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The purpose of this document is to outline the processes and responsibilities for the certification of a medical device product. The document provides guidelines for the creation of a basic UDI-DI, UDI-DI and UDI-PI, creation of the technical file, the conformity assessment procedures, creation of the declaration of conformity, and the release of the product to the market in both the EU and the US.
This document describes the process of readying a medical device product, including both software and hardware, for certification in the European Union (EU) and the United States (US). This includes the creation of the technical file, the declaration of conformity, UDI creation and management, conformity assessment procedures, and product release.
To prepare for certification of a new or updated medical device product, the technical documentation must be completed. The technical documentation should contain the following information at a minimum according to Annex II of MDR 2017/745 and FDA requirements:
The technical documentation should be compiled into a technical file for the device. The technical file also meets the requirements for the medical device file as described in ISO 13485:2016, Section 4.2.3. The technical file can contain all the information provided or can contain summaries of the information and appropriate references to the other documents that are relevant.
MDR ClassificationThe MDR classification of the device intended to be released onto the market should be confirmed prior to the conformity assessment process according to Annex VIII of MDR 2017/745. Additionally, an MDR code for the device according to MDCG 2019-14 should be determined. The MDR classification and MDR code will determine the conformity assessment route for the device.
`For Class I devices, a conformity assessment by a Notified Body is not required to place the device on the market, unless it is sterile (Is), has a measuring function (Im), or is a reusable surgical instrument (Ir). Once the quality team has determined that the technical documentation is complete, the declaration of conformity can be drafted and signed by management to confirm that all necessary regulatory requirements have been met to conform with requirements for the device to be on the market in the EU.
For Class IIa, IIb, and III devices, a conformity assessment is required. The conformity assessment is performed by a Notified Body, which is an organization designated by the European Union to assess the conformity of medical devices with the requirements of the MDR. A certification of the quality management system and the technical documentation is required for the device to be placed on the market. The specific conformity assessment route depends on the device class (Annex IX, X, or XI).`
The quality team will be responsible for selecting a notified body that is appropriate for the certification of the device. The appropriate MDR code should be determined for the device and reviewed against the qualifications for identified notified bodies to determine the appropriate notified bodies available for selection. The quality team will initiate contact with the notified bodies that accept the device's MDR code and determine their capacity for review including timelines and costs.
A notified body will be selected and a contract will be signed with the notified body for the conformity assessment. The quality team will provide the notified body with the technical documentation and any other necessary information for the conformity assessment.
The quality team will be responsible for preparing the documentation for the notified body and being the lead contact in communication with the conformity assessment procedures, unless otherwise specified by another organizational member. The subject matter experts and process owners shall be notified of the intent for conformity assessment and provided with the necessary information and training to support the process, as needed.
The quality team will be the lead contact for the notified body during the conformity assessment procedures. Requests from the notified body will be organized by the quality team who will coordinate with the subject matter experts and process owners to provide the necessary information and documentation to the notified body. The quality team will be responsible for ensuring that the notified body has all the necessary information to complete the conformity assessment.
Should there be non-conformities or corrective and/or preventive actions required due to the conformity assessment findings, the quality team will be responsible for coordinating the necessary actions to address the non-conformities.
`For Class I devices (non Is, Im, Ir), the declaration of conformity can be drafted when it has been determined that the technical documentation is completed and the device meets the requirements for the MDR. The declaration of conformity should be signed by management to confirm that the device meets the requirements for the MDR and can be placed on the market in the EU.
For Class Is, Im, Ir, IIa, IIb, and III devices, the declaration of conformity can be drafted after the conformity assessment has been completed by the notified body (where applicable). The declaration of conformity should be signed by management to confirm that the device meets the requirements for the MDR and can be placed on the market in the EU.`
The declaration of conformity should include the following information according to Annex IV of MDR 2017/745:
Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be establishedIn addition to ensuring compliance to MDR 2017/745 and EU requirements, country-specific requirements for registration must be observed for the medical device. The quality team is responsible for registering the device's Unique Device Identifier (UDI) information (Basic UDI-DI and UDI-DI) in the European Database for Medical Devices (Eudamed) according to Art. 29 and Annex VI of MDR 2017/745, once Eudamed is fully functional. Until Eudamed registration is mandatory, appropriate national registration requirements should be followed, if applicable.
The Basic UDI-DI, UDI-DI and UDI-PI shall be created for the device according to the requirements of the MDR. Until the transition period for Eudamed is completed and it is available for UDI, UDI registration should be completed through UDI providers recommended by the European Commission. These include:
The quality team shall be responsible for creating the UDI for the device and registering the UDI in the appropriate database. The UDI should be created according to the requirements of the MDR and the appropriate UDI provider.
A new UDI-DI shall be required whenever a change occurs that could lead to the misidentification of the device or ambiguity in its traceability. The assignment of UDI-DIs is governed by the UDI issuing entity chosen by the manufacturer.
According to Annex VI, Part C, Section 3.9 of the applicable regulation (MDR 2017/745), a new UDI-DI is required for changes including, but not limited to:
presence of CMR/endocrine-disrupting substances)For software, significant changes as defined in relevant guidance (e.g., MDCG 2018-6) typically warrant a new UDI-DI. The Quality Team is responsible for evaluating changes against these regulatory requirements (MDR) and relevant guidance documents to determine if a new UDI-DI is necessary.
The quality team assigns a new UDI-PI for modifications such as:
The UDI-PI can be determined by the manufacturer. Typically, the device version number serves as the UDI-PI.
For the US market, medical devices must comply with FDA regulations (21 CFR). This includes obtaining Premarket Approval (PMA) or 510(k) clearance, or qualifying for an exemption, depending on the device classification. The quality team will be responsible for ensuring that all necessary documentation and testing are completed to meet FDA requirements.
For the US market, the declaration of conformity can be drafted after obtaining the necessary FDA approvals or clearances. The declaration of conformity should be signed by management to confirm that the device meets the requirements for the FDA and can be placed on the market in the US.
The declaration of conformity should include the following information:
To register a medical device on the Global Unique Device Identification Database (GUDID) before commercialization in the US post FDA approvals, follow these steps:
By following these steps, the medical device will be registered in the GUDID database, ensuring compliance with FDA regulations for commercialization in the US.
Upon successful completion of the declaration of conformity, product registration and UDI creation, the device is ready for release to the market.
The Software Release Checklist should be completed in order to provide a final review of the software and ensure that all necessary steps have been completed for the release of the device. The software release checklist should be completed by the quality team and the software team to ensure that all necessary steps have been completed, and all documentation reviewed for updates and completion for the release of the device.
For hardware medical devices, a Hardware Release Checklist should be completed to ensure that all necessary steps have been taken for the release of the device. This checklist should be completed by the quality team and the hardware team to confirm that all necessary steps have been completed, and all documentation reviewed for updates and completion for the release of the device.
If both the software and hardware checklists are complete and it is confirmed that all prerequisite documentation and steps are completed, the device can then be released to the market.
Below are the responsibilities with respect to this SOP by team:
MDR 2017/745 Annex I, Annex IV, Art. 27, 29, 31 – All