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European Union (EU) Essential Requirements Checklist and the Australian Principles Checklist for Medical Devices-Significance in a technical file and differences

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Apr 11 2017
Categories : Uncategorized
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Author : admin

Introduction

The Australian Essential Principles Checklist (AEPC) is a list of 15 general and specific rules set by the Therapeutic and Good Administration (TGA). These, assist and simplify the assessment of a device’s efficacy and safety based on information provided in the associated technical file.
AEPC 15 apply specifically to IVD products. The AEPC justifies the compliance of the devices to the standards chosen by the manufacturer and the reason if not applicable.
The European Essential Requirements Checklist (EUERC) is the European analogue of the AEPC, it has the sameoverall purpose with very similar verbiage in most circumstances but it includes only 13 principles. The EUERC is now formalised in standard ISO/TR 16142.
Both are auditable documents when technical files are reviewed by relevant authorities for products of all risk classifications.

The role and importance of AEPC and EUERC

The AEPC and the EUERC can be considered as the first referenced documents in your technical file built up. In a well prepared technical file, both checklists are used as referenced content lists of your dossier with links to updatable sections of that dossier.
This is largely depended on the manner documents are managed and controlled. The checklist and related clausesbecome the first step towards the elaboration of the technical file by the manufacturer, based on the type of device, its design, manufacture, function, composition, use, claims, and clinical evaluation.
Moreover, it assists the manufacturer to choose the appropriate standard or related documentation to follow and which, in most circumstances makes the checklist an acceptable referenced document.
Particular caution for submissions for Australia as the only acceptable assessable document is the AEPC. Where the applicant uses the EUERC for Australia then an add-on document must be included to show that requirements meeting the gaps between the two checklists have been identified and met.
An additional point of caution nevertheless of the presumption that meeting a standard means meeting the associated clause of the essential R/P checklist. This is not true as the intent ultimately is to ensure a correct validated methodology approach has been taken to substantiate the safety and efficacy of the product.

Key Differences between EP and ER

The following table shows where EP and ER are different and what the related specificities are

Conclusion

All elements of theAEPC and the EUERCneed to be assessed when compiling the checklist. Even though both are very similar, there are several subtle differences that should be consideredat the initial stage of technical file preparation.
Where medical device applications are submitted for either Australia and Europe, a gap analysis between both checklists at the onset will ensure the completeness of the document to the relevant authority.
RQSolutions can supply ready-made templates addressing combined elements of both AEPC and the EUERC. These can be made available on request to admin@rqsolutions.com.au


RQSolutions (www.rqsolutions.com.au) services the global Therapeutic Goods Industry, with over 35 years’ expertise, in Sponsorship, TGA Registrations, PLAC related Government Reimbursement,ISO13485 based Quality Management and document management optimisation.We are based in Australia and a heartbeat away from our colleagues at the TGA. Let us share with you, the various available options to register your Medical Devices in Australia. We look forward to hearing from you toadmin@rqsolutions.com.au

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