please be assured that we will keep you updat­ed with any devel­op­ments in this regard.

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