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During the 10x conference in San Diego last month, we discussed the changes to the EU regulations for CE Marking. If you are interested in downloading the slide decks for free, please visit the following link:
The most important update I learned was that the guidance document for clinical evaluations (MEDDEV 2.7/1) is being updated from revision 3 to 4. This was a popular subject at the 2015 RAPS meeting in Baltimore. It was stated that ISO 14155 will be a de facto requirement for device companies and the clinical evaluations will need to be updated on a continuous basis. Neither of these points differ from my own current procedures for conducting clinical evaluations, however, the subject of literature reviews concerned me.
Currently, most companies with medium and low-risk devices perform literature reviews instead of conducting a clinical study in order to meet the requirement for clinical evaluations. However, there has been an increased emphasis on the importance of determining whether similar devices with clinical data are actually equivalent. If clinical data for other products is not accepted in a clinical evaluation in lieu of a clinical study, then many device manufacturers may find themselves forced to conduct clinical studies. My first question was, “What about Class 1 devices where investigators have no desire to perform a clinical study?”
These changes to clinical evaluation requirements may just be the beginning of changes. The New European Regulations are expected to be finalized and approved by the other committees and implemented this fall. If history repeats itself, we should expect to see a flurry of new and revised MEDDEV guidance documents over the next year. In order to check for updated guidance documents, visit the following Europa webpage at least once a month:
Most companies are concerned about the new Scrutiny Process that could potentially delay approval of Class IIb implants and Class III products in the EU. However, for companies that don’t have implants I think the requirements for Economic Operators (i.e., Authorized Representatives, Distributors and Importers) will require additional guidance and significant advanced preparation for compliance. In addition, the FDA had significant difficulty providing access to companies establishing a GUDID for UDI barcoding. The European Eudamed database is likely to have even greater challenges, because there are 33 competent authorities, dozens of languages and the database will be new to everyone. The New European Regulations will specify requirements, but companies will need instructions, help and guidance for completing the new database when they are registering CE Marked products.
I am always looking for new topics and questions for my blog and this announcement, please let me know what you want to learn more about next week by posting a comment to our subgroup or by visiting my suggestion box: http://medicaldeviceacademy.com/suggestion-box/.
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