REGULATORY SPOTLIGHT
Insights into Annex XVI – Article 3 of 3: “Prerequisites for a Clinical Investigation of Medical Devices without a Medical Purpose”
July 24, 2024
Are you planning a clinical investigation in the complex landscape of medical device regulations, particularly concerning products without a medical purpose (Annex XVI, REGULATION (EU) 2017/745 (MDR)?
REGULATORY SPOTLIGHT
Insights into Annex XVI – Article 2 of 3: “Clinical Investigations of Medical Devices without a Medical Purpose”
June 21, 2024
Are you navigating the complex landscape of Medical Device Regulations (MDR) concerning products without a medical purpose (Annex XVI, MDR)? Symbio Proinnovera can help!
REGULATORY SPOTLIGHT
Insights into Annex XVI – Article 1 of 3: “Designing the Investigator’s Brochure”
June 5, 2024
This article highlights the “guidance on content of the Investigator's Brochure for clinical investigations of medical devices - MDCG 2024-5,” recently published by the Medical Device Coordination Group (MDCG). The guideline is helpful in creating the Investigator's Brochure, a key document in the submission package to NCAs, and helps avoid queries in the submission process.
This guideline is also applicable for products listed in Annex XVI of REGULATION (EU) 2017/745-Medical Device Regulation (MDR). Annex XVI lists products without an intended medical purpose which are nevertheless covered by MDR.
