This is the starting situation for many SMEs: a product that sells, satisfied customers, a directive certificate that expires in eighteen months, and a stack of MDR documents to read that seems insurmountable. The usual reflex is to start where you feel comfortable — rereading existing procedures, updating documents. This is generally the wrong priority.
Here is how to sequence the first weeks so as not to waste time on what is not urgent and not to miss what is.
Weeks 1-2: verify the MDR classification
Before anything else. The MDR classification may differ from the directive classification. If your device moves up a class — from I to IIa, from IIa to IIb — the entire certification programme changes. Starting on a class I programme and discovering six months later that the device is IIa under the MDR means starting over with several months of delay.
The MDR classification relies on the 22 rules of Annex VIII of Regulation (EU) 2017/745. For common devices, the exercise is straightforward. For ambiguous cases — software, combined devices, mixed-use devices — the MDCG 2021-24 guidance and the opinion of the ANSM can secure the decision.
Week 3: an honest documentation review
Not a formal audit. A quick review that answers three questions. Is there a technical file that describes the device as it exists today? Does a clinical evaluation exist, even a partial one? Does the QMS cover the processes required by Article 10(2) of the MDR?
The objective is to identify the critical gaps — those that will block certification — as opposed to formal gaps that can be filled later. A technical file that is deficient on the clinical evaluation is a critical gap. Labelling that does not yet have the ISO 15223 symbols is a formal gap.
Week 4: choose and contact a notified body
Counter-intuitive? No. Notified bodies’ lead times are long — 12 to 18 months for a first class IIa file is not uncommon. Contacting several notified bodies in the first few weeks to obtain realistic lead times and understand their specific expectations makes it possible to calibrate the rest of the programme.
Some notified bodies offer paid pre-submission meetings. For a first MDR file, this investment is often worthwhile: it allows the regulatory strategy to be validated before committing resources to assembling the file.
What not to do first
Completely redoing the QMS procedures. The procedures can be adapted progressively. Rewriting them from scratch is a consumption of time that does not bring certification any closer.
Ordering biocompatibility studies or performance tests without first having identified the critical gaps in the file. Studies ordered too early, or without precise scoping, often produce results that do not exactly answer the notified bodies’ questions.
Drafting the technical file before having the data. A file drafted with missing data is a file that you rewrite twice.