Device:
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Basic UDI-DI:
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Manufacturer:
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Manufacturer SRN:
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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
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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
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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."
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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
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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
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1.6. Summary of Safety and Clinical Performance
If applicable, a SSCP has to be created (
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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.
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1.7.1. Overview of Raw Materials of Components / Parts
MSDS and CoAs can be found in
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1.7.2. Specifications of Packaging Materials
SDS and CoAs can be found in
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Short summary of the packaging process (
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The
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The labelling process (
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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
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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.
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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.
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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.
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Evidence of qualification of subcontractors like certificates and evidence of accreditation can be found in the technical documentation
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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
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4. General Safety and Performance Requirements GSPR
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See technical documentation
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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
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The following points must be submitted from the current risk management file covering all life cycles:
5.1. Risk Management Plan
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The Risk Management Report (
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An actual risk management report is available that fully implements the requirements of
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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
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Multiexcerpt include macro macro_uuid 26bcf667-c05b-4081-9160-7066a2b49973 name 6.1.1 Biological Evaluation Plan templateData eJyLjgUAARUAuQ== page Documents TD and QMS (ADA) addpanel false Multiexcerpt include macro macro_uuid 26bcf667-c05b-4081-9160-7066a2b49973 name 6.1.2 Biological Literature Search templateData eJyLjgUAARUAuQ== page Documents TD and QMS (ADA) addpanel false Multiexcerpt include macro macro_uuid 26bcf667-c05b-4081-9160-7066a2b49973 name 6.1.3 Biological Literature Search Protocol templateData eJyLjgUAARUAuQ== page Documents TD and QMS (ADA) addpanel false Multiexcerpt include macro macro_uuid 26bcf667-c05b-4081-9160-7066a2b49973 name 6.1.4 Biological Evaluation Report templateData eJyLjgUAARUAuQ== page Documents TD and QMS (ADA) addpanel false
Please add the summary of the biocompatibility report.
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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
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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
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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
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The device is
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If the device is non-sterile, please delete the following statement and table.
The sterilization method is
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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
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See technical documentation
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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.
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See technical documentation
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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.
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