Using the Medical Device Directive guidance documents provided in Moodle to identify whether these changes require notification and provide your rationale and the type of supportive documentation you would expect to see with the change request: – please note in the absence of a comprehensive change control guidance document(s) for the MDR/IVDR assume all the below devices are regulated under the directives and you do not have to take into account the transition to the MDR.
Change # 1
A Muscle stimulator device is being changed to update the associated labelling for clarity and marketing purposes for rebranding – there is no change to the indications for use and you remain the manufacturer. The name of the product has also been changed as a result of the rebranding process.
The indications for use for the muscle stimulator are as follows
The muscle stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
Device Class: IIa; Rule 9
Conformity Assessment Route: Annex II.3 of Directive 93/42/EEC
Change # 2
A coronary guidewire will undergo a change in coating from a hydrophilic coating to a hydrophobic coating – this will require a full validation of the coating system including associated biocompatibility testing, age testing, sterilisation validation etc. The change is being introduced as a result of non-reportable customer complaints regarding the current coating. There have not been any associated health and safety issues with the current coating.
The indications for use for the guidewire are as follows:
“Product # 1 Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. Product # 1 Guidewires are not intended for use in the cerebral vasculature. The devices are provided nonpyrogenic, sterile, and intended for one procedure only.”
Device Class: Class III, Rule 6
Conformity Assessment Route: Annex II.4 of Directive 93/42/EEC
Change # 3
An implantable cardiac defibrillator product is changing the whole manufacturing process from Site A in Northern Ireland to an established site B in Southern Ireland – Site B had a Notified Body inspection last year with no associated deficiencies, both sites and product utilise the same notified body. There is no change to the manufacturer name or the manufacturing process or equipment etc. as a result of the change in site.
The indications for use for the implantable cardiac defibrillator are as follows
The implantable cardiac defibrillator is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Device Class: AIMD Device
Conformity Assessment Route: Annex II of Directive 90/385/EEC
Change # 4
A total knee replacement system is being updated so that the current indications are expanded to incorporate a new, quite novel indication for use (also a Class III indication) which will require a substantial program of pre-clinical and clinical data.
The indications for use for the total knee replacement system are as follows:
This device is indicated for patients with severe knee pain and disability due to:
• Primary and secondary traumatic arthritis,
• Avascular necrosis of the femoral condyle,
• Moderate valgus, varus, or flexion deformities (i.e., valgus/valgus deformity of <::15°, fixed flexion deformity of:Sl0°).
• This device is intended for cemented use only.
Device Class: III; Rule 8
Conformity Assessment Route: Annex III plus Annex V of Directive 93/42/EEC
Your answer for each change listed should include:
(a) Is the Change Reportable or not?
(b) Provide a written rationale referencing the appropriate section of one of the guidance documents to support your argument.
(c) Name 2 documents you would expect to be included within the change request to support the initiators argument.
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