Medical Devices       
Medical Devices Coordination Group Document   MDCG  201 9-2   
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MDCG  201 9-2    
 Guidance on application of UDI rules to  
 device -part of products referred to in Article 
 1(8), 1(9) and 1(10) of Regulation 745/2017  
                 
 
 
 February 2019  
 
 
  
 
 
 
 
This document has been endorsed by the Medical Device Coordination Group 
(MDCG) established by Article 103 of Regulation (EU) 2017/745.  The MDCG is 
composed of representatives of all Member States and it is chaired by a 
representative of the European Commission.  
The document is not a European Commission document and it cannot be regarded 
as reflecting the official position of the European  Commission. Any views expressed 
in this document are not legally binding and only the Court of Justice of the European 
Union can give binding interpretations of Union law.  Medical Devices       
Medical Devices Coordination Group Document   MDCG  201 9-2   
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1. Scope  
Article 1(8),1(9), 1(10) of the Medical Device Regulation (EU) 2017/745 (MDR) set 
the basic criteria to determine whether and to what extent the relevant legislation on 
medical devices, medicinal products, human tissue and cells apply to certain 
products c ontaining a medical device part. In particular,  
“8. Any device which, when placed on the market or put into service, incorporates, as 
an integral part, a substance which, if used separately, would be considered to be a 
medicinal product as defined in poin t 2 of Article 1 of Directive 2001/83/EC, including 
a medicinal product derived from human blood or human plasma as defined in point 
10 of Article 1 of that Directive, and that has an action ancillary to that of the device, 
shall be assessed and authorised  in accordance with this Regulation.  
However, if the action of that substance is principal and not ancillary to that of the 
device, the integral product shall be governed by Directive 2001/83/EC or Regulation 
(EC) No 726/2004 of the European Parliament an d of the Council, as applicable. In 
that case, the relevant general safety and performance requirements set out in Annex 
I to this Regulation shall apply as far as the safety and performance of the device part 
are concerned.  
9. Any device which is intende d to administer a medicinal product as defined in point 
2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without 
prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with 
regard to the medicinal produ ct.  
However, if the device intended to administer a medicinal product and the medicinal 
product are placed on the market in such a way that they form a single integral 
product which is intended exclusively for use in the given combination and which is 
not reusable, that single integral product shall be governed by Directive 2001/83/EC 
or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general 
safety and performance requirements set out in Annex I to this Regulation shall apply 
as far  as the safety and performance of the device part of the single integral product 
are concerned.”  
10. Any device which, when placed on the market or put into service, incorporates, as 
an integral part, non -viable tissues or cells of human origin or their de rivatives that 
have an action ancillary to that of the device shall be assessed and authorised in 
accordance with this Regulation. In that case, the provisions for donation, 
procurement and testing laid down in Directive 2004/23/EC shall apply.  
However, if the action of those tissues or cells or their derivatives is principal and not 
ancillary to that of the device and the product is not governed by Regulation (EC) No 
1394/2007, the product shall be governed by Directive 2004/23/EC. In that case,  the 
relevant general safety and performance requirements set out in Annex I to this 
Regulation shall apply as far as the safety and performance of the device part are 
concerned”.  
 Medical Devices       
Medical Devices Coordination Group Document   MDCG  201 9-2   
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2. Application to UDI rules to the device part of products referred to in 
point 1 that are governed by the medical device Regulations  
EXAMPLES:  
- Catheters coated with heparin or an antibiotic  
- Soft tissue fillers incorporating local anaesthetics  
- Implantable infusion pump  
- Spacer devices for use with metered dose inhalers  
- Bone void  filler with an antibiotic  
- Bone void filler with animal growth factors, where the action of the growth 
factors is demonstrated to be ancillary to that of the physical filler  
If a product referred to in point 1 is assessed and authorised in accordance with  the 
Medical device regulations, the device part will be subject to all UDI -related 
obligations.  
3. Application to UDI rules to the device part of combination products that 
do not fall under the medical device Regulations  
EXAMPLES:  
- Non-reusable autoinjectors  containing a medicinal product as integral part  
- Nebulizers precharged with a specific medicinal product  
- Patches for transdermal drug delivery  
- Wound dressings impregnated with an antibiotic, where the primary intended 
purpose is to administer the antibioti c to the wound  
- Bone void filler with animal growth factors, where the action of the growth 
factors cannot be demonstrated to be ancillary to that of the physical filler  
In general terms, if a product referred to in point 1 is governed by the medicinal 
product or tissue and cell legislation, the device part is required to comply only with 
the relevant general safety and performance requirements set out in Annex I to the 
Regulation on medical devices. This cannot be interpreted as meaning that the 
relevant o bligations related to UDI, as laid down in Chapter III and Annex VI of the 
Regulation on medical devices, apply to the medical device part or the package of 
the relevant combination. For this reason, the medical device part is not mandatorily 
required to c omply with any UDI -related obligation. This also means that a UDI is not 
needed on the package that combines the medicinal product and the medical device1 2. 
                                                           
1  However,  if the medical device part bears a UDI on its label, that should not be deemed as being in contrast with the 
applicable medical device legislation  
2  For products such as prefilled syringes which are made on the b asis of a UDI direct part marked (MDR compliant) 
syringe it shall be noted that, while UDI rules do not apply to the device part of the integral product, the direct mark 
UDI on the syringe shall not be removed unless that mark compromises the safety and pe rformance of the integral 
product.