Notification Detail | TRIS - European Commission

Decree on the reconditioning of certain medical devices.

Notification Number:

2023/0135/F (France)

Date received:

24/03/2023

End of Standstill:

26/06/2023 (closed)

Draft Text:

FR HU PL MT PT EL IT SK DA LT ES SV GA LV NL ET BG FI SL HR EN RO DE CS

Impact assessment:

FR EN DE

Final Text:

FR BG CS DA DE EL EN ES ET FI GA HR HU IT LT LV MT NL PL PT RO SK SL SV

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Message

Message 002

Communication from the Commission - TRIS/(2023) 00788
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2023/0135/F

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 202300788.EN)
1. MSG 002 IND 2023 0135 F EN 24-03-2023 F NOTIF

2. F

3A. Ministères économiques et financiers
Direction générale des entreprises
SCIDE/SQUALPI - Pôle Normalisation et réglementation des produits
Bât. Sieyès -Teledoc 143
61, Bd Vincent Auriol
75703 PARIS Cedex 13

3B. Ministère de la santé et de la prévention
Direction de la sécurité sociale
Sous-direction du financement du système de soins
Bureau des produits de santé - 1C
14, avenue Duquesne
75350 PARIS 07 SP

4. 2023/0135/F - S00S

5. Decree on the reconditioning of certain medical devices.

6. Medical devices for individual use (reimbursable by health insurance on the basis of their inclusion in the list of reimbursable products and services - the LPP - provided for in Article L. 165-1 of the Social Security Code).

7. -

8. This decree lays down the rules guaranteeing the quality and safety of use of reconditioned medical devices after they are put into service and the rules on coverage by health insurance (the national social security scheme) and the traceability of such products.

As a reminder, Regulation (EU) 2017/745 of 5 April 2017 on medical devices does not harmonise the provisions governing the making available on the market of medical devices after they have already been put into service, in particular in the context of second-hand sales (recital 3).

The main provisions defined in the decree are:
- a full definition of the reconditioning of a medical device after it has already been put into service;
- a regulatory framework for the activity of reconditioning (development of an AFNOR technical standard, certification procedures for reconditioning centres, procedures for monitoring certifying bodies and sanctions for approved centres in the event of non-compliance);
- rules for the distribution of reconditioned devices;
- the patient's commitment with regard to the reconditioned device as part of the coverage by the health insurance scheme;
- Identification of the reconditioned product with the unique device identifier provided for in Article 27 of Regulation (EU) 2017/745 of 5 April 2017 on medical devices, affixed by an authorised operator;
- content, management and access to the national wheelchair traceability platform “ECO-DM”;
- the transitional period for the entry into force of the decree.

For example, wheelchairs for persons with disabilities fall within the aforementioned category of medical devices for individual use and should normally be the first products to which the provisions of this decree will be applied.

Currently, the entry into force of this decree is scheduled for 1st July 2023, subject to the outcome of this procedure.

9. The purpose of the measure is twofold:

- to avoid waste and rapid obsolescence by extending the period of use of the medical devices concerned, while guaranteeing their safety of use with the creation of an AFNOR technical standard for reconditioning and with the traceability of these devices in an information system called the Registration of the Official Circulation of Medical Devices (ECO-DM);
- to allow the patients concerned more access to these reconditioned devices – under all the required health safety conditions – and to be reimbursed by health insurance with limited personal expenses.

10. References to basic texts: - Having regard to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC;
- 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,as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020;
- Article L. 5212-1-1 of the Public Health Code (derived from Article 39 of the Social Security Financing Act for 2020);
- Article L. 165-1-8 of the Social Security Code (derived from the same Article 39 of the LFSS for 2020).

11. No

12. -

13. No

14. No

15. Yes

16. TBT aspect

NO - The draft does not have a significant impact on international trade.

SPS aspect

NO - The draft does not have a significant impact on international trade.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	Year	Number	Country	Type	Title	Date received	Is answer to
111287	2025	0774	COMEuropean Commission	049	Acknowledgement of receipt of the adopted text	19-03-2025

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