Dr. Guido Middeler
Diapharm GmbH & Co. KG
Medical devices and the OEM/PLM dilemma: Diapharm offers conformity assessment body services
Beginning on 26 May 2020, manufacturers who have used the traditional OEM/PLM approach based on ZLG document 3.9 B16 will face a fundamental problem: Due to the abolition of Article 11, paragraph 7 MDD, it will no longer be possible to simply refer to the original manufacturer’s certificates within the scope of one’s own conformity assessment. As a result, legal manufacturers must themselves assess or receive an assessment of the conformity of the product. They will also need to be able to demonstrate this assessment to their notified body and, if applicable, to the responsible competent authority in such a way that these bodies or authorities are convinced of its correctness. It therefore has to be possible to submit the complete technical documentation of the medical devices in question – including the previously “closed part” containing all trade secrets of the original manufacturer – to the notified body and, if applicable, to the competent authority. This constitutes a threatening situation for both parties due to the reluctance to hand over trade secrets, especially to companies with an economic incentive to make further use of such secrets. Both parties risk losing business should the original manufacturer not be prepared to give the third party full access to the technical documentation. Diapharm now offers a validated solution to this tricky legal problem with its new Trustee Assessment Service conformity assessment body.