PMS / PSUR / SSCP / PMCF
We’ve developed the experience needed to support medical device manufacturers at every step – from achieving compliance with global regulations to making processes more effective and efficient to improve business results.
Post Market Surveillance (PMS)
- Post marketing surveillance is the practice of monitoring the safety of a medical device after it has been released on the market and is an important part of the regulation.
- When done right, your PMS system can improve your device, provide better service to your users, and reduce the risk of adverse events before they happen. But with a numerous of regulatory obligations imminent over you, implementing a PMS system can be overwhelming.
- Our experts help you establish a regulatory complaint PMS plan and help you to understand the changing requirements. We also analyze the collected data for the betterment of your device and service in the market.
Periodic Safety Update Report (PSUR)
- A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medical device to regulatory authorities at defined time points post-authorization.
- PSUR is not new to the pharma world, it is a fairly new concept to medical devices.
- The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. The PSUR is intended for moderate and high-risk devices (Class IIa, IIb, III, implantable). It summarizes the results and conclusions from your PMS data. Additional information provides a summary of post market information, vigilance reporting, and current status of these devices on the market in the EU.
Summary of Safety and Clinical Performance (SSCP)
The Summary of Safety and Clinical Performance (SSCP) contains the information about safety and clinical performance of class III and implantable device. According to the article 32 of EU-MDR 2017/745, the SSCP shall be written in a way that it is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.
The SSCP will be an important source of information for intended users both healthcare professionals and patients.
The information in the SSCP should be sourced from design validation/verification reports, Post Marketing clinical report (PMS), Post Marketing Clinical Follow-up (PMCF), Clinical Evaluation Report and IFU.
Devices listed in MDR Annex XVI, and eligible for a SSCP, should always be considered as relevant for patient information.
The timing of the SSCP validation may depend on the class of device and the conformity assessment routes.
The SSCP shall be updated at least annually for Class III devices and once in a two year for class IIa implantable devices. The SSCP shall be updated, when PMCF & PSUR are updated for that particular devices.
Post Market Clinical Follow-up (PMCF)
- Post-market Clinical Follow-up (PMCF) is an important part of ongoing medical device regulatory compliance in the EU. PMCF can sometimes require you to conduct additional clinical investigations, called PMCF studies.
- In the new European regulatory context, PMCF is required in conjunction with post-market surveillance (PMS, see Annex III) and clinical evaluation reporting (CER) obligations, as well as with risk assessments and reassessments. PMCF studies previously addressed under MEDDEV 2.12-2 guidance are now included in the MDR and the need to conduct PMCF is furthermore reinforced and expanded upon in the MDR. Article XIV, part B of the Regulation defines PMCF as “...a systematic approach to obtain additional information on the performance and safety of a medical device…” that has already obtained CE marking when used in clinical settings. Manufacturers should develop PMCF plans including all PMCF activities for the expected lifecycle of their devices. Article XIV Part B section 6.2 of the MDR lays out specific components manufacturers should include in the PMCF plan.
- The results of PMCF under the MDR are an input into the PSUR, which also includes a re-evaluation of the risk-benefit profile of the device and the volume of sales. This sales volume puts into perspective the accuracy of the risk-benefit evaluation. We would advise having a clinical expert review and sign off on PSURs as this is a key document demonstrating compliance with the regulations and which also must be made public on the EUDAMED database.
- We develop the best PMCF plan and report formats for you to comply with the regulatory requirements. We analyse the data gathered by you in accordance with the regulations so that your device safety and performance can be established.