Viewpoints
Writing Technical, Practical, and Theoretically interesting blogs
Guidance on the key changes of classification rules under the European Medical Devices Regulation
MDD was first published in 1993 to harmonize the laws relating to medical devices within the European Union. The MDR came into force on 25 May 2017. The amendment to the MDR was published in April 2020, amending the MDR Date of Application to 26 May 2021. From 26 May 2021, it became compulsory for the new devices to meet the requirements of the MDR to be placed in the European market. MDR...
Nov 25, 2021
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Can you continue your legacy medical device in EU MDR without adequate clinical data?
Implementation of MEDDEV 2.7-1 rev 4 and the transition from MDD to MDR has been a daunting task for manufacturers as the interpretation of the MDR standard is evolving since its release in 2016. There have been multiple challenges in understanding the EU MDR standard and its expectation on the clinical data requirements. The EC (European Commission) has listened to the concerns of the medical...
Sep 18, 2021
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The creation of a Design History File (DHF) Per 21 CFR 820.30
Introduction The Design History File (DHF) is a compilation of records that describes the design history of a finished device. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. The...
Jan 06, 2021
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The Performance Evaluation Report (PER) Per (EU) 2017/746
Purpose of Performance Evaluation Report (PER) The Performance Evaluation Report (PER) stands as a key aspect of the overall IVDR technical documentation. The purpose of the performance evaluation is to produce the clinical evidence that supports the manufacturer’s intended use. Performance evaluation of a device is a continuous process by which data are assessed and analyzed to...
Dec 28, 2020
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