YOUR COMPLIANCE JOURNEY FOR MEDICAL DEVICES / IVDs (CE MARKING)
Get familiar with the steps & timeline!
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1. Your RA consultant will send you Annex A – List of devices.
2. Customer Relations dept. will share the Order Form to cover compliance process.
3. Accounting dept. will share with you the related invoice.
PRE-COMPLIANCE PROCESS
What will Obelis do?
1. To fully complete & sign & send back Annex A to Obelis.
2. Carefully review the Order Form & add signature & send it back to Obelis.
3. Settle the payment of the invoice.
What we need from you?
1. Send you instructions letter on the needed documentation.
- Provide you with checklists (gap assessment) & templates
2. Grant access to the online Repository
- Watch a short video how to navigate the Repository:
- Legacy device
- MDR/IVDR complaint device
3. Review your documentation as per applicable regulatory requirements.
4. Provide feedback on your documentation.
COLLECTION OF NECESSARY DOCUMENTATION
What will Obelis RA consultant do?
What we need from you?
1. To upload all the necessary documentation to the Repository.
- Watch a short video how to navigate the Repository
- Legacy device
- MDR/IVDR complaint device
2. Complete the checklists & templates.
3. Inform us once the upload of the documentation is complete.
4. Provide updated documentation implementing feedback given by your RA consultant.
1. Perform the necessary notification/registration.
NOTIFICATION / REGISTRATION
What will Obelis RA consultant do?
1. Obelis PRRC will review your documentation. If conclusion is positive:
2. Your RA consultant will share with you the AR Mandate together with Annex M for signature (via Adobe).
3. Obelis PRRC will sign the AR Mandate.
a. Obelis officially act as your Authorised Representative for devices listed in the Annex M.
MANDATE SIGNATURE
What will Obelis do?
What we need from you?
1. Review & sign the Mandate.
1. Send you Certificates’ specimens for review.
2. Upon confirmation, send you finalized Certificates per email.
OBELIS CERTIFICATE ISSUANCE
What will Obelis RA consultant do?
What you need to do?
1. Review specimens & confirm the information.
1. Remain available for any questions, queries.
2. Send you regulatory updates through MDlaw.
ACCESS TO THE MARKET
What will Obelis do?
What you need to do?
1. Translate your labels & IFUs – when applicable.
2. Inform us of any changes to your documentation, organization.
3. You can now use Obelis as your EC REP on the device’s labels.
STEP 1
STEP 2
STEP 3
STEP 4
STEP 5
STEP 6
What we need from you?
1. Send any additional documentation (translated labels & IFUs for ex.)
Not sure about your process?
Obelis Group
Boulevard Brand Whitlock 30, Brussels, 1200, Belgium
Tel: +3227325954
Fax: +3227326003
sales@obelis.net
© Obelis Group 2023
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