The importance of post-market surveillance (PMS) has never been out of the buzz. Regulatory Authorities worldwide have established some stringent rules and regulations to efficiently monitor medical devices even after placing them on the market. Similarly, the European Union (EU) has emphasized PMS in its new regulations. Many requirements have been implied on the manufacturers, one of them being the Post-Market Surveillance Reports (PMSRs). Article 85 of EU Medical Device Regulations (MDR) 2017/745 and article 80 of EU In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 discuss PMSRs in detail.
PMSR is part of technical documentation, and to prepare the PMS reports, the manufacturers must follow Annex II under the EU MDR 2017/745 and IVDR 2017/746. The first and foremost part is to know that these reports are to be prepared by only Class I device manufacturers and Class A & B IVD manufacturers.
Your PMSRs will be efficient only when you have drawn out an accurate PMS plan. A PMS plan is quite an important element when it comes to the PMS system, as it is the paving path for the subsequent steps. The plan should cover all the objectives and requirements in accordance with the regulations. To give a gist, the PMSR must include results and analyses gathered to the corrective and preventive action taken against any complaints/feedback in the reported period. This report is expected to be updated when required or upon request of the competent authority.
Drafting PMSR is often tricky and may overlap with the Periodic Safety Update Reports (PSURs) in terms of understanding. The requirements for PMSRs and PSURs might seem similar, but the drafting is not. For instance, PSURs require additional information, such as vigilance reporting and the current status of the device. Also, the PSURs must be updated after a specific period of time. (Please be aware that the PSURs are not required to be drawn by Class I devices and Class A & B IVDs.)
As including accurate data is quite crucial, the following are the components that ideally should be covered in a typical PMSR :
- Product surveillance period
- Description of the data collection activities
- Information on the literature database
- Information on other similar devices
- Description of any serious incidents/non-serious incidents
- Description of feedback/complaints
- Analyzing the outcomes based on serious/non-serious incidents and feedback/complaints
- Corrective and preventive actions taken
Another aspect of drawing out the PMSRs is the articulation and compilation of the report, which requires precision and expertise in the subject. The job may seem to be simple and easy, but the preparation of these reports require expertise in the subject. As a result, several multinational companies tend to consult Regulatory experts in preparing this report. Medical writing is not perceived only as writing, formatting, and compiling documents but as a skill that involves technical competence, data analysis and interpretation, and effective presentation of the data. PMS data can indeed drive the fate of a device on the market.
Thus, being aware of the purpose of the post-market surveillance, having a proper understanding of the requirements, and devising appropriate strategies for the preparation of the documents is the key to successful PMSRs.
Do you require any support for PMSR preparation? Consult Freyr today!