MDCG 2022-11 Update, November 2023: The position paper contains notifications to manufacturers and notified bodies regarding compliance with MDR and IVDR requirements.
It contains a call to manufacturers to adapt to the regulations (MDR and IVDR) and to submit their certification applications without further delay. MDCG recognices the efforts of manufacturers who have already adapted their systems to the regulations. However, the available figures show that the number of applications submitted for both regulations, but especially for the IVDR, is still low.
The document also contains an appeal to notified bodies. It is important that notified bodies streamline their procedures and make every effort to improve their conformity assessment activities in terms of transparency, timelines, predictability and consistency. Notified bodies are reminded that they must operate under coherent, fair and appropriate conditions, taking into account in particular the interests of SMEs with regard to fees. Adequate support to manufacturers with legal guidance and technical information on the application process is crucial to ensure a smooth and fast process and to avoid incomplete applications, which have been identified as a major cause of delays. Such support is particularly relevant for SMEs. MDCG reminds notified bodies to organice structured dialogues with manufacturers, which are part of the day-to-day pre-application and conformity assessment and should therefore not be an additional chargeable service.
MDCG 2023-4, Oktober 2023: Medical Device Software (MDSW) - Hardware Combinations, Guide to MDSW designed for use in combination with hardware or hardware components.
This document describes common constellations of manufacturers and suppliers that repeatedly lead to conflicts in the clarification of responsibilities. The following cases are listed and explained as examples:
- The manufacturer of the hardware component and MDSW application is a company
- The manufacturer of the hardware component and the MDSW application are different companies
- The manufacturer of the hardware component and MDSW app integrated in a wearable is a company
- Manufacturer of the wearable and MDSW app are different companies
Aus unserer Sicht lohnt sich ein Blick in dieses Dokument. Auch hier ist zu beachten das der Begriff „Manufacturers“ immer wieder missinterpretiert wird.
MDCG Veröffentlichung, September 2023: Guideline for the delimitation and classification of medical devices according to regulation and InVitro diagnostics. The following classification discussions are held in this guideline:
- Differentiation between medical devices and InVitro diagnostics
- Differentiation between medical devices and medicinal products, including advanced therapy medicinal products (ATMPs)
- Differentiation between medical devices and biocides
- Differentiation between medical devices and substances of human origin
- Differentiation between medical devices and cosmetic products
- Differentiation between medical devices and food products
- Differentiation between medical devices and personal protective equipment
These questions also arise time and again in our everyday lives. Deciding which direction to take is often difficult and has a significant impact on the conformity assessment procedure. We will be happy to help you with this issue and share our expertise with you.
Further information can be found online.
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