MEDDEV 2_12-2_05-2004_Clinical Evaluation - Post Market Clin

MEDDEV 2_12-2_05-2004_Clinical Evaluation - Post Market Clinical Follow-up 标准

EUROPEAN COMMISSION DG ENTERPRISE Directorate G

Unit 4 - Pressure Equipment, Medical Devices, Metrology

MEDICAL DEVICES: Guidance document

MEDDEV 2.12-2

May 2004

GUIDELINES

ON POST MARKET CLINICAL FOLLOW-UP

The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the medical devices sector.

MEDDEV 2_12-2_05-2004_Clinical Evaluation - Post Market Clinical Follow-up 标准

May 18, 2004

POST MARKET CLINICAL FOLLOW-UP OF

MEDICAL DEVICES UNDER

THE MEDICAL DEVICES DIRECTIVES

Foreword : Rationale and Goals of PMCF

This document is intended to be a guide for manufacturers and notified bodies on how to carry out PMCF in order to fulfill post market surveillance obligation according to point 3. 1 of annex II, point 3. of annex IV, point 3 of annex V, point 3.1 of annex VI or point 4 of annex VII of medical device directive (add ref. AIMDD)

While clinical evidence is an essential element of the premarket conformity assessment process, it is important to recognize the limitations inherent to these premarket clinical investigations. The extent of the data that can be gathered in the premarket phase does not enable the manufacturer to detect infrequent complications or problems only apparent after widespread use, or /long term performance issues. As part of the manufacturer’s quality system, a program of appropriate post market surveillance is key to identifying and investigating risks associated with the use of medical devices placed on the market.

Manufacturers should have general systems in place to cover PMS as well as having a defined PMS strategy for each of their products/product ranges

Therefore, PMCF appears as a method of choice for this purpose. It will, for instance, enable patients' access to new therapies while establishing a review process for long term safety follow-up and detection of possible emergent risks that cannot be adequately detected by relying solely on pre-market clinical investigations (given the relatively short follow up required) or product experience /vigilance.

Implementation

Post market surveillance may include a number of strategies in addition to complaint handling and vigilance :

¾ active supervision by customer surveys, ¾ inquiries of users and patients, ¾ literature reviews,

¾ Post market Clinical Follow-up, etc..

Post market clinical follow-up (PMCF) through clinical studies and registries has a great importance among these strategies.

Post Market Clinical Follow-up (PMCF) should always be considered for devices where identification of possible emerging risks and the evaluation of long term safety and performance are critical. In identifying such emerging risk, the following criteria should be taken into account :

MEDDEV 2_12-2_05-2004_Clinical Evaluation - Post Market Clinical Follow-up 标准

innovation, when the design of the device, the material, the principles of operation, the technology, or the medical indication is new severity of the disease, sensitive target population risky anatomical location

well known risk from the literature

well known risk of similar marketed devices

Identification of an acceptable risk during pre-CE clinical evaluation, which should be monitored in a longer term and/or through a larger population.

Obvious discrepancy between the premarket follow up timescales and the expected life of the product

All PMCF should be planned. The PMCF plan can take the form of extended follow-up of patients enrolled in the pre-market trials, and / or a prospective study of a representative subset of patients after the device is placed on the market. It can also take the form of open registries. This plan will need to take into account :

Results of the clinical investigation including Adverse events identified Average life expectancy of the device The claims made by the manufacturer for the device Performances for which equivalence is claimed New information becoming available

PMCF, when carried out, must always be performed for the use of the product within its intended indications according to Instructions for use. National regulations on post market clinical studies must be taken into account.

The involved Notified Body should review the appropriateness of the manufacturer's general PMS procedures, incorporating PMCF, as relevant, as well their PMCF plan(s) and results for specific products as part of conformity assessment procedures and quality management system auditing

The follow up duration should take into account the average life expectancy of the product in its indication. Therefore, in case of a device subject to short term premarket follow up and intended to stay in the patient for its lifetime, a longer follow up will be required.

PMCF will not be required for products for which the long term clinical performance and safety is already known from previous use of the device. In the case the assessment of a product is performed through the concept of equivalence , PMCF should always be considered .

Post Market clinical Requirements (Risk based matrix)

The following table sets out a ‘triage approach’ …… 此处隐藏：5587字，全部文档内容请下载后查看。喜欢就下载吧 ……