The Regulatory Affairs and Consulting Department of Abich-Lifeanalytics can assist and support you in the various stages of certification of your medical device according to Regulation (EU) 2017/745. On March 20, 2023, Regulation (EU) 2023/607 was published in the Official Journal of the European Union, which under certain conditions extends the validity period of certificates issued under the Directives until December 31, 2028, but despite the extension, it is important not to be caught unprepared and to meet the new obligations envisaged by the MDR correctly, starting in good time to submit the formal request to the Notified Body and, above all, to respond to their initial requests.
Abich can support you for substance-based medical devices also with the drafting of:
✅ Gap Analysis, to define all the steps to be taken to comply with MDR regulations;
✅ Qualification rationales, to define the qualification of the product as a medical device and the classification according to the new rules;
✅ Rationales supporting the mechanism of action of the medical device;
✅ Biological evaluation (BEP/BER) according to ISO 10993-1;
✅ Rationales for defining markers to be analyzed in percutaneous absorption tests;
✅ Bibliographic evaluation of the ADME of medical device ingredients.
As an integral part of the evaluation of a medical device, biocompatibility tests are an undeniable priority to assess its safety. Abich is a GLP certified laboratory that provides in vitro and in vivo biocompatibility tests aimed at the three endpoints that all medical devices are required to evaluate:
✅ Cytotoxicity: ISO 10993-5;
✅ Irritation: ISO 10993-23;
✅ Skin sensitization: ISO 10993-10.
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