Live Webinar – Nuovo regolamento Dispositivi Medici 745/2017 [ITA]: Principali Cambiamenti e Timeline per l’implementazione
Durata: 50 min. + 10 min. Questions Time.
Il corso è rivolto a personale di Assicurazione Qualità, Regolatorio e Ricerca e Sviluppo di aziende biomedicali fabbricanti legali di dispositivi medici di qualsiasi classe, mandatari e distributori.
- La nuova posizione della Commissione sui dispositivi medici;
- La tempistica di attuazione del regolamento,
- Gli impatti principali sui dispositivi esistenti,
- Gli impatti principali sui nuovi dispositivi.
Livello: intermedio, richiede conoscenza della attuale Direttiva DM.
Perchè Partecipare al Corso:
The new Regulations on medical devices
On 5 April, 2 new Regulations on medical devices were adopted. These replace the existing Directives.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
The new Regulations in a nutshell
The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:
- stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
- the reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
- the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;
- the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
- improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
- the introduction of an “implant card” containing information about implanted medical devices for a patient;
the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations the strengthening of post-market surveillance requirements for manufacturers;
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
More information is available in this presentation that contains general information on key changes contained in the Regulations and transitional periods.
The main reasons behind this change
Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector.
The new regulations will ensure:
- a consistently high level of health and safety protection for EU citizens using these products
- the free and fair trade of the products throughout the EU
- that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.
A chi è rivolto il Corso:
- Quality Manager
- Quality Engineers
- Design Quality
- Regulatory Affairs specialist
- Medical Affairs specialist
- Clinical Affair specialist
- R&D Engineers
Requisiti per il rilascio dell’attestato:
Il partecipante dovrà assistere all’intero corso e dovrà superare con esito positivo un test finale. Il certificato verrà rilasciato con un punteggio conseguito superiore all’80%. Il certificato firmato dal trainer verrà spedito via email e se richiesto anche via posta.
Il programma Online include:
- Risposte alle domande effettuate durante il live Webinar.
- Un quiz finale.
- Il rilascio di un certificato firmato dal trainer.
Corso Presentato da:
Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.
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