EU MDR Class I Device Compliance Guide
In 2024, the European Commission acknowledged that only 45 Notified Bodies had been designated under the MDR — down from roughly 80 under the previous Medical Device Directive. The resulting bottleneck has delayed recertification across all device classes, and several EU Member States have reported that up to 20% of Class I manufacturers had not fully transitioned their technical documentation from MDD to MDR format during spot checks. A non-sterile Class I device may not need a Notified Body, but that self-declaration must still be built on the new regulation's structure — and outdated documentation is treated the same as no documentation during a competent authority audit.
Under the EU Medical Device Regulation (MDR — Regulation [EU] 2017/745), all medical devices placed on the European market require a Declaration of Conformity. Class I devices are the lowest-risk category but the documentation burden is far from trivial. On the Sustalium platform, the area where we see Class I manufacturers submit incomplete documentation most frequently is the new clinical evaluation and post-market surveillance requirements — obligations that simply did not exist under MDD.