Dive Brief:

• Kiwa Cermet Italia has become the 21st notified body to be designated under the European Union's Medical Device Regulation.
• The designation, the first since MDR took effect in May, adds to the pool of notified bodies that is available to process the thousands of certificates that are set to expire before 2024.
• Based on the European Commission pipeline, Kiwa looks set to be joined by two more newly designated MDR notified bodies soon but many organizations are still early in the process. MedTech Europe in late May warned that several challenges are hindering the successful deployment of the new regulatory system including limited capacity among notified bodies, especially for certification of new and innovative devices.

Dive Insight:

Trade groups representing medical device manufacturers and notified bodies have continued to raise concerns about limited capacity for the certification of products under MDR. MedTech Europe has particular concerns about certification of new and innovative devices, while a Team-NB notified body survey found there were 17,383 certificates under the old directive that will expire by 2024.

Additional notified body capacity is coming online slowly. Kiwa is the first new MDR notified body since the date of application in late May and the fourth organization to be designated this year. The Kiwa designation ends a journey it began in September 2018.

Other notified bodies are still back at the start of the process. The Commission has applications from 50 notified bodies, including the 21 it has already designated. As of May 27, eight of the applicants were yet to get to the preliminary assessment report stage, the first step in the process after filing. 

The experience of Kiwa suggests it will take months and years for notified bodies near the start of the process to be designated under MDR, limiting their role in the effort to process the many thousands of directive certificates that are set to expire before the grace period ends in 2024. However, there is evidence that some additional notified bodies will be designated in time to make a contribution. 

Kiwa was one of three notified bodies that had received a recommendation from the Medical Device Coordination Group but was yet to be MDR designated at the time of the most recent update from the Commission. While that suggests news of the 22nd and 23rd notified bodies is near, all the other applicants are still multiple steps from being cleared to assess medical devices under MDR.

For Kiwa, designation under MDR is part of a broader expansion program. The Italian notified body is now aiming to obtain clearance to assess medtech products as part of FDA's Medical Device Single Audit Program and the UKCA mark now used for conformity assessments in the U.K.