Dear Karl,

I would ask for you kind guidance regarding the below questions I have received from our supplier regarding Custom Made Device regulations in Estonia?

Custom Made Device (CMD) refers to a device that is:

• Requested by a surgeon for the treatment of one named patient,

• Is not available in the requesting country, and

• Is designed and manufactured on a case-by-case basis.

Examples include (but are not limited to):

• A device designed to match the anatomy of a unique individual (patient matched)

• A device that is customized for a unique individual (for instance, smaller or larger sizes than what is commercially available)

• A device that was available on the market at one time but is no longer available (may be available in other markets – such as commercially available in the U.S., but no longer bears CE- mark)

• A device that is obsolete

• A device that has been customized to fit a patient’s unique needs (for instance, a customized taper adapter to bridge between 2 well-fixed products)

1. Does the Health Authority have CMD or other special device access routes?

Yes / No

Comments:

2. Which types of special device access routes are allowed? Check all that apply:

3. Is registration (or similar) with the Health Authority required for CMD?¨

Yes / No

Comments:

4. Is approval from in-country Health Authority required for CMD?

Yes / No

Comments:

5. What regulatory documents or certificates are required for registration or importation of the CMD? Check all that apply.

                 ☐ EU MDR GSPR Checklist (See Example: Attachment 1 - FRM022032)

☐  Statement Concerning Specialty Devices (See Example: Attachment 2 - FRM022010)

                 ☐ Declaration of Exemption (See Example: Attachment 3 - ANZ DOE)

                 ☐ Technical Documentation Checklist (See Example: Attachment 4 - FRM022009)

       ☐ Other: Please specify:

6. Please indicate any additional country-specific requirements that need to be considered.                                                                                                               (Example: Special Shipping Instructions, Additional Labeling, etc…)

                 ☐ Importer Verification Process at GSCC (MDR inspection)

                       Comments: Click here to enter text.

                   ☐ Notification to in-country RA at shipment

                       Comments: Click here to enter text.

                   ☐ Other - Please specify:

Britta Nylund

Operations & Quality Manager

+358 10 292 4632

Sipoonranta 10 B LT 1, FIN-01120 Västerskog

Finland

ISO 13485:2016 Certified