VIGILANZA E SORVEGLIANZA POST- COMMERCIALIZZAZIONE

Transcription

1 VIGILANZA E SORVEGLIANZA POST- COMMERCIALIZZAZIONE

2 VIGILANZA E SORVEGLIANZA POST-COMMERCIALIZZAZIONE Post-Market Surveillance dal punto di vista dell O.N in vista dei nuovi Regolamenti (MDR/IVDR) Francesco Laterza Regulatory Lead Global Oversight BSI Group TEAM-NB The European Association Medical devices Notified Bodies

3 EU Regulations Vigilance Economic Operators Healthcare Institutions Clinical Oversight Requirements Unannounced Audits Joint Assessments Directives + Interim Regulations & Recommendations New Regulations Time

4 PMS Article 83 Vigilance Article Reactive PMS Post Market Surveillance QMS PSUR Article 86 SSCP Article 32 Proactive PMS PMCF Annex XIV Applies to every class of device under every route of conformity.

5 MDR / IVDR European Database on Medical Devices Article 33 / Article 30 EUDAMED Electronic System on Registration of Devices Article 29 / Article 26 Electronic System on Notified Bodies & Certificates Article 57 / Article 52 (subsidiaries, experts, Notified Bodies, Certificates) + Summary of Safety & Performance Electronic System on Vigilance & PMS Article 92 / Article 87 (serious incidents, FSCA, trend reports FSN) + Periodic Safety Update Report Electronic System on Market Surveillance Article 100 / Article 95 (surveillance activities, devices presenting an unacceptable risk, non-compliant products, preventive health protection measures) Electronic System on Clinical Investigations Article 73 / Article 69 (sponsors, description of investigational device, status, adverse events) UDI Database Article 28 / Article 25 Electronic System on Registration Economic Operators (SRN) Article 30 / Article 27 5

6 Article 32 - Summary of Safety and Clinical Performance (SSCP) In the case of devices classified as class III and implantable devices, the manufacturer shall draw up a summary of safety and clinical performance. It shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be available to the public via EUDAMED. The draft of this summary shall be submitted to the notified body and shall be validated by that body. After validation the notified body shall upload this summary report to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary report is available. Article 49 Clinical Evaluation For devices classified as class III and implantable devices, the PMCF report and, if indicated, the summary of safety and clinical performance shall be updated at least annually with these data. Manufacturer + SRN Device + UDI Intended Purpose, Indications, Contra-indications Description, previous variant(s), differences, accessories, other products intended to be used in combination Possible diagnostic or therapeutic alternatives Harmonised Standards / Common Specifications Summary of the Clinical Evaluation Report + PMCF Suggested profile and training for users Information on residual risks, undesirable effects, warnings & precautions

7 Article 86 Periodic Safety Update Report Manufacturers of class IIa, class IIb and class III devices shall prepare a PSUR for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the PMS data gathered... Throughout the lifetime of the device concerned that PSUR shall set out: Article 86 PSUR: Conclusions of the benefit risk determination Main findings of PMCF Volume of Sales Estimate of the Population that use the device Where practicable usage frequency of the device Manufacturers of class IIb and III devices shall update the report at least annually. Manufacturers of class IIa devices shall update the report at least every two years. For custom-made devices the PSUR shall be part of the documentation referred to Annex XIII. Manufacturers of devices in class III or implantable devices shall submit reports by means of the electronic system to the notified body. The notified body shall review and add its evaluation to that electronic system with details of any action taken. Such PSURs and the notified body evaluation shall be made available to competent authorities through that electronic system. For devices other than class III or implantable, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.

8 Regulation EU 2017/745 NB involvement Quality Management System Incident and FSCA reporting (Article 97 & 92) Technical Documentation Unannounced Audit Clinical Evaluation Consultation Procedure (CECP) (Article 54) 2001/83/EC EC/726/ /23/EC EU 722/2012 PSUR (Article 86) (*Annual) SSCP (Article 32) Class III Implants *to NB for Class III *to NB for * * Class IIb Active Intended to administer and/or remove Medicines from the body *to NB for Sample per group * not submitted to NB Class IIb Implants *to NB for * Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins clips, connectors *to NB for Sample per group Class IIb *to NB for Sample per group * not submitted to NB Class IIa *to NB for Sample per category not submitted to NB

9 Regulation EU 2017/745 NB involvement Quality Management System Incident and FSCA reporting (Article 97 & 92) Technical Documentation Unannounced Audit Clinical Evaluation Consultation Procedure (CECP) (Article 54) 2001/83/EC EC/726/ /23/EC EU 722/2012 PSUR (Article 86) (*Annual) SSCP (Article 32) Class Is, Im, Ir *to NB for Class I *no NB involvement Class III Custom Made Implants *to NB for Custom Made Procedure Packs (Article 22) *to NB for Suppliers, Subcontractors *depends on certification held *depends on certification held EU Authorised Representatives, Importers, Distributors (Article 16) *impact sterile barrier, translate, repackaging Health Institutions *in-house manufacturing, singleuse reprocessing

10 MDR/IVDR transition Understand gaps in QMS Plan proper resources to cover new Vigilance and Clinical requriements Review agreements among economic operators Understand gaps in Technical documentation Classification / upclassification Clinical evidences Product changes / line extensions to be planned PMCF SIGNIFICANT WORK ONGOING TO ENSURE TRANSITION