Re-classification

• Re-classification of all devices is already done. First check of our classification against the not yet published guidance, we are able to release the classification and estimate the next steps and their impact.

Conformity assessment

 • Related SOPs are under revision but also for those procedures a lot of questions are still open.

Technical documentation

• Gap analysis is done, missing data and documents are identified.
• Next step is to contact a notified body for a technical review.

Labelling

• Label templates were prepared to fulfill the new requirements as soon as they are needed.
• Instruction for use and manuals for instruments are under preparation.

Reporting

• Not yet started because a lot of questions are still open: how the reports should be submitted and also the templates concerning the content are unclear.

R&D of new products

• Related SOPs are under revision, new requirements are already considered during development.

Legacy products

• Gap analysis is finalized, missing data and documents are identified.
• Measurement of missing data is in process.

In the meantime the European Commission has published some fact sheets that should provide helpful information for all economic operators. For more information please visit: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en