Vigilance Guidance update
Even though the new regulation is in place, and a specific area is available where you will find guidance and most likely the new Implementing Acts (HERE), it needs to be noted that the Guidance site is still being updated for the MDD (MDDEV). The latest update can be found in section 2.12 “Post-Market surveillance”. The most important update is the “New Manufacturer Incident Report”. This form shall as well apply for the MDR. Therefore, it makes sense to implement. We assume that member states most likely will accept the new form, but they will have to update their system. Having stated that, the Dutch authority provided a communication that they would expect the new form.
The legal status is now the following:
It is a guidance. It is not a must, but it will be expected to be utilized!
Under the MDD/IVD rules only member states can make this form mandatory in their countries (remember the MDD was transposed into each country law). We expect this for Germany once BfArM publishes it on their website. Others will follow accordingly. Then the form must be used in those countries.
Under the MDR it can mandated via an implementing act Europe wide. We expect this once the industry has some experience with it. This may also depend on the implementation of Eudamed. In case it is mandated under the MDR/IVDR then it must be applied once the Declaration of Conformity under the MDR is being signed. Even though you may still have a MDD/IVD certificate for the “soft transition” you then must apply this form for all products, at the latest on the MDR/IVDR application date. MDR/IVDR Vigilance shall be applied for all products upon the application date.
Please note the other updates as well. For example, we would strongly recommend to consider the Field Safety Notice Template. It should avoid comments from the Competent Authority (CA). Please check HERE for the updates.