Post-market surveillance and vigilance

The legislation on medical devices, IVD devices and NMI are a set of product safety regulations where one of the main goals is to ensure an acceptable risk-benefit balance and to prevent incidents and avoidable risks. The requirements and provisions placed on the devices and their manufacturers provides a framework to achieve that goal.

Before a device or NMI is placed on the market, CE-marked devices as well as other devices, the manufacturer shall have performed a comprehensive risk assessment and clinical evaluation to identify any risks and taken measures to eliminate and reduce risks as far as possible.

The risk assessment and clinical evaluation shall continue throughout the entire life cycle of the devices or NMI. The legislation requires the manufacturers to perform systematic post-market surveillance (PMS) for as long as the devices or NMI are in use.

Despite the best effort to prevent risks and incidents, they will still occur in the use phase of the life cycle of the devices and NMI. Therefore, the manufacturer shall have a system to handle any received reports on incidents and complaints, assess them and take corrective and/or preventive actions to prevent further risks and incidents.

PMS and vigilance (PMSV) shall be handled within a quality management system (QMS). This QMS shall, among other things, contain procedures for

• reporting of serious incidents to the competent authorities
• taking necessary actions to minimize any unacceptable risks with devices on the market and in practical use
• taking necessary actions to ensure the proper usability, safety and performance of the devices
• inform the user of any newly identified and unforeseen risks
• recall and withdraw devices from the market
• plan and procedure for continuous and systematic surveillance of device safety by e.g. trend monitoring and updates of clinical evaluation and summary of safety and clinical performance (SSCP)
• plan and procedures for periodic reporting of PMSV (including periodic safety udate reports (PSUR) for devices in class IIa, IIb and III (MDR) and class C and D (IVDR))
• plan and procedure for post-market clinical follow-up (PMCF).

Further information on specific tasks within PMS and vigilance is available on separate web pages.

Device categories with different regulations

The requirements on PMS and Viglance is affected by the implementation of MDR and IVDR. The devices are commonly divided into three categories:

• ”Regulation devices”: Devices that are placed on the market fully according to the requirements in MDR/IVDR.
• ”Legacy devices”: Devices that are placed on the market according to the transtional provisions in MDR/IVDR after the respective date of application, 26 May 2021 (MDR) and 26 May 2022 (IVDR).
• ”Old devices”: Devices that are placed on the market before the respective date of application for MDR and IVDR. I.e., medical devices placed on the market according to legislation based on MDD/AIMDD before 26 May 2021 and IVD devices placed on the market according to legislation based on IVDD before 26 May 2022.

There are different requirements on PMS and vigilance for the different categories. Specific information can be found on the webpages on specific topics.

• “Regulation devices” and “Legacy devices” are subject to the requirements on PMS and vigilance in MDR/VDR.
• ”Old devices” are subject to the requirements on PMS and vigilance in the legislation based on MDD/AIMDD/IVDD which is clarified in the guidance document MEDDEV 2.12/1.

Custom-made devices

Custom-made medical devices are subject to the same requirements on PMS and vigilance as CE-marked devices.

• Custom-made device that left the manufacturing stage (i.e. placed on the market) from 26 May 2021 are subject to the requirements on PMS and vigilance in the MDR.
• Custom-made device that left the manufacturing stage (i.e. placed on the market) before 26 May 2021 are subject to the requirements on PMS and vigilance in the legislation based on MDD.

Nationella medicintekniska informationssystem (NMI)

Nationella medicintekniska informationssystem (NMI) are not medical devices, but their characterics and use are closely related to medical devices. They are subject to a separate national legislation, currently HSLF-FS 2022:42. The current legislation entered into force 1 August 2022 and is harmonised with MDR and is a substantial revision from the previous legislation (LVFS 2014:7) based on the MDD.

The legislation included requirements on PMS and vigilance for NMI placed on the market as follows:

• NMI placed on the market or put into service according to HSLF-FS 2022:42 are subject to the requirements on PMS and vigilance in HSLF-FS 2022:42.
• NMI placed on the market or put into service according to LVFS 2014:7 are subject to the requirements on PMS and vigilance in LVFS 2003:11 (Swedish implementation of MDD). Some further information in Swedish, can be found in bilaga 2 in the guidance document for NMI. However, the transitional provisions in HSLF-FS 2022:42 states that also these NMI preferably should comply with the requirements on PMS and vigilance in HSLF-FS 2022:42 after 1 August 2022.

Guidance documents

The requirements on PMS and vigilance in MDR and IVDR are rather detailed and should in most cases be directly applicable in practice. However, guidance documents have been developed to clarify certain aspects.

In practice, the requirements on PMS and vigilance in the legislation based on MDD/AIMMD/IVDD are mostly covered in the guidance MEDDEV 2.12/1. A large part of the principles laid down in MEDDEV 2.12/1 has been integrated into MDR/IVDR.

For certain device categories (e.g. insulin pumps, coronary stents and breast implants) specific guidance documents has been developed to implement best practice. They are referred to as Device Specific vigilance guidance (DSVG).