The three medical device guidelines have formulated regulatory and protective measures for medical devices after they are marketed. In the form of regulations, the EU can establish a management system for the reporting, collection, evaluation, and announcement of social adverse behavior events, and strive to ensure that once medical devices in my country have some adverse events after they are on the market, they can minimize the harm, reduce the recurrence of similar accidents, Microfluidic Chip Manufacturerand make patients Or the user's safety education and healthy development can be protected.

The Medical Device Directive (EC-Directive 93/42/EEC) stipulates in Article 10:

1. Member States are responsible for recording and handling adverse events after listing.

2. Medical staff or medical institutions should report adverse events in a timely manner and notify the manufacturer or its European representative at the same time.

3. After analyzing the incident, the member states should determine whether to activate the protection clause.

In the in vitro diagnostic medical device directive (EC-Directive 98/79/EEC), the concept of a vigilance system (Vigilance System) is proposed. It is established in the form of regulations required by enterprises, competent authorities, notified bodies, users and other A system in which relevant personnel participate together to achieve the purpose of protecting patients, users, and related personnel through the means of reporting adverse events and evaluating all reported events and publishing relevant information.

There are also protection clauses in the Medical Device Directive:

The Medical Device Directive (EC-Directive 93/42/EEC) stipulates in Article 8:

1. If a member state finds that medical devices that have been sold or put into use do not meet the basic requirements,vital signs monitor the unified standards are improperly used, or the standards themselves are not sufficient, the European Commission should also report that the installation, maintenance and use of medical devices for the intended purpose endangers patients, The reasons and measures taken for the safety and health of users or related personnel.

2. The European Commission should listen to the opinions of the party being processed as soon as possible, and then make a decision:

If deemed appropriate, notify the Member States immediately.

If the handling is improper, the decision-making country and the person being handled shall be notified immediately.

If it is deemed to be a standard issue, it shall be submitted to the Standards Technical Regulations Committee for processing.

3. For medical devices with a CE mark that does not meet the requirements, member states should take measures to stop them and notify the European Commission and other member states.

related articles:

EU Medical Device Regulatory Model

The basic requirements and harmonized standards of the EU Medical Device Directive

The eight special requirements for medical equipment include: