In July 2023, the European Commission published the results of its latest survey among notified bodies regarding MDR/IVDR certificates and applications. Perhaps the most insightful result for manufacturers is the diagram showing the reasons for MDR application rejections. The top 3 most common reasons for rejection are as follows:

1. The device indicated in the application does not fall within the notified body’s scope of designation.

• This issue occurred in almost half (48%) of rejected applications.
• The scope of activities that can be performed based on the notified bodies’ designation is defined according to the codes specified in the Commission Implementing Regulation (EU) 2017/2185. The descriptions associated with the codes are quite brief, which increases the risk of errors. The MDCG 2019-14 guidance provides further information on which specific devices correspond to the relevant codes.

2. The application is incomplete.

• This issue occurred in nearly a fifth (18%) of rejected applications.
• A startling statistic reveals that in 55% of incomplete applications, the manufacturers submitted less than a quarter of the required documentation. To put this into perspective, for every 4 documents required by the MDR, the manufacturers failed to submit 3!

3. Incorrect classification of the product as a medical device or incorrect assignment to a risk class.

• This issue occurred in 16% of rejected applications.

The survey also highlights that the time required to obtain a new certificate remains 13-18 months on average (in 45% of cases), and in 23% of cases, the process takes even longer, 19-24 months.

Written by: Attila Juhász (Professional Lead, SAASCO Ltd.)