Post Market Surveillance under Medical Device Directive (2017/745)
Regulation (EU) 2017/745 on medical devices (MDR) now has increased requirements on specific Post Market Surveillance (PMS) and Post-market clinical follow-up (PMCF) requirements. In this article, we look at the requirements for manufacturers.
Currently, manufacturers are required, under MDD (93/42/EEC) to comply with the requirements of PMS by having an up to date systematic procedure that is used to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action.
However, PMS and Post-market clinical follow-up activities under the new MDR now have more complex requirements and manufacturers will need to maintain more robust Post Market Surveillance procedures and perform more post-market clinical follow-up studies in order to meet the new MDR requirements.
The definition of Post Market Surveillance in the MDR (Article 2 Section 60) is what drives the PMS requirements and is defined as ‘all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.’
What are the requirements of Post Market Surveillance under MDR (2017/745)?
Under MDR, PMS contains both proactive and reactive elements and the Medical Device and manufacturers need to consider the following activities –
- Post Market Surveillance
- Risk Management
- Clinical Evaluation Plan and report
- Post-market surveillance plan and report
- Post-market clinical follow up (PMCF) plan and evaluation report
- Periodic Safety Update report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
The PMS and Periodic Safety report/Periodic Safety update report are required to be part of the Technical Documentation as specified in Annex II and III of MDR (2017/745) and, specific timelines regarding the update of the Periodic Safety Update Reports and their availability to Competent Authorities and Notified Bodies (depending on Classification of device) are detailed in the new MDR.
The increased requirements regarding Post-market clinical follow-up (PMCF), requires additional planning by manufacturers to adequately cover these in their PMS System. A specific PMCF plan is required for describing the activities. Post-market clinical follow-up is a continuous process that is part of clinical evaluation and forms a link from evidence collected in the premarket stage with Post Market data collected when the device is in regular use.
Integration into Quality Management System (QMS)
Manufacturers are required to incorporate PMS activities into their Quality Management System (QMS) – and these activities need to link with many elements of the QMS, including Design and Development, Management Review, etc.
It is also important to note the Post Market Surveillance, Risk Management and Clinical Evaluation all feed into each other.
What are the impacts to Medical Device Manufacturers?
There are many impacts to manufacturers, who in the past may have relied on their complaint and feedback systems to satisfy post market surveillance requirements.
Since the timeline for implementation is fast approaching (May 2020), manufacturers need to assemble resources and systems to perform the additional required tasks to satisfy MDR post market surveillance requirements.
These now include:
- requirements for resources for performing the collection and evaluation of
- data, and writing of reports
- the requirement for resources to perform documentation updates (risk, clinical evaluation, technical documentation)
- consideration of the impact on other economic operators
Note that the resources are not limited to Regulatory and may include Quality Assurance, Clinical affairs, Service, Sales and Marketing, Service and other Economic Operators.
Do you have the resources and systems in place to fulfill your obligations under the new MDR?
Our MDR team is dealing with many clients and helping them to prepare for the impending deadline. Talk to us today by calling 00353 52 61 76 706 or complete the form below.
Further MDR Reading from Acorn Regulatory
The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).
The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.
Get The Acorn Regulatory Medical Device Regulations Whitepaper
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2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2020
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During the course of our interactions with these clients there are many topics that are being raised time and again. Read more here.