NECESSARY MEDICAL ASSESSMENT FOR RECENTIZATION
The CE marking is limited in time.
After the initial certification, the notified body carries out annual re-audits. In addition, medical devices must be recertified no later than 5 years after the award of the CE mark by the approval bodies (Notified Bodies) and, if necessary, will receive. a new certificate of conformity.
According to the previous MDD / AIMDD guidelines, re-certifications by the Notified Bodies are only possible until the end of the transitional period on 26 May 2020. From 26 May 2020 at the latest, manufacturers must be able to produce an EC certificate under the new MDR for the recertification of medical devices. Furthermore, manufacturers have the option to renew their existing certificates immediately before 26 May 2020. These then apply until the middle of 2024 at the latest.
The Clinical Assessment Body Prof. Zenner and Partners can perform the clinical evaluation and documentation at the recertification.
According to the new EU MDR, proof of the clinical effectiveness of a medical device and patient protection during recertification is provided without exception by means of a specialist clinical evaluation. A waiver of a clinical evaluationis usually intended only for absolutely non-critical products such as screws, wedges, plates and instruments.
The evaluation is completed by the assessment of the reasonableness of the benefit / risk ratio. In this final balance of risk, burden and benefit, the benefits must clearly outweigh.
The benefit-risk analysis and assessment is based on the collection and review of data and literature. Basically, the clinical evaluation is based on clinical data from recognized literature databases, FDA and BfArM notifications, personal data from PMS or data from competitors.