Med-Info International expert information for the Medical Device industry Clinical data for EC certificate extension shall include: 1. A recent update of the “state of the art” review: 1.1 A documented, systematic literature review (not older than 6 months at time of submission to ensure it covers the most recent available data) according to the requirements as outlined in MEDDEV 2.7.1, including a protocol for identification, selection, collation, and review of relevant publications comprising search terms, data bases, criteria for inclusion/exclusion of particular references 1.1.1 to enable a thorough review of the current “state of the art” as described below. It is recommended to chose a two-stage approach with regard to the conduct of the literature search, i.e. start with a general literature search, which covers all indications to be treated with the device under assessment, followed by a concentrated search focusing on the device under assessment and competitor/comparable devices. 1.2 Review of the current “state of the art” is to be understood as a detailed discussion about limitations and benefits of: TÜV SÜD Product Service GmbH Clinical data requirements for EC certificate extension ll current therapeutic alternatives (including 1.2.1 A surgical/non-surgical/conventional/medicinal options) for the same specific indications/ medical conditions which shall be treated/ diagnosed through the assessed device 1.2.2 C ompetitor/comparable products used for the treatment the assessed device is indicated for 1.3 A justification whether, and if yes, why the assessed device can in future be regarded to be in compliance with the “state of the art“. 2. A thorough and critical evaluation of the available postmarket experience: 2.1 Marketing period 2.2 Number of devices sold 2.3 Number and type of complaints 2.4 Number and type of incidents 2.5 Corrective actions (if yes, which?) 2.6 P ostmarket clinical follow-up studies (in case data from a PMCF-Study are available the Study Plan and [Interim-] Study Report shall be provided as well as other applicable study documentation such as the vote of the Ethics Committee and approval letters issued by respective authorities) 2.7 Registries 2.8 L ong-term follow-up of pre-market clinical studies 2.9 A pure description of the postmarket experience might not be adequate. A critical evaluation of the data/information is needed with regard to acceptability for certain complications/complaints, and complication/complaint rates from a clinical point of view is needed. This is applicable not only for device-related complications/complaints but also for procedure-related complications/complaints. 4. A current version of the risk analysis, taking into account any issues related to clinical safety and side effects detected after market release. Your contact partner at TÜV SÜD Product Service can provide further information. Dr. Bassil Akra Phone: +49 89 5008-4421 Email: [email protected] If any item is not applicable, this shall be stated. TÜV SÜD Product Service GmbH, Medical and Health Services, Ridlerstr. 65, 80339 Munich www.tuev-sued.com/medinfo Med-Info October 2014/01 EU 3. A current version of the instructions for use, including indications/contraindications, risks/side effects and an update if required. The content of the instructions for use shall be in consistence with the complete technical documentation.
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