With system for clinical evaluation according to MDR<\/h2><\/h2><\/div>It is indispensable for manufacturers of medical devices of all risk classes:
\nThe clinical evaluation according to MDR. In accordance with Regulation (EU) 2017 \/ 745 (MDR) and as part of the conformity assessment procedure, documentation is a prerequisite for successful market access and must be planned.<\/p>\n
As part of the technical documentation, it is the basis for a safe medical device. The legal requirements are all the greater. But what exactly is the clinical evaluation for?<\/p>\n
Above all, it is systematic proof that the medical device fulfills basic safety and performance requirements. The side effects that patients must expect and the consequences that can be excluded are also documented in the clinical evaluation. It thus serves as proof of a justifiable risk-benefit ratio.<\/p>\n<\/div>
<\/i><\/div>Good to know<\/h3><\/div><\/div>\nA common misconception:<\/strong> Class I products do not need a clinical evaluation. This is wrong, because every medical device is bound by the requirements of the MDR. Even if the notified body does not carry out a clinical evaluation for Class I devices, an evaluation must still be available on request.<\/p>\n<\/div><\/div><\/div><\/div><\/div>![\"BAYOOMED](\"https:\/\/www.bayoomed.com\/wp-content\/uploads\/sites\/4\/2024\/06\/BAYOOMED-Mit-System-zur-klinischen-Bewertung-nach-MDR.jpg\" "\\"BAYOOMED")
<\/span><\/div>Systematic for clinical evaluation<\/h2><\/h2><\/div>How do you create a clinical evaluation? Above all, the preparatory work is crucial: first, the process and the requirements for the product must be planned and a strategy for obtaining clinical data developed. You can obtain this data from studies from scientific literature research. Clinical trials are also suitable.<\/p>\n
This process is part of the technical documentation. This means that all steps of the clinical evaluation must be planned and recorded in a report.<\/p>\n<\/div>
CEP and CER – what are they?<\/h3><\/h3><\/div>The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents of the technical documentation. They provide information on how manufacturers proceeded when preparing the clinical evaluation.<\/p>\n<\/div>
- <\/i><\/span>\n\n
\nClinical Evaluation Scope & Plan (CEP):<\/b><\/p>\n<\/header>\n\n\n- includes basic safety and performance requirements that must be supported by relevant clinical data<\/li>\n
- requires specifications of the intended purpose of the product as well as a target group with indications and contraindications<\/li>\n
- serves as a detailed description of the intended clinical benefit for patients<\/li>\n
- formulates relevant parameters for the clinical outcome and a clinical development plan<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div><\/li>
- <\/i><\/span>\n\n
\n\nClinical Evaluation Report (CER):<\/b><\/p>\n<\/header>\n\n\n- serves as a report on the procedure planned in the CEP<\/li>\n
- contains all relevant information on the safety, performance and clinical benefit of the medical device<\/li>\n
- based on Article 61 of the MDR<\/li>\n<\/ul>\n<\/div>\n<\/header>\n<\/div>\n<\/div><\/li><\/ul>
Important:<\/h3><\/h3><\/div>The documents must be constantly updated over the product lifetime using PMCF data.<\/p>\n
The ongoing and regular updating of the clinical evaluation after the medical device has been placed on the market is also part of the Post Market Clinical Follow-up (PMCF).<\/p>\n<\/div><\/div><\/div><\/div><\/div>
<\/i><\/div><\/div>
It is indispensable for manufacturers of medical devices of all risk classes:
\nThe clinical evaluation according to MDR. In accordance with Regulation (EU) 2017 \/ 745 (MDR) and as part of the conformity assessment procedure, documentation is a prerequisite for successful market access and must be planned.<\/p>\n
As part of the technical documentation, it is the basis for a safe medical device. The legal requirements are all the greater. But what exactly is the clinical evaluation for?<\/p>\n
Above all, it is systematic proof that the medical device fulfills basic safety and performance requirements. The side effects that patients must expect and the consequences that can be excluded are also documented in the clinical evaluation. It thus serves as proof of a justifiable risk-benefit ratio.<\/p>\n<\/div>
Good to know<\/h3><\/div><\/div>\nA common misconception:<\/strong> Class I products do not need a clinical evaluation. This is wrong, because every medical device is bound by the requirements of the MDR. Even if the notified body does not carry out a clinical evaluation for Class I devices, an evaluation must still be available on request.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/span><\/div>Systematic for clinical evaluation<\/h2><\/h2><\/div>How do you create a clinical evaluation? Above all, the preparatory work is crucial: first, the process and the requirements for the product must be planned and a strategy for obtaining clinical data developed. You can obtain this data from studies from scientific literature research. Clinical trials are also suitable.<\/p>\n
This process is part of the technical documentation. This means that all steps of the clinical evaluation must be planned and recorded in a report.<\/p>\n<\/div>
CEP and CER – what are they?<\/h3><\/h3><\/div>The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents of the technical documentation. They provide information on how manufacturers proceeded when preparing the clinical evaluation.<\/p>\n<\/div>
- <\/i><\/span>\n\n
\nClinical Evaluation Scope & Plan (CEP):<\/b><\/p>\n<\/header>\n\n\n- includes basic safety and performance requirements that must be supported by relevant clinical data<\/li>\n
- requires specifications of the intended purpose of the product as well as a target group with indications and contraindications<\/li>\n
- serves as a detailed description of the intended clinical benefit for patients<\/li>\n
- formulates relevant parameters for the clinical outcome and a clinical development plan<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div><\/li>
- <\/i><\/span>\n\n
\n\nClinical Evaluation Report (CER):<\/b><\/p>\n<\/header>\n\n\n- serves as a report on the procedure planned in the CEP<\/li>\n
- contains all relevant information on the safety, performance and clinical benefit of the medical device<\/li>\n
- based on Article 61 of the MDR<\/li>\n<\/ul>\n<\/div>\n<\/header>\n<\/div>\n<\/div><\/li><\/ul>
Important:<\/h3><\/h3><\/div>The documents must be constantly updated over the product lifetime using PMCF data.<\/p>\n
The ongoing and regular updating of the clinical evaluation after the medical device has been placed on the market is also part of the Post Market Clinical Follow-up (PMCF).<\/p>\n<\/div><\/div><\/div><\/div><\/div>
<\/i><\/div><\/div>
A common misconception:<\/strong> Class I products do not need a clinical evaluation. This is wrong, because every medical device is bound by the requirements of the MDR. Even if the notified body does not carry out a clinical evaluation for Class I devices, an evaluation must still be available on request.<\/p>\n<\/div><\/div><\/div> How do you create a clinical evaluation? Above all, the preparatory work is crucial: first, the process and the requirements for the product must be planned and a strategy for obtaining clinical data developed. You can obtain this data from studies from scientific literature research. Clinical trials are also suitable.<\/p>\n This process is part of the technical documentation. This means that all steps of the clinical evaluation must be planned and recorded in a report.<\/p>\n<\/div> The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents of the technical documentation. They provide information on how manufacturers proceeded when preparing the clinical evaluation.<\/p>\n<\/div> Clinical Evaluation Scope & Plan (CEP):<\/b><\/p>\n<\/header>\n Clinical Evaluation Report (CER):<\/b><\/p>\n<\/header>\n The documents must be constantly updated over the product lifetime using PMCF data.<\/p>\n The ongoing and regular updating of the clinical evaluation after the medical device has been placed on the market is also part of the Post Market Clinical Follow-up (PMCF).<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/span><\/div>Systematic for clinical evaluation<\/h2><\/h2><\/div>
CEP and CER – what are they?<\/h3><\/h3><\/div>
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Important:<\/h3><\/h3><\/div>