Class I then Class IIa: is it possible to start with self-certification before upgrading your medical device? Classification differences, regulatory impacts and CE marking strategy to adopt.
A question we often encounter is whether it is possible to start with self-certification for a Class I MD and then upgrade the MD to Class IIa. Let's take a closer look:
Class I includes, for example, MDs such as DTx (Digital Therapeutics for patient use), while Class IIa encompasses more complex MDs, such as diagnostic support software MDs, or telemonitoring software MDs integrating alerts for healthcare professionals.
The rationale behind MD classification is mainly based on its intended use and the potential risks to patients.
Class I MDs are generally self-managed by manufacturers via self-certification, which significantly speeds up their market launch. In some cases, it can be very interesting for manufacturers to start with a Class I software MD to reach their market while simultaneously pursuing their clinical, regulatory and product strategy to develop and certify a Class IIa MD.
Class IIa MDs undergo stricter regulatory checks due to their complexity and increased risk potential, including audits by Notified Bodies (NB).
Manufacturers considering upgrading their MDs from Class I to Class IIa must prepare for a substantial update of their CE marking: Technical Documentation and Quality Management System (QMS). Any significant change in the design or intended use of the device that could influence its class must be rigorously documented. Clinical elements must be strengthened.
From a financial perspective, designing a Class IIa MD is more costly, as a Notified Body must be approached to carry out the MD assessment and issue the CE marking.
Book a meeting with the Sparta Care team to assess the risk class of your MD and the best marking strategy to adopt!
