- Mantra Systems
- Post Market Clinical Follow Up
Specialist Post Market Clinical Follow Up services for the EU MDR
At Mantra Systems, we have a team of expertly-trained medical doctors who are specialists at developing PMCF systems for the EU MDR. A PMCF framework is required for all medical devices regardless of class. Engaging the services of a PMCF expert who understands EU MDR requirements in detail can be a major step towards ensuring a successful MDR transition.
We offer a full PMCF design and implementation service. We tailor the design of PMCF systems to the unique needs of each client and product. Our PMCF products include:
- bespoke eCRF data collection systems
- writing of protocols and investigators brochures
- clinical site on-boarding
- results monitoring and reporting
We offer a free initial consultation service. Contact a member of our team to discuss your PMCF requirements.
What is Post Market Clinical Follow Up (PMCF)?
Post Market Clinical Follow Up (PMCF) is the process of proactively collecting and evaluating clinical data on the safety and performance of a CE-marked medical device. According to the MDR, Post Market Clinical Follow Up should be a continuous process that runs throughout the entire commercial lifetime of a medical device.
Post Market Clinical Follow Up has always been an important component of PMS but has gained much greater importance under the MDR than under the MDD. It is vital that all medical device manufacturers implement a PMCF system that will meet MDR requirements well before the MDR’s full implementation in May 2021.
Post Market Clinical Follow Up — an MDR guide
The implementation of the MDR - formally known as Medical Device Regulation 2017/745 - represents the most significant overhaul of medical device regulation in decades. One of the many changes it introduces is a greater focus on the documentation, methodological quality, and output of Post Market Clinical Follow Up systems.
According to Annex XIV Part B of the MDR, objectives of Post Market Clinical Follow Up are to collect and use clinical evidence in order to:
- Update the clinical evaluation
- Ensure continuing acceptability of benefit-risk profile
- Detect any emerging risks and previously unknown side-effects
- Confirm safety and performance of the medical device
- Identify any systematic misuse of the device
Annex XIV Part B requires that Post Market Clinical Follow Up systems are planned in advance with a detailed method documented in a technical document known as a PMCF Plan. Producing a PMCF plan requires extensive experience in designing clinical investigations in order to ensure that the chosen method is suited to meeting PMCF objectives. Choosing the wrong method can lead to expensive mistakes that are difficult to rectify retrospectively.
Mantra Systems offers a team of expertly-trained medical doctors who are specialists at designing PMCF systems for medical devices under the MDR. Avoid the costs associated with making PMCF mistakes and streamline your MDR transition by engaging one of our medical professionals. Contact a member of our team today to discuss your requirements.
How is Post Market Clinical Follow Up conducted under the MDR?
Post Market Clinical Follow Up under the MDR is intended to be a continuous, prospective clinical investigation process. Once a suitable clinical investigation method has been developed and documented in a PMCF Plan, data collection can begin in accordance with documented procedure.
Post Market Clinical Follow Up investigations must conform to MDR Annex XV requirements for clinical investigations, the GDPR, and Annex XIV Part B, as well as general requirements under Good Medical Practice and MEDDEV guidelines. Working with one of our medical experts is the best way to ensure that your PMCF system will meet all relevant requirements.
Once the Post Market Clinical Follow Up investigation is underway, results should be documented periodically (and at the end of the investigation) in a PMCF Evaluation Report. In turn, this report will form part of the Clinical Evaluation Report (CER) for the medical device.
What is the best format of clinical investigation for Post Market Clinical Follow Up?
The most appropriate choice of investigation format for Post Market Clinical Follow Up will depend upon the nature of the device and the existing clinical evidence portfolio. For many devices, the gold-standard is to develop a Medical Device Registry that can be designed specifically around the Post Market Clinical Follow Up needs of the subject device.
A well-designed product registry will collect data continuously and throughout the entire lifetime of the device, meeting MDR Post Market Clinical Follow Up requirements. Suitably designed, a product registry can also reduce variability between clinical sites, minimise opportunities for bias, and be a very cost-effective way to protect the regulatory status of a device both now and into the future.
Our medical professionals are experts at designing medical device product registries for MDR Post Market Clinical Follow Up. Contact a member of our team today to secure your medical device MDR transition.
Our team of specially-trained medical doctors provide expert EU MDR training and consulting services to medical device manufacturers.
Dr Paul Hercock Chief Executive Officer / Co-founder