Device: 
Basic UDI-DI:

Manufacturer:  (from here on abbreviated to )
Manufacturer SRN: 

Name and function Signature Date Author Review Release

Version Date Name Function Change

1. Device Description and Specification

See technical documentation .

DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

1.1. General Description of the Device, its Variants and its Intended Purpose

See technical documentation .

1.1.1. Basic Manufacturer Information

Name and Address of the Manufacturer

PRRC Contact Information:

Authorised Representative Contact Information:

SRN: 

Importer Information:

CE Certificate:

of .

EU QMS Certificate:

of .

QMS Certificate:

of .

1.1.2. Overview of Devices

Please note that if your product has a large number of variants, that have all the same name you have to adjust the following table.

Device Name REF Number UDI-DI REF Number of your device UDI-DI of the device/packaging unit REF Number of your device UDI-DI of the device/packaging unit

1.1.3. Trade Names

1.1.4. Intended Purpose

The intended purpose of the device includes the intended purpose statement, indications, contraindications and warnings, the intended patient group, medical conditions to be diagnosed/treated/monitored, side effects and user profile and environment.

1.1.4.1.  Intended Purpose Statement

1.1.4.2. Indications

1.1.4.3. Contraindications

1.1.4.4.  Patient Group

1.1.4.5.  Patient Population

1.1.4.6.  Intended User

1.1.4.7. Use Environment

1.1.4.8. Medical Purpose

1.1.4.9. Medical Discipline

1.1.4.10. Medical Purpose

1.1.4.11. Medical Conditions

1.1.4.12. Anatomical Site

1.1.4.13. Invasiveness

1.1.4.14. Side Effects

1.1.4.15.  Warnings

1.1.4.16. Precautions

1.1.5. Codes for Product Identification

1.1.6. Technical Specifications

Electrical Safety

See technical documentation .

Electromagnetic Compatibility (EMC)

See technical documentation .

MRI Safety

See technical documentation .

Features and Technical and Clinical Performance

Technical Drawings and Dimensions

Add the technical drawings including the dimensions of your device to the folder 1.1. A short description might be added here.

See technical documentation .

1.1.7. Variants, Components, Configurations and Accessories

The device is described in the table under 1.1.2. It is possible that you have very complex variants structure. If further information is necessary to describe the device, please add this in the following.

Otherwise state: "The products are sold in different sizes and with different components, see overview under 2.1.2."

1.1.7.1. Variants

1.1.7.2. Components

1.1.7.3. Configurations

1.1.7.4.  Accessories

1.1.8. Software Exact Software Version

Rationale for software as a medical device:

Software version:

Software Safety Class:

Rationale for Software Safety Class:

List of software modules and their medical purpose:

1.1.9. Explanations of new Characteristics, New Intended Purposes and New Indications

1.2. UDI

1.2.1. Basic UDI-DIs

This Technical Documentation covers following basic UDI-DIs: 

All devices with this Basic UDI-DI have following in common:

• same intended purpose

• same risk classification

• same essential design (for example different surgical scissor)

• same manufacturing characteristics (some NBs use the MDT/MDS codes to clarify this point)

Please also state where you have generate the Basic UDI-DI (GS1, HIBCC). Please also explain if necessary how you grouped devices under one Basic UDI-DIs.

1.2.2. UDI-DIs and UDI-PIs

Please explain if necessary how you generate your UDI-DI and UDI-PI.

Device Packaging level Packaging unit UDI-DI UDI-PI Direct marking on the device / primary packaging How many devices on this level

See technical documentation .

1.3. Classification

Device class:

Classification rule:

Conformity Assessment Procedure:

Other Regulation:

See technical documentation .

1.4. Declaration of Conformity (DoC)

The DoC shall be written according to Annex IV MDR 2017/745 (EU). For initial certifications (e.g. MDR) the DoC has to be filed in draft status.

See technical documentation .

1.5. Description of the Principles of Operation of the Device

See technical documentation .

1.5.1. Principle of Operation

1.5.2. Mode of Action

1.5.3. Key Functional Elements

1.6. Summary of Safety and Clinical Performance

If applicable, a SSCP has to be created ().

Not applicable. A report according to Art. 32 MDR on safety and clinical performance is only necessary for implantable devices and for class III devices except custom-made or investigational devices.

See technical documentation .

1.7. Raw Materials, Components, Packaging Materials

See technical documentation .

1.7.1. Overview of Raw Materials of Components / Parts

MSDS and CoAs can be found in . Please make sure that they are complete and up-to-date.

1.7.2. Specifications of Packaging Materials

SDS and CoAs can be found in . Please make sure that they are complete and up-to-date.

Short summary of the packaging process ():

1.7.3. Identification of Substances that Come into Direct or Indirect Contact with the Human Body

The  comes directly /does not come into contact with the human body.

1.8. Declaration on Particular Substances

See technical documentation .

1.8.1. Use of CMR, Endocrine-Disruptors, Phthalates

Applicability of CMR, Endocrine-Disruptors, Phthalates

Formal Statement

1.8.2. Use of Nanomaterials

Applicability of Nanomaterials

1.8.3. Use of Medicinal Substances

Applicability of Medicinal Product

Formal Statement

1.8.4. Use of Tissues or Cells of Human Origin

Applicability of Tissues or Cells of Human Origin

Formal Statement

1.8.5. Use of Tissues or Cells of Animal Origin

Applicability of Tissues or Cells of Animal Origin

Formal Statement

1.8.6. Use of Tissues or Cells of Other Biological Origin

Applicability of Tissues or Cells of Other Biological Origin

Formal Statement

1.9. Previous and Similar Generations

See technical documentation .

1.9.1. Overview of the Previous Generations of the Device Produced by the Manufacturer

1.9.2. Overview of Similar Devices Available on the Market in the European Union or on International Markets

2. Labelling and Instructions for Use

The is labelled in accordance with Annex I 22.2, GSPR (General Safety and Performance Requirements), of EU Regulation 2017/745, including the requirements of  and the symbols in accordance with .

An overview of labelling, IFU (instructions for use) and promotional materials is given in the following table.

2.1. Label

An overview of the labelling process can be found in . The labelling specifications are defined in document .

The labelling process () is summarized as follows: .

Please ensure that a flowchart/short summary of the labelling process is available in the appropriate QM document.

An overview of the labels can be found under 2. in the table "Overview of information materials".

See technical documentation .

2.2. IFU

In special cases an IFU is not mandatory. If the device falls under this exemption, please add a rationale here, such as: Instructions for use are usually required. The device is only used by qualified specialists. The use of the medical devices is known to these medical experts and therefore a completely safe use of the products is guaranteed. For this reason, instructions for use are not required as they fall under the exemption of MDR Annex I, 23.1 d.

If the IFU is integrated into the label, add a statement such as:

The instructions for use for the device are integrated into the label (see paragraph XXX).

The instructions for use contain all the information required for the application of the product in accordance with the GSPR (General Safety and Performance Requirements) in accordance with Annex I 23.4 of EU Regulation 2017/7451.

If sterile packaging is applicable add the following sentence: Additionally the information on the packaging which maintains the sterile condition of the device is in accordance with Annex I 23.3 of EU Regulation 2017/745. 

An overview of the IFUs can be found under 2. in the table "Overview of information materials". The IFU specifications are defined in document .

See technical documentation .

2.3. Promotional Materials

An overview of the promotional materials can be found under 2. in the table "Overview of information materials".

See technical documentation .

3. Design and Manufacturing Information

See technical documentation .

3.1. Description of the Design

See technical documentation .

3.1.1. Description of the Design Process

In this section please add the applied Design Process, the phases (e.g. milestones) that were applied during in the design of the device and a summary of the results of these phases.

Please make sure that you have available all relevant design documentation.

OR

If the device did not have a standardized development process, please add the following sentence:

The device was developed in YYYY. (Please insert the year. If unknown, please insert the year in which your device was first sold.) At that time there was no development process according to a standard (such as EN ISO 13485). Therefore point 3.1.1 is not applicable.

3.1.2. Identification of all Sites where Design Processes were Performed (e.g. Outsourced Design Units, Research Sites, etc.)

3.2. Description of the Manufacturing

3.2.1. Comprehensible Description of Manufacturing

This section should include the production process flowchart, master batch records, three batch records as examples, identification of all entities, including suppliers and subcontractors, where design and manufacturing activities are carried out.

See technical documentation .

3.2.2. Manufacturing Sites and Manufacturing Steps

During processing the following additives and processing processing aids are used and/or potential process contaminants or machine contaminants need to be considered:

3.2.3. Information on Specific Processes and their Validation

The validation of specific manufacturing processes, if applicable, can be found in technical documentation .

3.2.4. Information on Controlled Conditions under which Certain Manufacturing Steps Take Place

The validation of controlled conditions, if applicable, can be found in technical documentation . I

3.2.5. Installation and Commission of the Device

3.3. Description of Quality Control

See technical documentation .

3.4. Outsourced Processes, Subcontractors

See technical documentation .

3.4.1. Overview of outsourced Processes, Name and Address of the executing Companies

3.4.2. Evidence of Qualification of Subcontractors

Evidence of qualification of subcontractors like certificates and evidence of accreditation can be found in the technical documentation .

3.4.3. Quality Assurance Agreements with Subcontractors for outsourced Production Steps and in the case of sterile Devices for Outsourcing of Packaging and/or Sterilisation

Not applicable. / See technical documentation .

4. General Safety and Performance Requirements GSPR

4.1. Systematic Evidence of Compliance with the General Safety and Performance Requirements

See technical documentation .

4.2. List of Applied Standards and Common Specifications

See technical documentation .

A current list of applied standards including the applied issue and, if applicable, indication of which parts of the standards have not been applied.

5. Benefit-Risk Analysis and Risk Management

See technical documentation .

The following points must be submitted from the current risk management file covering all life cycles:

5.1. Risk Management Plan

As part of the risk management process, the product is undergoing a regular risk assessment by , which includes information from the subsequent phases of production in accordance with  (market observation, complaints, new scientific findings, standards, etc.).

A risk management plan according to  is available for the device ().

See technical documentation .

5.2. Risk Analysis

The Risk Analysis includes risk control measures ().

See technical documentation .

5.3. Risk Management Report

The Risk Management Report () includes the evaluation of residual risks and the evaluation of the benefit-risk ratio.

An actual risk management report is available that fully implements the requirements of .

Please find last versions and reasons for updates in the document history of the report and state them here.

Result: Based on the benefit-risk assessment, all possible risks are acceptable i.e. no risk-reducing measures are required.

See technical documentation .

6. Verification and Validation of the Product

See technical documentation .

6.1. Biocompatibility

All components and materials which (can) have direct or indirect contact with the patient or user must be considered.

See technical documentation .

Please add the summary of the biocompatibility report.

6.2. Physical, Chemical and Microbiological Tests

Evidence of characterisation and preclinical suitability of the devices with regard to applicable test parameters (e.g. physical composition, chemical characterisation and purity of raw materials and finished product, microbiological condition of the finished device, etc.).

Please add a short summary of the the tests.

See technical documentation .

6.3. Electrical Safety and EMC

Not applicable. Please add a short summary of the the tests if this point is applicable to your product.

See technical documentation .

6.4. Other Pre-Clinical Tests

Not applicable. If there are any other preclinical tests not addressed under 6.1 to 6.5, please add a short summary of the conducted tests here.

See technical documentation .

6.5. Stability Including Shelf Life

Shelf life:

Lifetime:

Stability (see following table).

See technical documentation .

6.6. Usability

See technical documentation .

6.7. Clinical Evaluation

See technical documentation .

6.8. Special Substances

See technical documentation .

6.8.1. CMR or Endocrine-Disrupting Activity

See technical documentation .

List of CMR or Endocrine-Disrupting Substances

Analysis and Estimation of Potential Patient or User Exposure

Analysis of Possible Alternative Substances, Materials or Designs

Justification against Material-Related Design Changes

Applicability of Phthalates

6.8.2. Nanomaterials

See technical documentation .

6.8.3. Medicinal Substances

See technical documentation .

Justification for the Use of Medicinal Substances

Information and Identification of Medicinal Substances

6.8.3.1. Medicinal Components

6.8.3.2. Incorporation of Medicinal Products

6.8.3.3. Quantitative and Qualitative Composition

6.8.4. Tissues or Cells of Human Origin

See technical documentation .

Justification for the Use of Human Tissue Material

Identification of Human Origin Material

Number of treatments possible:

Route of administration:

Description of sourcing, processing, preservation, testing and handling of human origin materials or their derivates:

6.8.5. Tissues or Cells of Animal Origin

See technical documentation .

Justification for the Use of Animal Tissue Material

Identification of Animal Origin Material

Number of treatments possible:

Route of administration:

Transmissible Spongiform Encephalopathies (TSE) risk estimation:

Description of the avoidance of cross contamination during manufacturing:

6.8.6. Biological Materials or Organisms

See technical documentation .

Tissues or cells of other biological origin other than human or animal.

Justification for Material Safety:

Identification of non-viable biological substances utilised:

Methods for identification of microbial production strain and for strain maintenance in master cell bank, working cell bank and production cell bank should be defined:

Description of preservation, testing and handling of those substances:

Safety regarding viruses and other transmissible agents using appropriate methods of sourcing:

Consideration of fermentation and production residuals:

6.9. Substances that are Intended to be Introduced into the Human Body

See technical documentation .

6.9.1. Substances to be Introduced into the Human Body

6.9.2. Identification of Substances that are Intended to be Introduced into the Human Body

6.10. Sterility

The device is .

If the device is non-sterile, please delete the following statement and table.

The sterilization method is .

The validation of the sterile packaging process can be found in .

6.11. Measurement Function

See technical documentation .

6.12. Combination with Other Devices

Combination with other devices:

Restrictions for use:

See technical documentation .

6.13. Hygienic (Re-)Processing of Devices

See technical documentation .

6.13.1. Reprocessing Activities

Cleaning and Disinfection

Maintenance and Functioning

Reprocessing Activities Described in the IFU

Sterilization Done as Reprocessing Activity

Sterilisation parameters:

6.13.2. Validation of Reprocessing Activities

See technical documentation for:

• Validation of reprocessing activities

• Validation of sterilisation processes specified in the IFU

• Evidence of numbers of specified reprocessing cycles

• Evidence of maintenance and functioning controls specified in the IFU

6.14. Software Verification and Validation

Not applicable. Please add a short summary of the the tests if this point is applicable to your product.

See technical documentation .

7. Technical Documentation on Post-Market Surveillance

7.1. Post-Market Surveillance Plan (PMS Plan)

According to Article 84 MDR a post-market surveillance plan shall be part of the technical documentation.

See technical documentation .

7.2. Post-Market Clinical Follow-Up Plan (PMCF Plan)

According to Article 61 and Annex XIV MDR Part B a post-market clinical follow-up plan shall be part of the technical documentation.

See technical documentation .

7.3. Post-market Surveillance Report (PMS Report) OR Periodic Safety Update Report (PSUR)

If you have a class I device please use this section and delete the one below.

According to Article 86 MDR a periodic safety update report (PSUR) shall be prepared by manufacturers of class IIa, class IIb and class III devices.

This section is not applicable because the is a  device.

See technical documentation .

If you have a class IIa/IIb/III device please use this section and delete the one above.

According to Article 85 MDR a post-market surveillance report shall be prepared by the manufacturer summarising the results and conclusions of the analyses of the post-market surveillance data together with a rationale and description of any preventive and corrective actions taken for all class I devices.

This section is not applicable because the is a  device.

See technical documentation .

7.4. Post-Market Clinical Follow-Up Report (PMCF Report)

According to Article 61 and Annex XIV MDR Part B a post-market clinical follow-up report shall be part of the technical documentation. The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.

See technical documentation .