Dear Britta

Thank you for your enquiry.

There are two sources that you can turn to for answers to the questions you have recieved – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR) and Estonian Medical Devices Act (MDA).

MDR Annex XIII is the main legislative act that sets the requirements for procedures related to custom-made devices in Estonia. Please read the Medical Device Coordination Group’s Q&A Document on custom-made devices as well to gain further understanding of the requirements set by MDR.

Distribution notification obligation for custom-made medical devices is based on MDA §26 (3) which states that „Every undertaking who makes a custom-made medical device available on the market notifies the Health Board of the intention to make such medical device available on the market at least 10 days prior to making such medical device available on the market.“ Notification can be completed through the Estonian Medical Devices and Appliances Database (EMDDB). A short guide for using the EMDDB can be found on the database website in the „Forms“ section. In there you will also find the list of documents required for the notification process with the exemption of Declaration of Conformity which is replaced by the Annex XIII statement.

Please familiarize yourself with the above mentioned sources and don’t hesitate to contact us again should you have any further questions.

Best regards

Janne Aule

Chief Specialist

Department of Medical Devices

+37258668664

[email protected]

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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