Below we referenced useful items to support your compliance process. These have been compiled by or on behalf of mdi Europa and are thus not available free of charge. Please review and contact us, should you be interested in getting full access.
Supportive Information MDR
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Conformity Assessment Routes
Classification Rules
Knowing the appropriate classification rule and how to interpret them is an important foundation for conducting the correct conformity assessment procedure. We have useful checklists and guidance available and built a highly competent consulting network. If you would like to learn more, please get in touch with our team.
Declaration of Conformity
Requirements for setting up a Declaration of Conformity are much more specific. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
General Safety and Performance Requirements
The applicable General Safety and Performance Requirements must be fulfilled by each medical device manufacturer. The corresponding evidence should be provided and integrated in the technical documentation in an appropriate manner. We have useful checklists and guidance available and built a highly competent consulting network. If you would like to learn more, please get in touch with our team .
Technical File and Documentation
The technical documentation of a medical device represents documented evidence that the manufacturer complies with the regulatory requirements of Regulation (EU) 2017/745 on medical devices. It is vitally important that technical files are set up in accordance with the regulatory requirements. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Labeling Requirements
Labels and instructions for use are sensitive parts of the technical documentation and should be closely and strictly aligned with the device claims and further aspects. Regulation (EU) 2017/745 on medical devices is very prescriptive with regards to required labeling elements. It is essential that the related documents are set up in accordance with the regulatory requirements. Are you interested in receiving further details or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Clinical Evaluation
The clinical evaluation is among the most important processes under the regime of Regulation (EU) 2017/745 on medical devices. It is essential that the process and related documents are set up in accordance with the regulatory requirements. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Post-Market Surveillance
Post-market surveillance is a central process under the regime of Regulation (EU) 2017/745 on medical devices. It is essential that the process and related documents are set up in accordance with the regulatory requirements. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Supportive Information IVDR
Conformity Assessment Routes
Classification Rules
Knowing the appropriate classification rule and how to interpret them is an important foundation for conducting the correct conformity assessment procedure. We have useful checklists and guidance available and built a highly competent consulting network. If you would like to learn more, please get in touch with our team.
Declaration of Conformity
Requirements for setting up a Declaration of Conformity are much more specific. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
General Safety and Performance Requirements
The applicable General Safety and Performance Requirements must be fulfilled by each in vitro diagnostic medical device manufacturer. The corresponding evidence should be provided and integrated in the technical documentation in an appropriate manner. We have useful checklists and guidance available and built a highly competent consulting network. If you would like to learn more, please get in touch with our team .
Technical File and Documentation
The technical documentation of an in vitro diagnostic medical device represents documented evidence that the manufacturer complies with the regulatory requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. It is vitally important that technical files are set up in accordance with the regulatory requirements. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Labeling Requirements
Labels and instructions for use are sensitive parts of the technical documentation and should be closely and strictly aligned with the device claims and further aspects. Regulation (EU) 2017/746 on in vitro diagnostic medical devices is very prescriptive with regards to required labeling elements. It is essential that the related documents are set up in accordance with the regulatory requirements. Are you interested in receiving further details or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Performance Evaluation
The performance evaluation is among the most important processes under the regime of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. It is essential that the process and related documents are set up in accordance with the regulatory requirements. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
Post-Market Surveillance
Post-market surveillance is a central process under the regime of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. It is essential that the process and related documents are set up in accordance with the regulatory requirements. Are you interested in receiving a template or guidance? Do you need a qualified consultant? Then please get in touch with our team.
