Medical Device Safety

We take care of everything for you: from notification requirements to vigilance and post-market surveillance (PMS)

For the US market the FDA Adverse Event Reporting is regulated in the CFR 820 Part 803. The risk management process ISO 14971 is fundamental for the safety of medical devices and reducing risk. We help you with investigator’s observations (FDA 483), changes in medical devices in the meaning of 21 CFR 807.81(a)(3) etc. 

For the European market, the directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC are  relevant. It includes the requirements for market surveillance as well as the revision of the clinical evaluation based on data obtained from post-market surveillance of the medical device.

According to the Medical Devices Safety Plan Ordinance (MPSV), manufacturers, operators, users, and distributors of a medical device are obligated to report incidents (product-related adverse events) without delay to the competent higher federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI), in order to prevent hazards (vigilance). A reportable incident is defined as a malfunction, failure, change in characteristics or performance,or improper labeling or instructions for the use of a medical device that has led, could have led, or could lead directly or indirectly to the death or serious deterioration of the health status of a patient, user, or other person. The BfArM assesses the risk of the incident. For this purpose, the manufacturer takes corrective measures in cooperation with the BfArM to eliminate the existing risk.

The European Medical Device Regulation (EU) 2017/745  requires that manufacturers systematically collect information on the use of a medical device after it has been placed on the European market and monitor their products (post-market surveillance [PMS]/vigilance). Manufacturers must update the technical documentation of their medical devices based on collected data and coordinate it with national vigilance and market surveillance authorities tp provide corrective or preventive actions (CAPA). The goal of this approach is to increase the safety and performance of medical devices.

Another medical device safety measure is post-market clinical follow-up (PMCF). It involves the clinical follow-up of a medical device after it has been placed on the market. This follow-up must be continual and is part of the clinical evaluation in the context of post-market surveillance (MDR, Annex XIV).

We would be happy to support you with medical device safety challenges. Just contact us!