Prac­ti­cal PMCF strate­gies and plans

Overview

The Med­ical Devices Reg­u­la­tion (MDR) presents stricter require­ments for med­ical device man­u­fac­tur­ers, empha­siz­ing the crit­i­cal impor­tance of patient safe­ty and a clin­i­cal evi­dence-based approach to ben­e­fit-risk determination.

Help­ful guide­lines, such as MDCG 2020-7 and MDCG 2020-8, pro­vide struc­tured tem­plates for these essen­tial documents.

Under the MDR, post-mar­ket clin­i­cal fol­low-up (PMCF) has become an inte­gral part of the post-mar­ket sur­veil­lance (PMS) process for all devices, offer­ing a wide range of meth­ods for gath­er­ing clin­i­cal data. Com­pli­ance starts from the qual­i­ty man­age­ment sys­tem, and man­u­fac­tur­ers play a key role in ensur­ing the gen­er­a­tion of the PMCF plan and report.

Help­ful guide­lines, such as MDCG 2020-7 and MDCG 2020-8, pro­vide struc­tured tem­plates for these essen­tial documents.

PMCF plan

The PMCF plan is a cru­cial part of the tech­ni­cal doc­u­men­ta­tion for med­ical devices. It out­lines the activ­i­ties and time­lines for PMCF.

It is essen­tial to care­ful­ly con­sid­er the needs of the device and devel­op an effi­cient strat­e­gy to address them. Over-com­mit­ting or being too light in the PMCF plan can lead to com­pli­ance issues and delays.

PMCF activ­i­ties for dif­fer­ent devices

PMCF activ­i­ties may vary depend­ing on the sta­tus of devices:

• New Devices: PMCF activ­i­ties may need adjust­ments based on clin­i­cal data from a piv­otal study.
• Lega­cy Devices: PMCF activ­i­ties may be required to close any gaps pri­or to CE-mark­ing under the MDR. For devices that have already been mar­ket­ed, well-designed sur­veys may be the opti­mal and cost-effec­tive approach for PMCF.

Man­u­fac­tur­ers have addi­tion­al time to gen­er­ate the nec­es­sary PMCF due to extend­ed dead­lines for tran­si­tion­ing devices to the MDR. 

Chal­lenges for spe­cial­ized devices

There are also chal­lenges in con­duct­ing PMCF for high­ly spe­cial­ized devices, such as those intend­ed for:

• Rare con­di­tions or diseases
• Spe­cif­ic patient pop­u­la­tions where devices are used infrequently.

The guid­ance MDCG 2024-10 acknowl­edges the dif­fi­cul­ties in gath­er­ing clin­i­cal data and sug­gests that spe­cif­ic PMCF activ­i­ties may help address lim­i­ta­tions in clin­i­cal data for these orphan devices. It also empha­sizes the impor­tance of a well-planned PMCF strat­e­gy to meet reg­u­la­to­ry require­ments cost-effectively.

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Suf­fi­cient clin­i­cal evi­dence under the MDR for class I lega­cy devices
• Prac­ti­cal advice for set­ting up an MDR and IVDR com­pli­ant PMS Plan
• Urgent­ly Required MDR Guid­ance Doc­u­ments for Clin­i­cal Eval­u­a­tions and PMCF Published