‍Healthcare-Related Issue:

The new EU Medical Device Regulation (MDR), which was scheduled to come fully into force in May 2020 but now looks likely to be postponed for 12 months due to the COVID pandemic, will substantially change the requirements on CE-Mark holders in terms of post marketing surveillance (PMS) and post marketing clinical follow-up (PMCF). Manufacturers will be obliged to put in place a PMS system which is structured to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime. This significantly raises the bar with respect to the situation under the EU’s previous Medical Device Directive in that surveillance must be pro-active, must comprise performance data from humans as well as quality and safety and must extend over the entire lifetime of the device. REGEN MED believes that the most advantageous approach to meeting and profiting by these new obligations is to align both the PMS and PMCF Plans with product Lifecycle Management and to integrate PMS and PMCF data collection within a single platform, such as Regen Med’s inCytes™.

Project Design

The end-goal of any REGEN MED Project is not to consult; it is to provide a turnkey, evidence-based solution to generating the proper evidence from product users, patients and other pertinent economic operators in order to allow the Client to meet and profit by the new PMS and PMCF requirements.

Achieving this result requires, as the initial step, a focused interaction with one or more representatives of the Client to coordinate with REGEN MED on the Project Design and its implementation. This Working Group will then:

1. Select the products or product families to be included in the project.

2. Review Lifecycle Management strategies for these products.

3. Develop plans to integrate the organization’s PMS and PMCF Plans into these strategies, comprising indications of milestones and descriptions of potential acceptance criteria and laying-out a detailed and adequately justified time schedule.

4. Identify the portions of these plans that would require proper collection of evidence from product users, patients or other economic operators and its aggregation and analysis. These longitudinal data collection projects would be supplemented with periodic screening of scientific literature and of other sources of clinical data including specific evaluation of the clinical data relating to equivalent or similar devices.

5. Determine the specific data points relevant to each PMS/PMCF. These would include:

a. Clinical data points such as patient-reported outcome measures,

b. Safety-related data points aimed at both identifying previously unknown side-effects and monitoring previously identified side-effects and at ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

c. User-experience data points focused on product quality and functionality experience gained by users or other economic operators with the objective of identifying possible systematic misuse or off-label use of the device.

6. Develop the protocols implementing the foregoing datapoints and set them up within REGEN MED’s inCytes platform.

7. Develop the Client Report templates presenting the aggregated evidence generated. These report templates would be designed to facilitate the Client in documenting the results in both PMS and PMCF reports that become part of the Clinical Evaluation report and other technical documentation.

8. Develop Patient Report and User Report templates.

9. Identify third-party constituencies to involve in the Project, whether in design or reporting. Examples of such constituencies may include, for example, institutions that could conduct periodic literature review.

Timing and Implementation

Project Design Steps 1 – 5: Two to four working weeks.

Project Design Steps 6 – 10: Two to four working weeks. Some steps may be executed in parallel with prior steps.

REGEN MED to provide all:

· Scientific and clinical expertise relating to the evidence generation projects. (REGEN MED can also work with Client’s domain experts as desired.)

· Engagement with regulatory agencies, notified bodies, economic operators (e.g. distributors, etc), physician users and other constituencies identified by Client. Examples of engagement includes initial explanation of nature and benefits of project, associated education and training and ongoing communications.

· Within REGEN MED’s inCytes platform: coding, GDPR and other security, registry structure, automated communications, data correlation functions. Technical integration with existing systems.

· All tools for pre-, peri- and post-procedural evidence collection, aggregation and analysis.

· Project management, including operational, financial and other.

· KPI reports to all Client stakeholders.

· Establishment of, and/or integration with existing, communications channels, and the development of professional, Project-specific content for access through such channels.

Other Considerations

It is the goal of REGEN MED to show concrete results as soon as possible in addressing the specific issue underlying a given Project. The Project Design phase requires the active involvement of Client representatives, but the implementation phase can largely be undertaken by REGEN MED.

Budget depends on the final Project Design. To a substantial extent, REGEN MED prices its services to correspond to achievement of concrete KPI’s reflecting that design.

Resource Links

The new EU Medical Device Regulation: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en

European Parliament decides to postpone new requirements for medical devices: https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices