As far as the scope of the clinical evaluation report is concerned, as in the third edition, the scope of the clinical evaluation should be based on the basic requirements (ER) that need to be met. Appendix 7 of the fourth edition of MEDDEV 2.7.1 provides many additional guidelines on how to analyze clinical data to demonstrate that it meets the basic requirements. For example, the fourth edition of MEDDEV 2.7.1 proposes to demonstrate that the relevant clinical data meets Article 6 of the Medical Device Directive MDD 93/42/EEC (Active Implantable Medical Device Directive AIMDD 90/385/EEC Article 5 of the basic requirements) The relevant requirements for adverse side effects, the scope of clinical research must be large enough to be able to have a reasonable possibility of observing such adverse side effects from the sample. As the frequency of such side effects decreases, the number of subjects needs to increase substantially. Therefore, in human key clinical studies for medical devices, the sample size is larger than in the past, and the notified body has begun to implement this requirement.
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One of the biggest changes in the fourth edition of MEDDEV 2.7.1 is that the difficulty of proving "substantial equivalence" is much greater than before. The most critical requirement is that a device must meet all three general criteria (clinical, technical, and biological) to prove "substantially equivalent." In addition, the fourth edition of MEDDEV 2.7.1 also requires manufacturers to include supporting non-clinical information (such as preclinical reports) on the device in the technical documentation of the device, that is, the manufacturer must be fully accessible (ie, "own ") Technical documentation / design file for the comparison device. It is important to recognize that the relevant clinical data used during the clinical evaluation process must be derived from medical devices that meet the requirements of the Medical Device Directive MDD/Active Implantable Medical Device Directive AIMDD. Therefore, if a non-CE certified device (eg, a device that receives US 510K or PMA) is selected as a substantially equivalent device (contrast device), then the manufacturer must have a patient population or clinical practice between the country where the device is approved for marketing and the EU. A reasonable explanation for any discrepancies.
Appendix 2 of the fourth edition of MEDDEV 2.7.1 provides guidance on when clinical trials are needed. Of course, according to Section 1.1a of Appendix X of the Medical Device Directive 93/42/EEC, implantable devices and Class III devices must undergo clinical trials (unless there are other valid reasons). In addition, the fourth edition of MEDDEV 2.7.1 also stipulates that the following situations also require clinical trials: the use of new or existing clinical new uses of the device; any gaps in existing clinical data are insufficient to justify the device ( The benefits, risks, requirements or side effects of the use of Class I, Class IIa and Class IIb devices meet the applicable basic requirements. Clearly, the above regulations have made it possible for few manufacturers to demonstrate that the device meets the applicable basic requirements only through clinical literature and clinical experience data.
In addition, the fourth edition of MEDDEV 2.7.1 also specifies the roles and responsibilities of the Notified Body. Some of the major changes are that the Notified Body must establish the required QMS procedures for the evaluation of clinical evaluation reports and must have the expertise required to evaluate clinical evaluation reports. In addition, the notified body also needs to issue a clinical evaluation report (CEAR) for all clinical evaluation cases evaluated. The Clinical Evaluation Assessment Report (CEAR) can be used as part of a design dossier or technical documentation report (if any).
In summary, the fourth edition of MEDDEV 2.7.1 will lead to more clinical trials and possibly larger sample sizes, and accordingly, the Notified Body will need to review all applicable basic requirements (including those related to availability). Whether it has been met. Clinical evaluation reports themselves also require more frequent updates, written and reviewed by more experienced evaluators, and more closely integrated with the various phases of the device lifecycle. With the introduction of the fourth edition of MEDDEV 2.7.1 and no transition period between the old and new versions, it is in the best interest of the manufacturer to discuss with the notified body how to start implementing these new requirements and implement the gap assessment from now on. Resource needs assessment. Gap assessment is imminent as manufacturers need to budget for additional clinical data as soon as possible. Therefore, if the clinical trial needs to be initiated in 2017, the cost of the assessment will need to be recorded in the budget plan for next year.
Original English
Revised Guidance Document for Clinical Evaluation in the EU [MEDDEV 2.7.1 (rev 4)]
With regard to the scoping of CERs, as in rev 3, the scope for the clinical evaluation should be based on the essential requirements (ER) that need to be addressed. Annex 7 now gives lots of additional guidance on how to analyse the clinical data To show that it meets the ERs. For example, it now makes the point that to meet ER6 of the MDD (ER 5 AIMD) - unwanted side effects - studies must be large to have a spontaneous probability of seeing such side-effects in The sample. As the frequency of the side effect in the population decreases, this leads to dramatic increases in the number of subjects required. Thus larger first in men and pivotal studies for medical devices are expected than usual seen in the past, as notified bodies Already start to exercise this requirement.
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