Whether a manufacturer of medical devices is preparing technical documentation for a new product for MDR certification or transitioning a product from MDD to MDR, one of the most important stages is the preparation of the technical documentation for MDR submission.
Not so long ago, the European Commission released the results of its 10th survey of Notified Bodies (NBs), for which responses were provided by all 49 NBs designated under MDR at the time of the survey. This survey reveals how NBs have processed certifications and applications for transitioning products to the MDR, reflecting many interesting findings. The survey shows progress in the number of applications being filed with NBs and certificates being issued under the MDR. However, there continue to be issues with applications that result in refusals from NBs. In particular, the survey states that 16% of MDR applications were refused due to incomplete documentation. For 43% of NBs, it takes 13-18 months from the signing of the written agreement to the issuance of a new CE certificate under MDR. For 39% of NBs, this period is 19 months or more, while only 18% of NBs complete the process in less than 12 months. One of the key reasons for these prolonged durations is the quality of the documentation submitted by manufacturers. Nearly half of the NB’s reported that fewer than 25% of submissions were deemed complete, meaning that in over 75% of cases, NBs had to request additional information from manufacturers. This results in delays at the start of the conformity assessment process and typically leads to further delays during the assessment itself.
85% of NBs indicated that 50% or more of the time during the procedure is spent on the manufacturer’s side. This suggests that the delays are related to initially incomplete documentation, or the time required to prepare additional information.
Thus, despite the abundance of guidance documents that provide clarification and recommendations for preparing technical documentation for MDR submissions, the current experience of NBs suggests that manufacturers are still facing challenges in preparing high-quality, compliant technical documentation for MDR submission.
Starodub’s team of experts helps manufacturers navigate the complexities of MDR requirements and overcome the challenges of preparing high-quality technical documentation.
Whether you are in the early stages of preparing technical documentation, progressing through the process, or almost ready for submission, we offer tailored support to meet your specific needs. We analyze your documentation against the latest requirements and recommendations, ensuring compliance with guideline documents and Notified Bodies’ expectations, which helps minimize the risk of incomplete submissions and reduce delays in the certification process. Contact us for more information.
