G/TBT/N/EU/916  
12 August 2022  
(22-6122) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Certain 
active products without an intended medical purpose listed in Annex XVI of Regulation 
(EU) 2017/745 on medical devices (the MDR).  
5. Title, number of pages and language(s) of the notified document:  Draft 
COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down rules for the 
application of Regulation (EU) 2017/745 of the European Parliament and of the Council 
as regards reclassificati on of groups of certain active products without an intended 
medical purpose; (4 page(s), in English)  
6. Description of content:  The measure reclassifies groups of active products without an 
intended medical purpose, by way of derogation from Annex VIII to  Regulation (EU) 
2017/745. The groups of products covered are laser devices, intense pulsed light devices, 
liposuction equipment and brain stimulation devices listed in the Annex XVI to Regulation 
(EU) 2017/745.  
7. Objective and rationale, including the n ature of urgent problems where 
applicable:  The classification Rules 9 and 10 of Section 6 of Annex VIII to Regulation 
(EU) 2017/745 refer only to active therapeutic devices or to active devices intended for 
diagnosis and monitoring and classify these devic es in risk classes IIa, IIb and III, 
respectively. Active products without an intended medical purpose, to which the MDR will 
apply, including Annex VIII on Classification Rules, after the adoption of the common 
specifications on Annex XVI products, would therefore inadvertently be classified in the 
lowest risk class I, according the residual criteria of Rule 13.  
According to Article 51(3) to MDR, some EU Member States jointly requested the 
reclassification of certain active products without an intended medical purpose by way of 
derogation from the provisions of Annex VIII to Regulation (EU) 2017/745, in order to G/TBT/N/EU/916  
 
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  ensure an appropriate conformity assessment of those active products, before their 
placing on the market, that is consistent with their inherent risks.  
EU Member States are very concerned about the safety of these products in the absence 
of the reclassifica tion measure and are strongly recommending the Commission to adopt 
this measure at the same time of the Commission Implementing Regulation laying down 
common specification on Annex XVI products, which will trigger the application of the 
Regulation (EU) 201 7/745 to Annex XVI products.; Protection of human health or safety  
8. Relevant documents:   
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 
on medical devices, amending Directive 2011/83/EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC . (OJ L 117, 5.2017, p. 1 -175).  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32017R0745  
9. Proposed date of adoption:  4th quarter 2022  
Proposed date of entry into force:  The day after its publication in the Official Journal 
of the EU  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_5514_00_e.pdf