EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) 2022/2346 as regards the transitional 
provisions for certain products without an intended medical purpose listed in Annex 
XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council  
(Text with EEA rel evance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) 2022/2346 as regards the transitional 
provisions for certain products without an intended medical purpose listed in Annex 
XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Function ing of the European Union , 
Having regard to 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/EEC1, and in particular Article 1(2), in conjunction with Article 9(1), thereof , 
Whereas:  
(1) Article 2(1) and (2) of Commission Implementing Regulation (EU) 2022/23462 set out 
transitional provisions for products for w hich clinical investigations are performed or 
for which a notified body has to be involved in the conformity assessment . Article 2(3) 
of that Implementing  Regulation also sets out  specific transitional provisions for 
products covered by a certificate issued by a notified body in accordance with Council 
Directive 93/42/EEC3. 
(2) Regulation (EU) 2023/ 607 of the European Parliament and of the Council4 extend ed 
the transitional period  provided for in Regulation (EU) 2017/745 for certai n medical 
devices, including those  which are covered by a certificate issued by a notified body in 
accordance with Directive 93/42/EEC  that is valid , until 31 December 2027 or 31 
December 2028, depending on the risk class of the device.   
(3) To ensure consiste ncy and provide legal certainty for economic operators, the 
transitional provisions set out in Implementing Regulation (EU) 2022/2346 for 
products covered by a certificate issued by a notified body in accordance with 
Directive 93/42/EEC  should be aligned with those set out in Regulation (EU) 
2017/745 , as amended by Regulation (EU) 2023/607 . 
(4) Products covered by a certificate issued by a notified body in accordance with 
Directive 93/42/EEC  benefit from a specific transitional provision laid down in 
Implementing Regulation (EU) 2022/2346 . The provision  has been applicable since 22 
                                                 
1 OJ L 117, 5.5.2017, p. 1.  
2 Commission Implementing Regulation (EU) 2022/2346 of 1  December 2022 laying down common 
specifications 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 Coun cil on medical devices (OJ L 
311, 2.12.2022, p. 60).  
3 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).  
4 Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending 
Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical 
devices and in vitro  diagnostic medical devices  (OJ L 80 , 20.3.2023, p. 24 ).  
EN 2  EN December 2022 and allows those products to be placed on the market or put into 
service subject to certain condit ions, even if the certificate has expired. To the extent 
that such products do not benefit from the extended transitional provisions provided 
for in Regulation (EU) 2017/745 , as amended by Regulation (EU) 2023/607, the 
possibility to continue to place  them on the market or put  them  into service even if the 
certificate issued by a notified body in accordance with Directive 93/42/EEC  has 
expired,  should be provided as a specific transitional provision in this Regulation.  To 
ensure consistency, applicable cond itions set out in Article 120 of Regulation (EU) 
2017/745 , as amended by Regulation (EU) 2023/607, should be met.  
(5) In order t o reduce as much as possible the overlap with conformity assessments of 
medical devices covered by a certificate issued by a notifie d body in accordance with  
Directive 93/42/EEC and thereby reduce the burden on notified bodies and the risk of 
shortages of devices, the transitional provisions in Implementing Regulation (EU) 
2022/2346 for products for which clinical investigations are pe rformed or for which a 
notified body has to be involved in the conformity assessment procedure  should be 
extended by 18 and 30 months , respectively .  
(6) The transitional provisions in  Implementing Regulation (EU) 2022/2346  for products 
for which clinical investigations are performed or for which a notified body has to be 
involved in the conformity assessment procedure  apply from 22 June 2023 . In order to 
ensure that those products can benefit directly from the extended tran sitional 
provisions , the relevant provisions of this  Regulation should apply  from the same date . 
Products covered by a certificate issued by a notified body in accordance with 
Directive 93/42/EEC  have benefit ted from  the transitional provisions set out in 
Implementing Regulation (EU) 2022 /2346  from 22 December 2022.  In order to ensure 
that those products can smoothly benefit from the extended transitional provisions and 
considering that the specific conditions set out in this Regulation ensure continuity 
with those previously applicable, the relevant provision of this Regulation should also 
apply from 22 June 2023.  Consequently , the former provision setting out  the 
applicability from 22 December 2022 should be deleted  from Implementing 
Regulation (EU) 2022/2 346 from the date of application of the amended provision set 
out in this Regulation . 
(7) To ensure that economic operators can rapidly  access  and implement the extended 
transitional provisions established by this Regulation, it should be come  applicable 
from the day of its publication in the Official Journal of the European Union . 
(8) Implementing Regulation (EU) 2022/2346 should therefore be amended accordingly.  
(9) The Medical Device Coordination Group has been consulted . 
(10) The measures provided for i n this Regulation are in accordance with the opinion of the 
Committee on Medical Devices , 
HAS ADOPTED THIS REGULATION:  
Article  1 
Implementing Regulation (EU) 2022/2346 is amended as follows:  
(1) Article 2 is amended as follows:  
(a) paragraph 1 is amended as follow s:  
EN 3  EN (i) in the first subparagraph, the date ‘22 June 2028’ is replaced by ‘31 
December 2029’;  
(ii) in the third subparagraph, the date ‘22 June 2026’ is replaced by ‘31 
December 2027’;  
(iii) the fourth subparagraph is replaced by the following:  
‘By way of d erogation from the first subparagraph, from 1 January 2028 
until 31 December 2029, a product that meets the conditions laid down in 
that subparagraph may only be placed on the market or put into service, 
if a written agreement for the performance of the co nformity assessment 
has been signed by the notified body and the manufacturer in accordance 
with Section 4.3, second subparagraph, of Annex VII to Regulation (EU) 
2017/745 .’; 
(b) paragraph 2 is amended as follows:  
(i) in the first subparagraph, the date ‘22 June 2025’ is replaced by ‘31 
December 2028’;  
(ii) the second subparagraph is replaced by the following:  
‘By way of derogation from the first subparagraph, from 1 January 2027 
until 31 December 2028, a product that meets the conditions laid down in 
that su bparagraph may only be placed on the market or put into service, 
if a written agreement for the performance of the conformity assessment 
has been signed by the notified body and the manufacturer in accordance 
with Section 4.3, second subparagraph, of Annex  VII to Regulation (EU) 
2017/745. ’; 
(c) paragraph 3 is replaced by the following:  
‘3. A product  which was covered by a certificate issued by a notified body in 
accordance with Directive 93/42/EEC that expired after 26  May 2021 and 
before 20 March 2023, and fo r which the conditions laid down in Article 
120(2) , second subparagraph,  point (a) or (b), of Regulation (EU) 2017/745 are 
not met, may be placed on the market or put into service until the dates laid 
down in Article 120(3a) of Regulation (EU) 2017/745 , also after the expiry of 
the certificate, provided that  the conditions set out  in Article 120  (3c), (3d) and 
(3e), of Regulation (EU) 2017/745 are met .’; 
(2) in Article 3 (2), the second sentence is deleted . 
Article 2 
This Regulation shall enter into force  on the day of its publication in the Official Journal of 
the European Union . 
It shall apply from 22 June 2023.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN