Kiri

Dear Stivani,

Thank you for your inquiry.

1. For this question, please see Medical Devices Act § 11 and § 11¹, where the term „professional user“ is defined, and the process of ordering custom-made device is explained.

§ 11.  Professional users of medical devices

For the purposes of this Act, a professional user of a medical device is a person who uses a medical device in the process of provision of health care or other services, and also in study, science or research.

§ 11¹.  Ordering custom-made medical devices

  Custom-made medical devices are manufactured according to the special order of a professional user based on the needs of a specific patient.

2. Until EUDAMED is fully functional, the obligations stated in Medical Device Act § 41² must be followed:

Until the implementation date of the obligations set out in points d and e of subsection 3 of Article 122 of Regulation (EU) 2017/745 and in points a and f of subsection 3 of Article 113 of Regulation (EU) 2017/746 of the European Parliament and of the Council related with the European database on medical devices, the exchange of information with the Health Board and the transmission of data to the Health Board takes place according to the wording of the Medical Devices Act in force prior to entry into force of this wording.

The previous act can be found here - https://www.riigiteataja.ee/en/eli/ee/503022022001/consolide and the relevant paragraph is 26.

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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Hello, 

I’m unsure whether I’ve reached the correct section however, I have some questions regarding custom made devices and EUDAMED compliance that I haven’t been able to find on your website. 

1. Custom made devices 

As per MDR, custom made devices are made only after prescription from health care professional is issued. Requirements of who is considered as health care professional are not mentioned in MDR rather mentioned in national legislations. So my questions is: 

• Who is considered as ‘health care professional’ and where is it stated in the national law? 

2. EUDAMED compliance

What is the method that is intended to be followed until EUDAMED is fully functional and becomes applicable mandatorily? 

I hope that you can help me. 

Kind regards,

Stivani

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