PMCF is a continuous process that updates the clinical evaluation in the manufacturer’s post-market surveillance plan. The PMCF involves the collection and evaluation of the clinical data from the use on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
It is performed pursuant to a document method laid down in the PMCF plan.
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
- Confirming the safety and performance of the device throughout its expected lifetime,
- Identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
- Identifying and analysing emergent risks on the basis of factual evidence,
- Ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I – EU MDR 2017/745, and
- Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
The PMCF plan includes:
- the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
- the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
- a rationale for the appropriateness of the methods and procedures
- a reference to the relevant parts of the clinical evaluation report and to the risk management referred
- the specific objectives to be addressed by the PMCF
- an evaluation of the clinical data relating to equivalent or similar devices
- reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and
- a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation and the technical documentation.
The PMCF plan includes:
Landmark Research provides the following services to assist with PMCF:
- Survey plan development
- Development of questionnaires
- Scoping of the survey
- Determine suitable endpoints and acceptance criteria
- Determine feasibility of survey execution
- Sample size calculations and statistical justification
- Delivery of electronic survey
- Data analysis and reporting
Regulatory Strategy Development:
- Network Partners Experienced Regulatory Project Leads offer a comprehensive approach for developing your regulatory strategy
- Develop Regulatory strategy and Regulatory Project Plan
- Identify Project deliverables
- Define marketing strategy support through international registration planning
- Risk assessment and management
- Quality management systems implementation
- Regulatory strategy and compliance
- Product Lifecycle Management
EU MDR Support:
- Writing Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs)
- Writing pre-market CERs
- Updating existing CERs
- Writing pre-market CERs
- Writing Post Market Clinical Follow Up (PMCF) Plans & PMCF Report
Clinical evaluators for various therapeutics areas
- State-of-the-art justification
- Literature searches, weighting and summarization
- Design & Development Documentation
- Post Market Surveillance Plan & Report
- Periodic Safety Update Report
- Notified Body Query resolution support
Post-Market Regulatory Support:
Our team utilizes its medical device industry experience and executes regulatory post-market strategies in a cost-effective and compliant manner.
- Annual Reports
- Change Assessments and Supplements
- Recall Strategy and Support
- MDR Reporting
- Regulatory Support
- Consent decrees
- Liaison between company and regulatory agencies