IVDR Whitepaper

Introduction

What is IVD?

In-Vitro Diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

Before placing device in market, the manufacturer shall undertake Confirmatory assessment of device as given in Annexes IX to XI of EU IVDR 2017/746.

Classification

IVDR are classified in 4 classes.

Class A- Highly critical data, e.g. for transfusion medicine or determination of life-threatening or infectious diseases.

Class B- critical data, e.g. human genetic testing, determining levels of medicinal products, detecting infectious or inherited diseases in the embryo or fetus. Most self-tests (performed by the patients) fall within class C.

Class C- less critical parameters such as glucose or leukocytes. Class B is also the default class for all parameters which do not fall within the scope of any of the stated rules.

Class D- uncritical devices such as washing solutions or general culture media are classified as class A.

IVDR divides in In vitro diagnostic products into further categories:

• Devices for near-patient testing.
• Devices for self-testing.
• Companion diagnostic devices which are essential for the safe and effective use of a corresponding medicinal product. An example would be a genetic test verifying whether a cytostatic is effective.

Submission and content of technical documentation

Submission should contain:

• Cover Letter.
• DTechnical documentation.

Cover Letter

• Certificate number reference (If known).
• Type of review of documents ( i.e. New product, any design change) .
• Description including classification ((According to Annex VIII), Conformity assessment routes.
• And explanation of the
  • What has been submitted and how it demonstrates compliance.
• For change to existing certification.

What is affected (packaging, material change, life, etc.).

What is not affected (along with appropriate justification).

Technical Documentation

If device was previously certified under IVDD, then also you have to submit complete technical documentation.

For submissions in the context of scope extensions or substantial change approvals, as far as is practical, submissions should be standalone and not refer to previous submissions as evidence of compliance. The reviewer must be able to assess the documentation in the context of the intended submission and confirm it is still relevant within this context.

Verification of performance

For Class D devices and others, if requested, devices will be required for testing by an EU Reference Laboratory (EURL) to verify performance. Scientific Opinion of the EURL will be sought for the verification of performance claims made by the Manufacturer (Article 48 (5)). A positive opinion will be needed for certification of the device.

Information Required to Support Verification of Manufactured Product (Class D Only)

Prior to the verification of performance, the EURL (European Union Reference Laboratory) must first establish the success criteria. This will be conducted in parallel to the Technical Documentation review.The information required are :

• Product batches needs to be sent to the laboratory to establish criteria.
• And the batches must meets manufacturers QC Specifications and having same configurations as the technical documents submitted. And must have clear labelled name, lot number, expiration date, and IFU of the device.
• Ongoing batch release may require along with the kit following document needs to be submit by manufacturer.
• Final QC testing / release certificate.
• Labelling ( device send along with the packaging box containing IFU of the device).

Document format

• Manufacturer must submit all the technical documents in English language.
• All the documents submit by the manufacturer should be in PDF/ word format.
• Documents should be submit in separate folder .
• Documents should be bookmarked to ensure ease of navigation.

Optical Character Recognition (Searchable Format)

• Manufacturers scanning directly from a printed page should utilize Optical Character Recognition (OCR) so that as much of the resultant PDF file is as searchable
  as possible.
• No searchable submission should be OCR conversion at the time of submission.

Bookmarks

• Bookmarks are requested to aid in locating major sections of the technical documents. As a minimum, sections in IVDR Annex II “Technical Documentation” should be bookmarked.
• Sometimes random bookmarks based on document headings and subheadings are created when documents are converted to PDF format. These bookmarks should be edited to provide clear document references and to remove excessive, unnecessary or confusing bookmarks.
• Clear organization and easy navigation will make it easier to find documents and will therefore reduce overall time required for the review.

Pagination

• Each page of the submission should have a separate, sequential page number. Each page should have a unique number irrespective of the total number of pages in the Technical Documentation.
• PDF files are automatically numbered. Where possible, please always provide reference to the pagination in the PDF file as this will aid the Technical Documentation review. Where this is not possible, please make it clear what the page number refers to.
• Pagination is not mandatory but it is useful for easier searching of documents.

Signatures

• Signatures are mandatory on the documents.
• Signature paged should be scanned and added in the documents.
• All protocols/reports which require approval (as per the legislative requirements & Manufacturer’s own procedures and policies), except for the Declaration of Conformity, must have undergone those requisite approvals and be submitted with evidence of those approvals (typically through dated and signed reports, signed protocols, or evidence of approval in an electronic system etc).

Submission

• First filled application form along with the documents required.
• After accepting the form notified body will assign the reviewer.
• The conformity assessment of the Technical Documentation review can begin upon receipt of a signed quote together with required application documentation (per Annex IX for initial submissions).
• The conformity assessment of the Technical Documentation review can begin upon receipt of a signed quote together with required application documentation (per Annex IX for initial submissions) .