Strategies for Successful CE Certification: Mitigating Non-Conformities and Streamlining Review Cycles

Strategies to facilitate approval of CE certificate and limit review cycles from the notified Bodied for Legacy devices and new products are discussed below.

Notified body reviewers commonly provide feedback related to claims, as the MDR does not use the specific term “clinical claim” and instead refers to “clinical benefit.” According to Article 2(53) of the MDR, clinical benefit is defined as the positive impact a device has on an individual’s health, expressed in terms of measurable, meaningful, patient-relevant clinical outcomes, including outcomes related to diagnosis or a positive impact on patient management or public health. It is essential to note that benefits must be meaningful, measurable, and have patient-relevant outcomes. One of the main difficulties manufacturers face is identifying these claims/clinical benefits and their associated endpoints or outcomes. Additionally, it is necessary to determine the criteria or points to be considered to determine the benefit-risk profile before the clinical evaluation. To ensure acceptance from the notified body, acceptance criteria must also be presented in detail.

CE Certificates for Medical Devices

The following content discusses feedback provided by the notified body related to the approval of CE certificates for medical devices. In some cases, clinical claims or benefits were identified correctly, but feedback was provided regarding the type of data used to support these claims. When non-clinical or pre-clinical data was used, or in the scenario of insufficient clinical data, non-conformities were raised. To avoid this issue, it is important to only use clinical data to support claims and benefits. Another issue that has caused confusion is the Clinical Development Plan (CDP) requirement. Whether the device is new or legacy, a CDP is required, and non-conformities related to its existence and content have been raised.

Literature Search Protocols

Finally, the validation of literature search protocols has been another common non-conformity cited by the notified body. To avoid this, validation of the search protocol used to identify published clinical literature is required, along with mechanisms to avoid bias and determination of data weightage from studies in terms of quality and relevance.

Strategies for CEPs

Simple strategies can be implemented while drafting Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) to mitigate these non-conformities. Claims should be categorized as either direct or indirect, and the type of data that will be used to support the claims should be clearly explained in the CEP. For indirect benefits, non-clinical or pre-clinical tests are acceptable evidence, while clinical evidence is often required for indirect benefits.

To facilitate the determination of the benefit-risk profile and acceptance criteria for a device, it is important to study the data available for similar and alternate technologies intended for the same purpose. This can be done by referring to relevant guidelines, consensus documents, and industry standards. Acceptance criteria are dynamic and change with each evaluation.

For both new and legacy devices, a CDP is necessary. For a new device, the CDP should include details of all initial studies, while for legacy devices, it should outline the device’s history on the market and the type of data used to obtain CE marking initially. The CDP could be a separate document or a subsection of the Clinical Evaluation Plan.

Systematic Literature Search Validation

To validate a systematic literature search, it is important to ensure that most or all relevant data has been retrieved without having to screen through excessive literature. The search must also be reproducible and done by multiple people to avoid bias. All datasets must be included and analyzed for weightage, which must be predetermined in the evaluation plan. The procedures followed and tools used for the literature search must be documented in the Clinical Evaluation Plan or a separate Literature Search Validation Protocol document.

By following these steps, the number of major review comments from the notified body on the Clinical evaluation can be minimized, leading to a quicker CE marking approval process for new or renewed devices.

Successful CE Certification: Key Take Away for Manufacturers

In conclusion, obtaining CE certificate approval for medical devices can be a complex process, especially with the new MDR Regulations in place. To avoid non-conformities and reduce review cycles from the notified body, it is crucial to identify clinical benefits with meaningful and measurable outcomes and to use only clinical data to support claims.

A CDP is necessary for both new and legacy devices, and a validated literature search protocol is vital to avoid bias and ensure accuracy. By following simple strategies such as categorizing claims, identifying acceptance criteria, and studying available data, manufacturers can minimize major review comments and obtain speedy approval for their devices. It is essential to document all processes and procedures in the Clinical Evaluation Plan or a separate Literature Search Validation Protocol document to ensure compliance and accuracy. By doing so, manufacturers can ensure that their medical devices are safe and effective for patients while meeting all regulatory requirements.