Medical Device PMCF Compliance and NSF Services

Vocabulary flashcards covering the Post-Market Clinical Follow-up (PMCF) process, regulatory guidance documents, and NSF medical device services.

NSF

A global provider of consulting, training, and auditing services for medical device, IVD, and combination product manufacturers that helps navigate regulations and implement sustainable quality systems.

PMCF

Post-Market Clinical Follow-up; a continuous process used to verify a medical device's safety and performance throughout its entire lifecycle after market entry.

MDR Annex XIV

The regulatory section that the strategy of Post-Market Clinical Follow-up (PMCF) must be in line with.

MDCG 2020-7

The guidance document utilized for aligning the strategy and planning of Post-Market Clinical Follow-up (PMCF) before market entry.

MDCG 2020-8

The guidance document used for the compilation and summary of results in a PMCF Evaluation Report (PMCFER).

Strategic Planning

The first step in the PMCF cycle which involves developing a PMCF plan before market entry, aligned with MDCG 2020-7.

Implementation of Activities

The second step in the PMCF cycle consisting of literature reviews, user surveys, and PMCF studies.

Evaluation and Reporting

The third step in the PMCF cycle where findings are summarized in a PMCF Evaluation Report (PMCFER).

Alignment and Update

The final step in the PMCF cycle where results are integrated into technical documentation and risk management.

PMCFER

Post-Market Clinical Follow-up Evaluation Report; a document that summarizes the findings of PMCF activities as per MDCG 2020-8.

Surveys

One of the most widely used and effective tools for generating post-market clinical data, especially when an equivalent device was initially considered in the clinical evaluation.

Notified Bodies

Regulatory stakeholders that are increasingly focusing on clinical data post-market launch and require facilitation of communication regarding PMCF work packages.

PMCF Activities Tailoring

The requirement that PMCF activities must be customized based on the device's risk class, intended use, and degree of innovation.