New Guid­ance for the UK Respon­si­ble Per­son Published

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 Month	8 Month	12 Month
Class III	Class IIb non-implantable	Class I
Class IIb implantable	Class IIa med­ical devices	Gen­er­al IVDs
Active Implanta­bles	IVD List B	Class A IVDs
IVD List A	Self-test IVDs

In terms, of oblig­a­tions the MHRA states as follows:

• ensure that the dec­la­ra­tion of con­for­mi­ty and tech­ni­cal doc­u­men­ta­tion have been drawn up and, where applic­a­ble, that an appro­pri­ate con­for­mi­ty assess­ment pro­ce­dure has been car­ried out by the manufacturer
• keep avail­able a copy of the tech­ni­cal doc­u­men­ta­tion, a copy of the dec­la­ra­tion of con­for­mi­ty and, if applic­a­ble, a copy of the rel­e­vant cer­tifi­cate, includ­ing any amend­ments and sup­ple­ments for inspec­tion by the MHRA
• in response to a request from the MHRA, pro­vide the MHRA with all the infor­ma­tion and doc­u­men­ta­tion nec­es­sary to demon­strate the con­for­mi­ty of a device
• for­ward to the man­u­fac­tur­er any request by the MHRA for sam­ples, or access to a device, and ensure that the MHRA receives the sam­ples or has been giv­en access to the device
• coop­er­ate with the MHRA on any pre­ven­tive or cor­rec­tive action tak­en to elim­i­nate or, if that is not pos­si­ble, mit­i­gate the risks posed by devices
• imme­di­ate­ly inform the man­u­fac­tur­er about com­plaints and reports from health­care pro­fes­sion­als, patients and users about sus­pect­ed inci­dents relat­ed to a device for which they have been designated 
• ter­mi­nate the legal rela­tion­ship with the man­u­fac­tur­er if the man­u­fac­tur­er acts con­trary to its oblig­a­tions under these Reg­u­la­tions and inform the MHRA and, if applic­a­ble, the rel­e­vant noti­fied body of that termination

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 https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario.

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

If you are inter­est­ed in Brex­it you might also find the fol­low­ing arti­cles informative

• MHRA draft recog­ni­tion pol­i­cy for inter­na­tion­al approvals
• UK-approved body capac­i­ty increas­es but not for IVDs
• Great Britain’s plan to accept med­ical devices reg­is­tered abroad
• UK MHRA gives CE marked devices new tran­si­tion deadlines
• UK updat­ed guid­ance will reflect EU extensions