On July 25th, 2023, the Medical Device Coordination Group (MDCG) released the results from a Notified Body survey on certifications and applications under the MDR and IVDR, updated results until March 31st, 2023.
A Notified Bodies survey on certifications and applications under MDR and IVDR.
This latest survey was conducted at the beginning of April 2023 and it includes the requested data from notified bodies designated under MDR/IVDR until March 31st 2023. The survey outcomes, published on July 25th, 2023, shed light on the current state of certifications and applications in the medical industry.
Here are some key take home messages to share:
There was a 100% response rate from the in total 39 Notified bodies at the time.
For medical devices:
- It clearly indicates that on average it takes now 2-3 months from an application lodged to a written agreement
- MDR applications are being predominantly refused for following reasons
- 208 for being outside the scope of the notified body’s designation
- 80 for not submitting a complete application
- 74 for a wrong qualification or classification of the product
- Unfortunately also 35 applications also ended due to “withdrawal of the application by the manufacturer – not ready for MDR, due to economic reasons, etc.
- More then 55% of submitted applications were deemed incomplete and even worse, incomplete submissions are on the rise
- Time needed for certification: 13-18 months for 45% of applications filing for QMS+ product conformity VS 29% of applications filing for QMS conformity
For in vitro diagnostic medical devices:
- A gap between applications & issued certificates deepens further: 950 IVDR applications vs 331 certificates (vs 822 applications vs. 268 certificates in October 2022)
- Predominant reasons for refusal:
- 39 applications were withdrawn by the manufacturer (not yet ready for IVDR, due to economic reasons, ..) (!)
- 7: application incomplete
- Please note that this data was only completed by 1 notified body
- Most certificates are now issued under Annex IX (I&III) (395) and Annex IX (II) (534) of which in total 182 class D certificates have been issued.
- Very few certificates have been issued under Annex X coupled with Annex XI (A): 21 in total of which 1 class D certificate
- the IVDR completeness check still proves that majority of applications submitted to the notified body are incomplete (60%)
- Time needed for certification: 13-18 months for 60% of applications filing for QMS+ product conformity VS 40% of applications filing for QMS conformity
What does this mean to you?
Did you already started making your portfolio MDR or IVDR compliant?
First, before signing a contract, always carefully check if your devices are indeed covered by the scope of the notified body and make sure your application is complete.
If you did not start preparations to make your portfolio in compliance with the new MDR and IVDR, the time to act is now! After the announcement of the transitioning regulation for both MDR and IVDR, notified bodies see a significant drop in applications. Don’t wait till it’s too late!
For a complete updated list of notified bodies designated under MDR and IVDR, please see this recently published overview.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
