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MEDSAFE WORKSHOP June 2007

Overview of a Device. The manufacturers intended purpose of a device determines its status as a medical deviceMedical devices deliver their intended effect through non-pharmacological means (e.g. mechanical, electrical, radiation). Medical devices range from low risk products such as bandages t

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MEDSAFE WORKSHOP June 2007

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    1. MEDSAFE WORKSHOP June 2007

    2. Overview of a Device The manufacturers intended purpose of a device determines its status as a medical device Medical devices deliver their intended effect through non-pharmacological means (e.g. mechanical, electrical, radiation). Medical devices range from low risk products such as bandages to higher-risk products such as implantable heart valves. Medical devices are classified or grouped in two main ways either by type or by risk.

    3. DEVICES Medical Devices notified on WAND divided into classification

    4. SPONSORS The number of sponsors that have listed a particular class of device

    5. TOTALS

    6. PROJECT RESPONSE

    7. OBSOLETE ENTRIES There were approximately 1540 Deletions

    8. INDUSTRY MAKE-UP

    9. WAND COMPREHENSION 75% of sponsors indicated that they have a minimal satisfactory understanding of WAND 52% of sponsors have indicated that they also use DEAL

    10. TROUBLESHOOTING

    11. WAND USABILITY 51% of respondents found the overall usability of WAND SATISFACTORY 30% of respondents found the usability GOOD 12% of respondents chose POOR 137 Sponsors could answer this question others had no experience of WAND

    12. PREFERRED SUPPORT OPTIONS Receive WAND Manuals and other printed material 26% Participate in WAND Workshops 22% Only new WAND related updates 19% Undertake computer based training 18% Individual (one-on-one) Consultations 11% No support required 4%

    13. INDUSTRY COMMUNICATION

    14. GMDNs Global Medical Device Nomenclature system A naming system chosen by the Global Harmonisation Task Force (GHTF) Device Categories (1- 20) a device may fit into more than one The Generic Device group has 4 different Term Types Preferred Term (P) used for naming Template Term (T) and <specify> (grouping) Synonym Term (S) common name (for navigation only) Multiple Linked Synonym Term (MS) higher level for linking to multiple P and/or T Terms Device Type Concern of the Manufacturer may be used for Unique Product Identification GMDN Code: A unique five digit number used to identify each term, these are unintelligent.

    15. GMDNs Definition of the device usually states the intended purpose. Only (P) and (T) terms have definitions.

    16. Risk Classification Risk classification is dependant on the type of device, level of invasiveness and length of use. Conformity assessment requirements increase with increasing risk classification

    17. Duration of use Transient = < 60 Minutes Short Term = > 60 Minutes < 30 Days Long Term = > 30 Days

    18. Invasiveness Non Invasive Invasive (in an orifice) Surgically Invasive Implantable

    19. Presence of an Energy Source Active Medical Devices Active Implantable Medical Devices

    20. Conformity Assessment Procedures The conformity assessment procedures in the draft Rule are specified in Schedule 3. These procedures include: Full quality assurance procedures Self assessment procedures Production quality assurance procedures Verification procedures Product quality control procedures Type examination procedures.

    22. COMMON DATA ISSUES The following list highlights the kind of problems that are commonly encountered with Application forms and Manufacturers Evidence attached to an application. The incorrect type of Evidence is attached; Must be of an approved type for ANZTPA. E.g. The FDAs 510(k) is not an acceptable form of evidence. Manufacturers Name, Address and other contact details are incorrect. Details have to be the same as are written on the certificate. The conformity assessment procedure that a certificate is issued under is not stated on the certificate or is not applicable to the class of device e.g. the Annex of the EC Medical Device Directive All device classes that require evidence are not included on the certificate (there may be specific exclusions also stated on the certificate)

    23. COMMON DATA ISSUES The assessment body used may not be an accepted notified body or its allocated number is not stated Evidence dates that are not current or incorrectly stated The evidence used is not an original or notarised copy; a photocopy is not acceptable. Incomplete Evidence is attached where the document has multiple pages GMDN codes are incorrect or not covered by the evidence.

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