Article 117: Creating and Reviewing Technical Documentations to be Sent to Notified Body to Obtain a Notified Body Opinion

Article 117 is applicable for devices which are intended to administer a medicinal product and where the medicinal product is placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable. In this case the combined product is governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable.

At confinis, we understand the critical role that Article 117 of the MDR plays in the approval of combination products. Our expertise lies in creating and meticulously reviewing technical documentation required for obtaining a Notified Body Opinion. This documentation must be comprehensive, detailing all aspects of the product design, manufacturing processes, and quality controls to meet the stringent standards set by regulatory authorities.

Our process involves close collaboration with clients to ensure that every element of the technical documentation is accurate and complete. We conduct rigorous internal reviews and audits to identify and address any gaps or deficiencies. By staying updated on the latest regulatory guidelines and requirements, we help clients submit high-quality documentation, reducing the risk of delays and enhancing the likelihood of obtaining a favorable Notified Body Opinion.