Regulatory affairs for combination products

Whether a product is a ​“medical device with an inte­gral medi­c­inal product compo­nent” or a ​“medi­c­inal product with an inte­gral medical device compo­nent” deter­mines the type of autho­ri­sa­tion – and the sequence in which the neces­sary regu­la­tory steps must be taken. We support you in clar­i­fying demar­ca­tion issues and in effi­cient project plan­ning to meet the complex requirements.

• Support on demar­ca­tion issues, clas­si­fi­ca­tions, compli­ance with require­ments of the respec­tive corre­sponding regulations
• Consul­ta­tion, prepa­ra­tion, eval­u­a­tion of docu­men­ta­tion and expert reports
• Biolog­ical evaluations
• Clin­ical evaluations
• Exper­i­mental and analyt­ical work for proof of conformity
• Organ­i­sa­tion of and support during consul­ta­tions with authorities
• Organ­i­sa­tion of and support during pre-assess­ments with appointed bodies
• Execu­tion of the consul­ta­tion or certi­fi­ca­tion process
• Prepa­ra­tion of posi­tion papers to clas­sify border­line products