Some manufacturers find themselves without valid MDR technical documentation: an expired directive certificate that was not renewed, a notified body that ceased operating without transfer, or a file that was never compiled under the directive. The situation is uncomfortable but not irretrievable. It can be resolved with method.
Step 1: establish a precise inventory before starting
Before writing a single procedure or contacting a notified body, you need to know exactly what you have. What was the device under the directive? Was there a technical file, even a partial one? Do any test reports still exist? Was any clinical data collected? Does the manufacturer hold a valid ISO 13485 certification?
This inventory takes two to four weeks and shapes everything that follows. A partially existing file — even in directive format — is always faster to rebuild than starting from scratch.
Step 2: classify the device under MDR
The MDR classification may differ from the directive classification. If the device moves up in class (from I to IIa, or from IIa to IIb), the whole approach changes: a notified body becomes mandatory, the clinical evaluation becomes more demanding, and costs and timelines increase. This classification decision drives the rest of the project.
Step 3: identify the critical gaps
The critical gaps are those that genuinely block obtaining the CE marking. Typically: insufficient or absent clinical evaluation, missing or obsolete biocompatibility data, lack of sterilisation process validation, non-existent risk management file.
These gaps define the programme of studies and tests to be launched. Some studies take several months (biocompatibility according to ISO 10993: three to six months). This duration cannot be compressed.
Step 4: sequence the work correctly
A technical file is rebuilt sequentially, not in parallel on all fronts at the same time. The logic: classification and regulatory strategy first, risk management in parallel with design, clinical evaluation as soon as performance data is available, drafting of the technical file once substantial data has been gathered.
Starting to draft the file before the data is available produces an incomplete file that constantly has to be reworked.
Step 5: anticipate the relationship with the notified body from the outset
Choose and contact the notified body at the start of the project, not at the end. Some notified bodies offer pre-submission meetings that allow the regulatory strategy to be validated before the formal submission of the file. These early exchanges avoid building a file in a direction that the notified body would not accept.
What cannot be accelerated
Clinical data must be substantial and credible. It is impossible to write up clinical data. If data is missing, the options are: a clinical investigation (lengthy, costly), a demonstration of equivalence if the conditions are met, or a systematic collection of retrospective data arising from past use of the device. This last option is possible and often under-exploited — but it requires a rigorous method to be accepted by notified bodies.