1 
 Medical Device       
Medical Device Coordination Group Document                           MDCG  2019 -13   
 
 
 
 
 
 
 
MDCG  2019 -13 
        Guidance on sampling of MDR Class  IIa / Class IIb  
        and IVDR Class B / Class C devices  
        for the assessment of the technical documentation
              
 
           Decem ber   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.  
   
2 
 Guidance on s ampling of MDR Class IIa /  
Class IIb and IVDR Class B /  Class C devices 
for the assessment of the technical 
documentation  
1 Introduction  
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation  (EU) 
2017/746 on in vitro  diagnostic medical devices (IVDR)  establish the 
requirements for sampling of Class IIa / Class IIb and Class B /  Class C devices 
for the assessment of the technical documentation.  
Article 52(4) and (6) of the MDR and Article 48( 7) and ( 9) of the IVDR est ablish 
the need to assess the technical documentation of at least one representative 
device per generic device group  (for Class IIb and Class C) and for each 
category of devices  (for Class IIa and Class B) prior to issuing the certificate.   
Section 2.3 and 3.4 of Annex IX of both Regulations (and section 10 of Annex XI  
of the MDR ) defines that the quality management system assessment has to be 
accompanied by the assessment of technical documentation for devices selected 
on a representative basis . 
Section  4.5.2(a) of Annex VII of both Regulations1 requires the notified body to 
draw up and keep up to date, a sampling plan for the assessment of technical 
documentation as referred to in Annexes II and III prior to the audit .  
Section 4.5.2(b) of Annex VII requires the notified body to assess t he technical 
documentation as preparation for the audit (s). This assessment is expected to be 
finalised in due time of such  audit (s). 
 
2 Scope  
This guidance is intended to define  the requirements of sampling for Class IIa 
and Class IIb devices  under the MDR and Class B and Class C devices under 
the IVDR for the purpose of assessing the technical documentation .   
This guidance defines and further elaborates  on the sampling criteria and use of 
such criteria for drawing up  and maintaining a sampling plan.  
In addition, th is guidance clarifies th e tasks to be performed by the notified body 
including the  applicability of Chapter II of Annex IX of both Regulations and the 
extent of  the technical documentation assessment.   
See Section 5.3 for exemptions for specific types of devices.  
 
                                                      
1 Hereafter referred to as “Annex VII”  for both, the MDR and the IVDR.    
3 
 3 Definitions  
The Regulations do not contain definitions of certain terms applicable to 
sampling , and in some instances  certain definitions given cannot be used on an 
operational level. Therefore , only for th e purpose of this  guidance  the 
following definitions apply : 
 
3.1. Category  of devices : category  of devices  should be understood as the 
relevant M DA/MDN codes (MDR) or IV R code s (IVDR)  according to 
Regulation (EU) 2017/2185 on the codes for the designation of notified 
bodies .  
 
3.2. Generic device group2:  is to be understood : 
 in respect of the MDR3,4 as the 4th level of the European 
Nomenclature  on Medical Devices (EMD N) 5, 6 (i.e. combination of 
one letter plus 6 digits ), and  
 in respect of the IVDR as the 3rd level of the EMD N (i.e. 
combination of one letter plus 4 digits respectively)  in combination 
with the most appropriate  IVP code.  
 
3.3. Device  range:  device range is to be understood as all “device 
categories"  for Class IIa and Class B devices and all “generic device 
groups ” for Class IIb and Class C devices  covered in a certificate .   
 
3.4. Device : device should be understood as the device(s) associated with 
one Basic UDI -DI7.  
 
3.5. QMS certificates:  QMS certificates are EU q uality management system 
certificates  (MDR and IVDR) , EU quality assurance certificates  (MDR) 
and EU production quality assurance certificates  (IVDR)  issued by 
notified bodies as a result of conformity assessments .  
 
                                                      
2 "A set of devices having the same or similar intended purposes or a commonality of technology allowing 
them to be classified in a generic manner not reflecting specific characteristics" (Art. 2 (7) MDR  and 
Art. 2(8) IVDR).  
3 In cases, where the 4th level for the MDR do es not exist the notified body should use the next higher 
level . 
4 If the notified body considers that  for a particular device level 4  for the MDR/level 3 for the IVDR is not 
sufficiently specific to define a generic device group, it can use the next lower level if available.  
5EMDN  nomenclature  can be found currently at : 
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_15_file. pdf 
6 In case where more than one EMDN  code applies to one device, only the most appropriate  one of these 
EMD N codes will be assigned for sampling purposes. The technical documentation related to that 
particular device will be assessed in its entirety.  
7 As defined in MDCG 2018 -1 v2 Guidance on BASIC UDI-DI and changes to UDI -DI.  
4 
 4 Sampling criteria  
The Regulation s establish minimum requirements for sampling prior to issuing 
the certificate and during its validity.  The notified body will ensure that these 
requirements  will be complied with when drawing up a sampling plan.  In 
addition, other considerations have to be observed in order to ensure an 
adequate coverage of devices on a representative basis.  
4.1. Quantitative Sampling Criteria  
 
4.1.1.  Sampling prior  to issuing a QMS certificate  
The Regulations establish the need for the notified body to assess technical 
documentation for a number of  devices prior to issu ing the QMS certificate :  
- For Class IIb and Class C the technical documentation of at least one 
representative device per generi c device group  (as per Article 52(4) of the 
MDR and Article 48( 7) of the IVDR ).  This means that the notified body 
shou ld asses s how many generic device groups as per 3.2 are covered in 
the application  (how many nomenclature's 4th levels for MDR /  3rd levels  
in combination with applicable IVP  codes  for the IVDR8), select per group  
at least one representative device covered by a Basic UDI -DI and assess 
the technical documentation  for the device(s) selected .   
- For Class IIa and Class B the technical documentation of at least one 
representative device per category  of devices  (as per Article 52(6) of the 
MDR and Article 48( 9) of the IVDR ).  This means that the notified body 
should asses how many categories of devices as per section 3.1, (how 
many  MDA/M DN or IVR codes ), are covered by the ma nufacturer’s 
application, select per category at least one representative device covered 
by a Basic UDI -DI (MDA/MDN or IVR code ) and assess the technical 
documentation  for the device(s) selected . 
The outcome of these assessments is an essential input for the final review 
according t o Annex VII section 4.7 of the R egulations  prior to issuing of the 
certificate .  
4.1.2.  Sampling during surveillance  
After issuing the certificate, the notified body will continue to assess technical 
documentation in line with the sampling plan. Section 3.5 of Annex IX of both 
Regulations indicates that surveillance assessment shall also include an 
                                                      
8 Generic device groups for Class C devices will consist on an EMDN  + an IVP code. Therefore, when 
different products are covered under the same EMDN  but corresponds to different IVP codes, the 
notified body will assign the most appropriate IVDP code to each device.    
5 
 assessment of the tech nical documentation9 which means that at least one 
technical documentation must  be reviewed each year .  
In addition, notified bodies will ensure that the entire device range is covered 
during the period of validity of the certificates  as required by Section 4.5.2 (a) of 
Annex VII . This means that at least one device per each category, in case of 
Class IIa and Class B  devices , and at least one device per each generic device 
group, in case of Class IIb and Class C devices, should be samp led and the 
relevant technical documentation assessed between the issue of a certificate 
and its expiry date.  
Furthermore, in addition to  the above -mentioned criteria , the number of samples  
to be assessed need to be selected on a representative basis ( as per Annex VII 
4.5.1 9th indent MDR, An nex IX 2.3  3rd paragraph MDR / IVDR,  and An nex VII 
4.5.1 8th indent IVDR). Therefore, in developing the sampling plan (see section 
6), the notified body should also ensure that the number of devices sampled is 
proportionate to the total number of devices contained in the certificate. For this 
purpose, it is expected that 15%10 of devices from  each category and from each 
generic device group covered in the certificate will be sampled during its validity  
– taking into account the maximum validity of 5 years . 
In cases where the certificate contains very few devices and the technical 
documentation s of these have been already reviewed, it is expected that during 
surveillance audit s the notified body will focus on the review of the technical 
documentation related to post -market surveillance in accordance with Annex III .  
Normally, the devices to be sampled after the certificate has been issued would 
be spread evenly during the validity of the certificate. However, the notified body 
might decide to perform different number s of reviews in a given year for different 
reasons (e.g. workload , vigilance concern ) as long as throughout the surveillance 
period all initially determined assessments are performed . Such an approach is 
acceptable as long as the minimum requirements mentioned in the first 
paragraph of this section are complied with.  
4.2. Qualitative  Sampling Criteria  
Section 2.3 of Annex IX of both Regulations establishes qualitative criteria to be 
used when drawing up sampling plans. While s ome of these criteria such as 
similarities in design, technology and manufacturing and sterilisation methods 
may be covered already by the fact that devices belong to the same category or 
generic device group , all the criteria defined in Section 2.3 of Annex IX including  
novelty of the technology  intended purpose  or the results of any previous 
relevant assessments such as with regard to physical, chemi cal, biological or 
clinical properties must be individually considered when prioritising the review of 
one device over another.  This prioritisation should take into account the inherent 
risk of  the different devices included in the relevant category  of devices  / generic 
                                                      
9 The follow -up of change notifications according to Section 4.9 of Annex VII (e.g. “the device range 
covered” in Annex IX section 2.4), and other surveillance activities as laid down in Section 4.10 of 
Annex VII are to be carried out in addition to sampling during surveillance . 
10 For the first certification cycle under the MDR/IVDR the 15% may be decreased to a minimum of 5%.   
6 
 device group which means that , for instance, novel devices, will usually  be 
prioritised over well -known technologies (unless there are specific concerns over 
the latter).  Additional criteria may be also taken into consideration by the  notified 
body11. As required by the Regulation, the notified body must  document its 
rationale for the samples taken , in particular, mentioning what specific criteria 
have been taken into account.  
It should be noted, that as long as there are devices that have  not been sampled , 
each device should only be sampled once  during the period of validity of the 
certificate  unless vigilance cases or other information which  have been brought 
to the notified body ’s attention will require it .  
 
5 Assessment of the technical documentation  
 
5.1. Depth of the assessment  
The depth and extent of the technical documentation assessment of Class IIa / 
IIb and Class B / Class C devices will be the same as the  depth of assessment 
carried out for Class III and Class IIb implantable  and Class D devices .  
This means that the technical documentation of a device shall be assessed 
against all General Safety and Performance Requirements (Annex I) and 
requirements of Annex II and III. Records of the assessment shall be prepared 
which allow  a third party to understand the functionality of the device and all 
aspects of the assessment including judgements made by the assessor . 
It should be taken into account that every device (i.e. Basic UDI -DI) might include 
different variants, models or sizes. In that case, the review of the technical 
documentation will also include the assessment of how the differences among 
these have been addressed in the technical documentation and whether all of 
them are in line with the relevant requirements.  
5.2. Applicability of Chapter II, Section 4 of Annex IX   
Taking into account the wording of article s 52(4) and 52(6) of the MDR and 
Article 48(7) and 48(9) of the IVDR, as combined with annex es VII and IX, the 
tasks to be carried out by the notified body as part of the conformity assessment 
activities described in Chapter II , Section 4  of Annex IX comprise t he complete 
review of the technical documentation  in accordance with Annexes II and III .  
In addition, the manufacturer  will grant access to the technical documentation as 
referred to in Section 2.2 of Annex IX and the  notified body will  provide the 
manufacturer with a report on the technical documentation assessment. For 
Class IIa / IIb and Class B / Class C the notified body will neither require  an 
application nor issue an EU technical documentation assessment certificate  (see 
5.3 for exceptions) .  
                                                      
11 For instance, where controls or calibrators are specifically intended to be used in conjunction with a  
specific IVD device, these controls or calibrators will preferably be assessed alongside that device   
7 
 5.3. Additional requirements for s pecific types of devices under the MDR 
and the  IVDR  
For class IIb  implantable devices12, Article 52(4) second subparagraph  of the 
MDR establish es the need to review the technical documentation in accordance 
with the complete Section 4 of Annex IX for every device,  therefore  an 
application as well as the issuance of an EU technical documentation 
assessment certificate  are req uired . They are exempt from sampling.  
According to Article 54 , Class IIb active devices intended to administer and/or 
remove a medicinal product falling into rule 12 of Annex VIII are subject to the 
clinical evaluation consultation procedure  prior to issuing of the certificate . These 
devices can be subject to sampling  but according to Article s 54(3) and 55 the 
notified body must ensure that at least the clinical evaluation assessment report 
(CEAR) for each device  is uploaded in Eudamed prior to issuing the QMS 
certificate.   This means that the sampling will not apply to the clinical evaluation 
as it has to be assessed for every device.  
Article 48  (7, 8 and 9) and Section 5 of Annex IX of the  IVDR establish  that class 
B and C devices for self -testing, near-patient testing  and companion diagnostics 
are exempt from sampling . The manufacturer will lodge an application as per 
sections 5.1  (a) and 5.2 (a) of Annex IX of the IVDR , and , as described in section 
5.1 (c-e) and 5.2 ( a-e), the notified bod y will review the technical documentation 
of all the devices covered in the certificate  and will issue an EU technical 
documentation assessment certificate.   
5.4. Reporting  
The technical documentation assessment of Class IIa / IIb and Class B /  Class C  
devices and its reporting should follow the principles established in Annex VII 
and the applicable provisions of the conformity assessment annexes  and should 
use or be similar to those procedures and checklists developed by the notified 
body for the assessment of Class III / IIb implantable devices  and Class D 
devices .  
In order to fulfil the legal requirements, the reporting requirements established in 
Section 4.6. of Annex VII will apply.  
 
6 Drawing up and keeping up to date a sampling plan  
According to Section 4.5.2(a) of Annex VII  the notified body shall draw up and 
keep up to date a sampling plan . This plan should contain at least the devices  
covered by the certificate, their Basic UDI -DI, the generic device group (in case 
of Class IIb ), the generic device group plus the IVP code (in case of  Class C 
devices) or the category of devices (in case of Class IIa / Class B devices) , the 
identifier of the respective technical documentation , the (planned) assessment 
dates and the status of such asse ssments .  
                                                      
12 Except fo r sutures, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips 
and connectors,  which are subject to sampling   
8 
  
The notified body should update the sampling plan whenever needed on the 
basis of the criteria defined in this guidance  as well as on the basis of its post -
certification activities laid down in Section 4.10 of Annex VII. In particular, the 
outco me of the screening of relevant sources of scientific and clinical data and 
post-market information relating to the scope of their designation , or the review of 
vigilance data should be taken into account.  
If the manufacturer makes a change in the product range during the period of 
validity of the certificate, the notified body should review the sampling plan 
accordingly. When a dding new devices to the scope of the certificate which do 
not fall into the alrea dy covered generic device groups / categories  of devices , 
the initial sampling criteria (section 4.1) apply.  
If the manufacturer applies for re -certification, the notified body should update 
the sampling plan with the samples to be assessed during the upc oming 
certification period according to the principles laid down under section 4.1.2 
Sampling during surveillance and keep the sampling plan up to date as 
described above.