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Semelhante a Medical devices: 7 steps to CE-mark, and post-market surveillance
Semelhante a Medical devices: 7 steps to CE-mark, and post-market surveillance (20)
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Medical devices: 7 steps to CE-mark, and post-market surveillance
- 1. Conformityassessmentprocedure 7stepstotheCEmark A crash course for (future) medical device manufacturers
- 2. Step1:Qualifyingthedevice Document the intended purpose of the device § Medical purpose of the medical device § Intended patients, diagnoses, body parts § Physical principle of the medical deviceIntended users and use environments § ... Use the intended purpose to fix whether the device is a medical device.
- 3. Step2:Identifyingthelegalbasis Determine which of the following EU regulations apply to your medical device: § Medical Device Regulation MDR § In-vitro diagnostics regulation IVDR Read the definitions in the MDR.
- 4. Step3:Determiningregulatoryrequirements § Determine the class of the device – The MDR distinguishes between classes I, IIa, IIb and III – The IVDR distinguishes between classes A to D – Annex VIII of the MDR and IVDR determine the classification rules. § Determine conformity assessment procedures (see next page)Determine basic safety and performance requirements If you are unsure, ask your notified bodies or us:https://www.johner-institute.com/contact-us/
- 5. Annex II Technical Documentation Annex X Conformity Assessment by Type Examination Annex IX Conformity Ass. based on QM System and Assessment of Technical Documentation Annex XI (Part A): Conf. Ass. by Product Conformity Verification: Production QS Annex IV and V DoC to MDR CE marking without NB Annex IV and V DoC to MDR CE marking with NB I IIb, III I*, IIa, IIb, III I*, IIa IIa Specific Assessment Procedure including expert panels Annex XI (Part B): Conf. Ass. by Product Conformity Verification: Product Verification (done by NB) III*, IIb* IIb, III IIb, III I*, IIa DoC: Declaration of Conformität (Konformitätserklärung) NB: Notified Body (benannte Stelle z.B. TÜV) Class
- 6. Note § You always need a quality management system. § In the case of a conformity assessment procedure in accordance with Annex IX (previous page, far right), that quality management system must be certified.
- 7. Step4:EstablishingtheQMsystem § Establish an ISO 13485-compliant QM system. This will take you a few months. § This investment will save you months of time and produce better devices. § If you don't know how to establish a QM system, ask us: https://www.johner-institute.com/contact-us/
- 8. Step5:Developinganddocumentingthedevice § Develop the device in accordance with your own QM system. § In this way, legally compliant technical documentation is created. This contains, for example – Intended purpose (see step 1) and instructions for use – Risk management files – Usability file – Clinical evaluation
- 9. Step6:Declaringconformity/approvingthedevice § Create a declaration of conformity § Involve a notified body, except for Class I § Affix the CE mark to your device § Sell your device, help patients and earn money!J
- 10. Step7:Monitoringthedeviceonthemarket § Create a plan (post-market surveillance plan) § Collect and evaluate information according to the plan § If necessary, define and implement measures (e.g., improve device, improve processes, recall product, inform authorities) § Document activities (e.g., post-market surveillance report)
- 11. Wouldyoulikesupport? Benefit from the fast and competent help of the Johner Institute so that you can bring your devices to market quickly and with safety. Get in touch with us: § https://www.johner-institute.com/contact-us/ § info@johner-institut.de § +49 (7531) 94500 20