5. Technical File & DoC

Technical File

The purpose of the Technical file is to enable the manufacturer to prove that his product complies with the “General Safety and Performance Requirements (GSPR)

File that documents device description, performance, development and manufacturing information and documents compliance with the MDR/IVDR. The file should contain all documentation (or references) pertinent to that device ie. a stand-alone file for each product, or can be combined for a product family

Technical documentation must be such as to enable enforcement authorities to assess the conformity of the device/product to the requirements of the Regulations

It must cover the design, manufacture and operation of the device/product

Most importantly, it forms the basis of your safety case!

Possible Structure

Device Description and product Specification

Labelling and Operator Manual/Instructions for Use

Design and Manufacturing Information

Essential Requirements Checklist

Risk Management File

Verification and Validation Testing, Including:

• Clinical Evaluation ( Literature review/clinical data/Clinical Trail)

• Benefit/Risk Evaluation

• Test Reports

Declaration of Conformity

Technical file format

Must be “controlled”

Must contain all the required information

Can be a traditional paper file

Information may be stored electronically

• Hyperlinks can be used to link documents

• Needs to be backed-up

Must be easy to produce all documentation at short notice

Must be easy to maintain and must be kept up to date

• You can’t just do it then forget about it!

Devices must be designed and manufactured so as:

Not to compromise patients’ clinical conditions or safety

• - to have acceptable risk/benefit ratio

• - to afford high level of protection of health and safety

To eliminate/reduce risk

To provide relevant information

• - to perform as claimed

• - to assure traceability of values assigned to calibrators

To have characteristics and performance applicable during the lifetime of the device

To retain performance after storage and transport

Why???

Legal Requirement for the legal manufacturer to hold technical documentation relating to safety and efficacy of the product

Applicable to all classification of devices

Must be available at all times for regulatory authorities

Must be kept up to date

Must be retained for the lifetime of the device, and at least 5 years from the date of last production of the product.

Declaration of Conformity

The Declaration of Conformity is a one-page document on which you, as the manufacturer of a medical device, "declare" your "conformity" with the GSPR of the European Medical Device Regualations. Annex 4 of the Regualation spells out the need for an EC Declaration of Conformity.

All manufacturers of medical devices whether you self-declare or require Notified Body intervention-must prepare a Declaration of Conformity

Legally binding document that should be signed by a senior company officer.

Think of it as a sworn statement in which you declare in public that you have met all of the regulatory obligations required to market your products in Europe.

If you manufacture a Class I (Sterile or Measuring), IIa, IIb or III device, you will need to be audited by a Notified Body to obtain what is commonly called a "CE Certificate."

This registration audit is part of the Conformity Assessment process. The CE certificate is issued by your chosen Notified Body (examples: TUV, BSI, Intertek, SGS, UL, etc.) after successful completion of your registration audit.

Once all compliance requirements have been met and the CE certificate has been issued, you can then prepare a Declaration of Conformity .

Often, people confuse the CE certificate with the Declaration of Conformity.

Each CE certificate comes with a certificate number that you may choose to place on the Declaration of Conformity.

Also, you will need to list the name of your Notified Body (if applicable) and its corresponding four-digit identification number.

Some Notified Bodies have been requiring companies to have a completed and signed Declaration of Conformity as part of their Technical File during the review process, which in most cases happens before or during the on-site registration audit.

Since the Declaration of Conformity is a legally binding document, it should only be signed once you have met all the GSPR of the Regulation, which includes a successful on-site inspection by a Notified Body.

If this becomes an issue for your company, provide your Notified Body with a signed copy but clearly identify it with a stamp that says "SAMPLE."

The Declaration of Conformity must be printed on your company letterhead and should include the following pieces of information:

• Device trade name and model number

• Device classification (Class and Rule)

• Your company name and address

• Name of quality management representative

• Notified Body name and ID number (if applicable)

• CE certificate number (if applicable)

• Date CE Marking was first applied

• Authorized Representative contact information

• Route to compliance Standards applied (optional)

• Name and signature of company officer

This list may vary depending on your Notified Body (if applicable), and the document's format is not dictated by the regulatory authorities. The content is the most important, as the information is declaring to the reviewer that your products are fully compliant with the GSPR for Medical Devices.

With regard to listing applied standards on the Declaration of Conformity, opinions vary. Some say that inclusion of the standards is required; others say it is not.