Following the entry into force of the Communiqué on the Determination of Common Specifications for Product Groups Without an Intended Medical Purpose Listed in Annex XVI of the Medical Device Regulation (“Communiqué) published in the Official Gazette dated 14 March 2024, the Guideline on Determination of Common Specifications for Product Groups Without an Intended Medical Purpose Listed in Annex XVI of the Medical Device Regulation has been repealed with the approval of the Turkish Medicines and Medical Devices Agency.
With the Communiqué, the scope of the harmonisation clause with the European Union (“EU“) legislation has been extended, and the timelines have been extended to align with the revised transitional provisions for product groups without an intended medical purpose, such as contact lenses, liposuction and laser equipments, as outlined in EU legislation. The regulations introduced by the Communiqué are not only significant in terms of the compliance of sector players with the legislation, but also hold significant importance in harmonising with the EU legislation.
Share
Related persons
You can contact us for detailed information.
Legal Information
This briefing is for information purposes; it is not legal advice. If you have questions, please call us. All rights reserved.
You May Be Interested In
10 September 2024
Turkish Data Protection Authority and Turkish Ministry of Trade sign cooperation protocol on targeted advertising and dark patterns
The Turkish Personal Data Protection Authority and the Turkish Ministry of Trade General Directorate of Consumer Protection and Market…
16 August 2024
Turkish Competition Law Newsletter – 2024 Summer Issue
We are pleased to share our quarterly newsletter on recent developments under Turkish Competition Law.
16 August 2024
New Regulatory Framework Unfolded for Establishment of Crypto Platforms
Following the July 2, 2024, introduction of the crypto asset regulation law under the Capital Markets Law No. 6362, the Capital Markets…
7 August 2024
Key Changes in the Local Tax Legislation
Paksoy legal briefing: “Key Changes in the Local Tax Legislation”
24 July 2024
Amendments on the Communiqué on Principles Regarding Real Estate Investment Funds
The Communiqué Amending the Communiqué on Principles Regarding Real Estate Investment Funds (III- 52.3) (“Amendment Communiqué”) has been…
18 July 2024
Turkish Data Protection Authority issues new regulation on cross-border data transfers
Paksoy legal briefing: “Turkish Data Protection Authority issues new regulation on cross-border data transfers”