Guid­ance on Per­son Respon­si­ble for Reg­u­la­to­ry Compliance

The Med­ical Device Coor­di­na­tion Group (MDCG) has recent­ly pub­lished a use­ful guid­ance on the “Per­son Respon­si­ble for Reg­u­la­to­ry Com­pli­ance” (PRRC) accord­ing to arti­cle 15 of the MDR and IVDR. There are no big sur­pris­es, but it still answers some ques­tions that are not direct­ly answered in the cor­re­spond­ing Regulations.

More specif­i­cal­ly, the doc­u­ment clar­i­fies that:

• in terms of qual­i­fi­ca­tion evi­dence “any qual­i­fi­ca­tion acquired out­side the EU, includ­ing any uni­ver­si­ty diplo­mas or cer­tifi­cates, should have been rec­og­nized by an EU Mem­ber State”, 
• pro­fes­sion­al expe­ri­ence should be “relat­ed to the EU require­ments in the field”,
• the PRRC must be an employ­ee of the com­pa­ny (except for small and micro manufacturers),
• enti­ties with sev­er­al legal man­u­fac­tur­ers must have a PRRC for each legal manufacturer,
• an indi­vid­ual may not be the PRRC for  a man­u­fac­tur­er and its autho­rized rep­re­sen­ta­tive at the same time.

There are more specifics, for exam­ple how to inter­pret the roles and respon­si­bil­i­ties of the PRRC as stat­ed in the MDR and IVDR. Please click here to down­load the orig­i­nal guid­ance document.

Source: MDCG guid­ance on the per­son respon­si­ble for reg­u­la­to­ry compliance

We pro­vide addi­tion­al infor­ma­tion and down­loads on this subject:

Guid­ance Doc­u­ments in our Com­plete Down­load Sec­tion regard­ing MDR
Guid­ance Doc­u­ments in our Com­plete Down­load Sec­tion regard­ing IVDR

If you require fur­ther infor­ma­tion on this top­ic, please don’t hes­i­tate to get in touch with our team.