With the release of Regulation MDR (EU) 2017/745, the amount of MDR applications has not kept up with the amount of certificates of MDD that will need to be updated to the current regulation. According to the Medical Device Coordination Group, “Compared to the over 24,000 certificates issued under Directives 90/385/EEC and 93/42/EEC, only around 13,000 MDR applications have been lodged and 3,900 certificates have been issued”1 since June 2023 with “those 3,900 issued MDR certificates, around 1,000 are related to updates.“1 What does this mean when we look at upcoming deadlines and audit capacity when it comes to Notified Bodies?
As we know, auditing takes scheduling and time to be able to complete with each Notified Body (NB) having a limited number of auditors for each regulation or standard, whether those are full-time auditors or contractors. If there are 24,000 MDD certificates, and only 13,000 MDR applications submitted, there are 11,000 potential MDD to MDR update applications waiting to be submitted. When it comes to capacity, will your company be able to have an MDR certificate in hand before the deadline of December 2027 or 2028?
If you are waiting on scheduling audits, keep in mind that the MDR conformity assessment process “takes longer than under the former directives”1 with “time for assessment under MDD on average was up to 12 months, under MDR up to 18 or even 24 months.”1 When it comes to your company and the devices you manufacture or manufacture parts for, can you afford to wait? And even if you do submit an application before the May 2024 deadline, will you be able to schedule an audit before your required deadline?
When looking at scheduling, these will be determined by the NB on a first come first served basis. So, if you need a class D audit, or product certificates that fall under the December 2027 transition deadline, will holding off on your application until the 2024 deadline ensure your audit is completed in your required timeframe? At DQS, we understand that your time is valuable and that you may have questions about the transition process which is why we have experts that are available to speak with you about MDR and what it entails.
DQS can answer questions such as “which MDR transition deadline do I fall under?”, “how to I apply or find the application for MDR conformity assessment?”, or “How can I change my Notified Body with minimum disruption of my business?” We currently are scheduling 2024 MDR conformity assessments and would be able to speak with you about your goals for this transition. Speak with us today by contacting sales.us@dqs.de or use the form below. We can also assist with speaking with you about MDSAP, ISO 13485, and ISO 27001:2022 which can aid with cybersecurity and protecting your data and digital assets. We look forward to working with you and your business to become MDR certified.
1 Medical Device Coordination Group (MDCG). 2023. MDCG 2022-11 Rev.1 MDCG Position Paper. Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. Medical Device Coordination Group Document.
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Author
Robyn Daiss
She is a graduate of the University of Texas at Austin with a B.A. in American Studies. She uses her diverse experience in development, administration, and more to provide engaging content and information for those pursuing continuous growth in their businesses with certifications and training.
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