To which risk class can or must a specific medical device be assigned? This question cannot always be answered straight away. The regulatory requirements often leave room for interpretation and leave manufacturers at a loss. The free classification consultation day with Prof. Dr. medical Michael D'Agosto. He holds the professorship for medical technology with a focus on product approval at Furtwangen University, Tuttlingen campus. In 40-minute individual discussions, the participants can ask their classification questions and determine a non-binding assessment in dialogue.
In order to be able to get a comprehensive picture, relevant documents and information on the products in question (e.g. intended use, instructions for use) should be at hand.
Information helpful for the interview (if applicable and available):
- Designation of the product or the product category or the product group
- If applicable code, e.g. EMDN/CND code, MDR codes according to MDCG 2019-14 (MDA/MDN/MDS/MDT) or others.
- Intended purpose/intended use in accordance with the instructions for use
- If applicable, indication / contraindication / patient population
- Further promised services from other product-related information (e.g. marketing documents, videos, etc.)
- Software (drives product or is independent of product) ?
- Possibly combination with other products
- Duration of use (up to 60 minutes, up to 30 days, longer than 30 days)
- Place of application / degree of invasiveness (invasive, natural orifice, surgically invasive, implantable),
- Contact with / application to the central circulatory system?
- Reusable surgical instrument?
- measurement function?
- Sterile?
- Active medical device?
- Therapeutic / diagnostic?
- Control / regulation / control of other products?
- Ionizing radiation?
- Using biological material from animals or humans?
- Delivery or involvement of substances or combinations of substances that are absorbed by the human body or distributed locally in the body?
The one-to-one sessions take place between 4:00 p.m. and 7:00 p.m. Desired times can be entered under “Remarks” when registering; otherwise the slots will be allocated in the chronological order of the registrations.
KONTAKT:
Online
