Support 200404
Device:
Basic UDI-DI:
Manufacturer:
Manufacturer SRN:
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.
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.
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).