G/TBT/N/EU/866  
18 January 2022  
(22-0370) 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/tb t/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Products 
without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 on 
medical devices.  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation laying down common specification s for the groups 
of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 
2017/745 of the European Parliament and of the Council on medical devices (7 page(s), 
in English; 35 page(s), in English)  
6. Description of content:  The common specifications (CS) for each of the groups of 
products listed in Annex XVI of Regulation (EU) 2017/745 on medical devices address the 
application of risk management, in respect of certain general safety and performance 
requirements set out in Anne x I of that Regulation. Examples for those Annex XVI 
products are cosmetic contact lenses; implants without medical purpose; facial, dermal 
or mucous membrane fillers; liposuction equipment; intense pulsed light or laser 
equipment for hair removal and brai n stimulators.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Products without an intended medical purpose listed in Annex XVI of 
Regulation (EU) 2017/745 will be regulated for the first time under the medical device  
legislation from the date of application of the common specifications. Therefore, the 
adoption of the common specifications is awaited by manufacturers of products without 
an intended medical purpose as well as notified bodies intended to be designated to  carry 
out the relevant conformity assessment procedures. The sooner the common 
specifications are adopted, the sooner the medical device regulation will cover also the 
products without an intended medical purpose, significantly enhancing the harmonisation  G/TBT/N/EU/866  
 
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  of the internal market and the safety of the products covered. 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:  2nd quarter 2022  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (The provisions shall apply as from six month after the date of their entering into 
force)  
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_0408_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_0408_01_e.pdf