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#Tecnical data pcc135w painnt update#
#Tecnical data pcc135w painnt verification#

#Tecnical data pcc135w painnt update#

The relevant data and information gathered through PMS, as well as the lessons learned from any implemented preventive and/or corrective action, should be used to update the technical documentation, such as those relating to risk assessment and clinical evaluation and, furthermore, should also serve the purpose of transparency 4. In the view of the regulators, manufacturers should play an active role during the post-market phase by systematically and actively gather information from post-market experience with their devices, in order to update their technical documentation and cooperate in the vigilance and market surveillance activities. The total number of documents to be included into the technical documentation remains broadly the same the only difference being the inclusion of a PMS plan, andĪ Periodic Safety Update Report (PSUR, for devices greater than Class I, Article 86) or a PMS report (for devices of Class I, Article 85) 3. Is there a major difference from the technical file submitted before MDR? Post- Market Surveillance (PMS) plan and report.Pre-clinical and clinical data, such as test results, Clinical Evaluation Report (CER) and Post-Market Clinical Follow-Up (PMCF) evaluation plan.

#Tecnical data pcc135w painnt verification#

Product verification and validation report, and other relevant documentation.

Benefit-risk analysis and risk management file.

Documentation demonstrating compliance with all general safety and performance requirements and all relevant harmonised and non-harmonised standards.

Design and manufacturing information, such as design schematics and data about all sites, where design and manufacturing activities are performed.

Instructions for use in all the languages accepted in the Member States where the medical device is foreseen to be sold.

Complete labelling and packaging information, including single-unit sales and transport packaging in case of specific management conditions.

Device description and specification, including all the variants and accessories.

What does a medical device technical file include?Īccording to Annex II of the EU MDR 2017/745, a medical device technical file should include the following sections 5: Importantly, non-EU manufacturers must keep the file with an authorized representative in the EU for consult whenever requested – as such, keep a controlled version of the file always on hand. It should be made in English, or in an official language of an EU Member state and, be made available on request for the whole life cycle of the medical device (5 years for low risk, and 16 years for high-risk medical devices).

The MDR Technical File Template must be submitted to a Notified Body (NB) or a Competent Authority for review and approval. Does the medical device technical file need to be approved? Regardless of a device class, or its intended use, design, or even the safety history of the device, the manufacturer must have – and keep up-to-date – this technical documentation, in order to demonstrate the compliance with general safety and performance requirements of the legislation.

What is a medical device technical file?Ī medical device technical file is a summary document prepared by the manufacturer in a clear, well-organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the specific device. Catarina Carrão, freelance medical writer on Kolabtree, provides an overview of what a medical device technical file is and what it should contain.