Medical Device       
Medical Device Coordination Group Document   MDCG  2020-5  
 
  
 
 
 
MDCG 2020-5 
  
 Clinical Evaluation - Equivalence 
A guide for manufacturers and notified bodies 
               
 
 April 2020 
 
 
  
 
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. 
   
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Clinical Evaluation - Equivalence  
A guide for manufacturers and notified bodies  
   
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 1 Table of contents 
 
1. Introduction .......................................................................................................... 4 
2. Scope ................................................................................................................... 5 
3. Equivalence ......................................................................................................... 5 
3.1 Technical characteristics ............................................................................... 5 
3.2 Biological characteristics ............................................................................... 6 
3.3 Clinical characteristics ................................................................................... 9 
4. Demonstration of equivalence ............................................................................ 10 
5. Use of data from similar devices ........................................................................ 14 
6. Clinical data identification ................................................................................... 15 
Annex I – Equivalence table ..................................................................................... 16 
 
   
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 1. Introduction 
 
This guidance document is not legally binding. It has been put together following 
contribution from national competent authorities, industry and relevant stakeholders 
and it should therefore be recognised as best practice.  
The Regulation (EU) 2017/745 on medical devices1, hereafter referred to as the MDR 
(medical device regulation), provides a possibility to use clinical data related to an 
equivalent device in the clinical evaluation required for a device under conformity 
assessment2. 
Whilst carrying out a clinical investigation is the most direct way to generate clinical 
data concerning the safety and performance of medical devices for the purpose of CE 
marking, clinical data can also be sourced from3 
 clinical investigation(s) or other studies reported in scientific literature, of a 
device for which equivalence to the device in question can be demonstrated, 
 reports published in peer reviewed scientific literature on other clinical 
experience of either the device in question or a device for which equivalence to 
the device in question can be demonstrated 
 
Equivalence shall be demonstrated according to the MDR requirements4. 
The European Commission has published a guide on clinical evaluation under the 
directives 93/42/EEC and 90/385/EEC; MEDDEV 2.7/1 rev. 45. This MEDDEV guide 
should be used also during the process of demonstrating equivalence under the MDR. 
However, it has been recognised that some of the requirements set out in MEDDEV 
2.7/1 rev. 4 are not fully aligned with the MDR and that further guidance to address the 
differences would be of benefit to industry and other stakeholders. Only the text of the 
MDR is legally binding. In cases of divergence between the MEDDEV 2.7/1 rev. 4, this 
MDCG guidance and the MDR, the MDR shall take precedence. 
This MDCG guidance does not introduce any new requirements. 
The demonstration of equivalence does not remove the requirement to always conduct 
a clinical evaluation in accordance with the MDR. It is the demonstration of 
equivalence6 that allows the manufacturer to let clinical data from an equivalent device 
enter the clinical evaluation process of the device in question for the purpose of 
confirmation of conformity with relevant general safety and performance 
                                                             
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices 
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC   
2 MDR, Article 61 and Annex XIV Part A. 
3 MDR, Article 2 (48) 2nd and 3rd indent. 
4 MDR, Annex XIV, Part A (3). 
5 MEDDEV 2.7/1 revision 4, Guidelines on medical devices, clinical evaluation: A guide for manufacturers and 
notified bodies under directives 93/42/EEC and 90/385/EEC 
https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en   
6 MDR, Annex XIV, Part A (3).  
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 requirements7. There may also be other sources of clinical data than from an 
equivalent device8 to include in the process of clinical evaluation. 
2. Scope 
This MDCG guidance covers the demonstration of equivalence, based on data 
pertaining to an already existing device on the market9, for the purpose of CE-marking 
under the MDR.  
One of the purposes of this document is to highlight the differences between the MDR 
and the MEDDEV 2.7/1 rev.4 specifically with regards to equivalence. It is also 
intended to provide additional guidance and support a harmonised approach to the 
demonstration of equivalence across the EU. 
In addition, non-exhaustive guidance and references have been provided with respect 
to device considerations for medical devices incorporating an ancillary medicinal 
product.  
This MDCG guidance also covers products without an intended medical purpose listed 
in Annex XVI of the MDR. 
3. Equivalence  
The MDR requires10 that technical, biological and clinical characteristics are 
considered when demonstrating equivalence to another device. Whilst these general 
characteristics are described in the MEDDEV 2.7/1 rev. 4 Appendix 1 and are aligned 
with the MDR requirement, there are differences in the criteria that are set out for each 
of the three characteristics. Differences in criteria between the MDR and the MEDDEV 
2.7/1 rev. 4 are highlighted below and are accompanied by some explanatory text.  
3.1 Technical characteristics 
 
MDR, Annex XIV Part A (3) MEDDEV 2.7/1 rev 4, Appendix A1 
The device is of similar design;  
is used under similar conditions of use ;  
has similar specifications and properties including 
physicochemical properties such as intensity of 
energy, tensile strength, viscosity, surface 
characteristics, wavelength and software 
algorithms ;  
uses similar deployment methods, where relevant;  
has similar principles of operation and critical 
performance requirements. - be of similar design, and 
- used under the same conditions of use , and 
- have similar specifications and properties (e.g. 
physicochemical properties such as type and intensity 
of energy, tensile strength, viscosity, surface 
characteristics, wavelength, 
surface texture, porosity, particle size, nanotechnology, 
specific mass, atomic inclusions such as 
nitrocarburising, oxidability), and 
- use similar deployment methods (if relevant), and 
- have similar principles of operation and critical 
performance requirements 
 
                                                             
7 MDR, Article 61 (1) and (3 (a)). 
8 MDR, Article 2 (48) 1st and 4th indent. 
9 Whether the ‘market’ is presumed to be the EU market or not is related to requirements in Article 61. See 
section 4 (d) and (e) in this document for further guidance. 
10 MDR, Annex XIV Part A (3).  
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 (a) The MDR requires that technical characteristics shall be taken into 
consideration for the demonstration of equivalence including that the device in 
question and the device presumed to be equivalent are “used under similar 
conditions of use”. MEDDEV 2.7/1 rev. 4, however, specifies use under the 
same conditions with regard to technical characteristics11. The conditions of use 
shall be similar to the extent that there would be no clinically significant 
difference in the safety and clinical performance between the device in question 
and the device presumed to be equivalent. For further guidance on the 
assessment of ‘similar’, see also section 4 of this document.  
 
(b) Different examples are given for specifications and properties of the device 
when considering technical characteristics across the two definitions. These are 
examples only and are to be considered as such. They must not be interpreted 
as an exhaustive list of specifications and properties of technical characteristics 
when considering equivalence to another device. Note however that the MDR 
specifically points out that software algorithms  shall be similar in the device 
presumed to be equivalent. This includes software algorithms in software driving 
or influencing the use of a device, and in software intended to be used alone12. 
It is the functional principle of the software algorithm, as well as the clinical 
performance(s) and intended purpose(s) of the software algorithm, that shall be 
considered when demonstrating the equivalence of a software algorithm. It is 
not reasonable to demand that equivalence is demonstrated for the software 
code, provided it has been developed in line with international standards for 
safe design and validation13 of medical device software. 
 
Software solely intended for the configuration of a device (e.g. presentation on 
a graphical user interface etc), and not related to any medical purpose14  (e.g. 
diagnosis, treatment etc), does not need to be similar when considering 
equivalence as long as it can be justified to not negatively affect the usability, 
safety or clinical performance. 
3.2 Biological characteristics  
 
MDR, Annex XIV Part A (3) MEDDEV 2.7/1 rev. 4, Appendix A1 
The device uses the same materials or substances in 
contact with the same human tissues or body fluids 
for a similar kind and duration of contact and 
similar release characteristics of substances, 
including degradation products and leachables  
 Use the same materials or substances in contact with 
the same human tissues or body fluids. 
Exceptions  can be foreseen for devices in contact 
with intact skin and minor components of devices; in 
these cases risk analysis results may allow the use of 
similar materials taking into account the role and 
nature of the similar material. 
                                                             
11 “Conditions of use” with regard to technical characteristics may e.g. be environmental factors such as 
magnetic fields, temperature, moisture, conditions during transport of device in use etc.  
See section 3.3 in this document regarding use for the same clinical condition or purpose. 
12 See MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - 
MDR and Regulation (EU) 2017/746 – IVDR. 
13 E.g. IEC 62304 Medical device software – Software life cycle processes, and IEC 82304-1 Health software – 
Part 1: General requirements for product safety. 
14 MDR, Article 2(1).  
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 (a) Manufacturers must consider the additional text in the MDR and adequately 
specify all applicable characteristics. The exceptions, outlined in the MEDDEV 
2.7/1 rev 4, to not use the same materials are NOT acceptable under the MDR. 
 
The MDR requires that biological characteristics shall be taken into 
consideration for the demonstration of equivalence, i.e. the device uses the 
same materials or substances  in contact with the same human tissues or body 
fluids for a similar kind and duration of contact, and with similar release 
characteristics of substances, including degradation products and leachables, 
as the presumed equivalent device. The distinction between “same materials or 
substances” and “similar release characteristics of substances” is made to 
account for the fact that processing, design and the use environment may 
introduce small changes even when the raw materials are the same.  
 
Processing can make materials more susceptible to degradation by changing 
properties of the material and/or by inducing different stresses. For example, 
small changes in pH or oxidative stress can increase or decrease release 
characteristics. For this reason, it is the final device that shall be assessed. 
 
(b) The principles outlined in ISO 10993 series of standards for the biological 
evaluation of medical devices can be adopted, in particular the ISO 10993-1 for 
a risk-based approach to biological evaluation15 and also for material 
characterization.  
 
In addition, the ISO 10993-18 which covers chemical characterization of 
materials can be adopted to specify the identity of materials and to estimate the 
type and quantity of leachables from the final device.  Annex C of this standard 
addresses biological equivalence. The ISO 10993-17 includes principles on the 
toxicological risk assessment of leachables. Leachables may include 
degradation products or other substances from the materials or substances that 
the device is made of, but also other constituents for example residuals from 
the manufacturing process or sterilisation, any contaminations etc. Therefore, 
for the consideration of equivalence, it is the properties and characteristics of 
the final device that shall be taken into account. 
 
For degradable materials, ISO 10993, Parts 13, 14 and 15 address the 
identification and quantification of degradation products. Note, that there may 
be further parts in the ISO 10993 series of standards that are relevant for the 
device in question.  
 
(c) The MDR has additional requirements16 for devices that are composed of 
substances or of combinations of substances  that are intended to be 
introduced into the human body, and that are absorbed by or locally dispersed 
                                                             
15 ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk 
management process, and collateral standards in the 10993 series. 
16 MDR, Annex I, (12.2).  
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 in the human body. For the consideration of equivalence, the substances shall 
be the same. 
 
Those devices are not medicinal products, but for the conformity assessment 
they shall comply with the relevant requirements laid down in Annex I to 
Directive 2001/83/EC17 for the evaluation of absorption, distribution, 
metabolism, excretion, local tolerance, toxicity, interaction with other devices, 
medicinal products or other substances and potential for adverse reactions. This 
means that for the demonstration of equivalence under the MDR, those aspects 
shall also be taken into consideration. 
 
Note that the requirement18 that the notified body shall seek a scientific opinion 
from a competent authority for medicinal products or the EMA, for the device or 
its products of metabolism, that are systemically absorbed by the human body 
in order to achieve their intended purpose, on the compliance with the relevant 
requirements laid down in Annex I to Directive 2001/83/EC, always applies for 
the device under evaluation even if equivalence has been demonstrated under 
the MDR. 
 
(d) The demonstration of equivalence may also concern medical devices with an 
ancillary medicinal substance , for example drug-eluting stents or heparin-
bonded central venous catheters.  
 
The MDR requires19 that biological characteristics shall be taken into 
consideration for the demonstration of equivalence, including that the device in 
question and the device presumed to be equivalent, use “the same materials or 
substances in contact with the same human tissues or body fluids”. This applies 
also to the medicinal substance and any related excipients/coatings.  
 
Excipients/coatings may potentially have a significant effect for example on the 
release characteristics of the medicinal substance intended only for a local 
effect from a stent, and thereby a significant effect on the clinical performance. 
 
In all cases, concerning the device under evaluation, the notified body shall20   
 verify the usefulness of the substance as part of the device, taking 
account of the intended purpose of the device, and 
 seek a scientific opinion from a competent authority for medicinal 
products or the EMA to ensure that the quality, safety and benefit/risk of 
using the ancillary medicinal product, including whether the 
manufacturing process have been adequately assessed. 
 
                                                             
17 Directive 2001/83/EC relating to medicinal products for human use. 
18 MDR, Annex IX, Chapter II, 5.4 (b). 
19 MDR, Annex XIV Part A (3)  second indent. 
20 MDR, Annex IX, Chapter II, 5.2. (b) and (c).  
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 Note that medical devices with an ancillary medicinal substance are class III 
devices21. In cases where a manufacturer intends to claim equivalence to a 
device not manufactured by him, the MDR requires that the two manufacturers 
have a contract in place that explicitly allows the manufacturer of the second 
device full access to the technical documentation on an ongoing basis22 . 
 
Manufacturers cannot claim equivalence of a device with an ancillary medicinal 
substance to a device without an ancillary medicinal substance and vice versa. 
For example, the manufacturer of a heparin coated catheter shall not claim 
equivalence to a drug-free catheter even if both catheters are otherwise 
identical23 . See also section 4 of this document.  
 
Similarly, manufacturers shall not claim equivalence of the ancillary medicinal 
substance to a ‘standalone’ medicinal substance. 
 
3.3 Clinical characteristics 
 
MDR, Annex XIV Part A (3)  MEDDEV 2.7/1 rev . 4, Appendix A1  
The device is used for the same clinical condition or 
purpose , including similar severity and stage of 
disease, at the same site in the body, in a similar 
population, including as regards age, anatomy and 
physiology;  
has the same kind of user ;  
has similar relevant critical performance in view of the 
expected clinical effect for a specific intended 
purpose. - used for the same clinical condition (including when 
applicable similar severity and stage of disease, same 
medical indication ), and 
- used for the same intended purpose, and 
- used at the same site in the body, and 
- used in a similar population (this may relate to age, 
gender, anatomy, physiology, possibly other aspects), 
and 
- not foreseen to deliver significantly different 
performances (in the relevant critical performances such 
as the expected clinical effect, the specific intended 
purpose, the duration of use , etc.) 
 
(a) The MDR additionally requires that, for manufacturers to compare clinical 
characteristics, the device shall have the same kind of user . The MDR clearly 
points out that a user means any healthcare professional or lay person who 
uses a device24, and that a lay person means an individual who does not have 
formal education in a relevant field of healthcare or medical discipline25. 
Manufacturers must therefore take into consideration whether the intended 
user’s competence or knowledge can have any implication for the safety, clinical 
performance and outcome when considering equivalence between the device 
in question and the presumed equivalent device. For example, a device 
intended for professional use and a device intended for home use, but for the 
same clinical condition or purpose, may have a different safety and performance 
profile due to the environment in which they are intended to be used.  
                                                             
21 MDR, Annex VIII, Rule 14. 
22 MDR, Article 61 (5). 
23 MDR, Annex XIV Part A (3). 
24 MDR, Article 2 (37). 
25 MDR, Article 2 (38).  
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(b) The MDR does not explicitly state that the medical device needs to be used for 
the same medical indication, gender and duration of use  as the equivalent 
device. However, it is understood that in general, this is covered by the MDR 
requirement that both devices should be used for the same clinical condition 
or purpose  including similar severity and stage of disease and also have similar 
relevant critical performance which is also outlined in the MEDDEV 2.7/1 rev. 4. 
This is supported by the definitions in the MDR of the ‘intended purpose’26, and 
the ability of the device to achieve its intended purpose by the ‘clinical 
performance’27 including measurable ‘clinical benefit’28.  
4. Demonstration of equivalence   
 
MDR, Annex XIV Part A (3) MEDDEV 2.7/1 rev. 4, Appendix A1 
The characteristics listed in the first paragraph shall be 
similar to the extent that there would be no clinically 
significant difference in the safety and clinical 
performance of the device. Considerations of 
equivalence shall be based on proper scientific 
justification .  
 For assuming equivalence, 
- all three characteristics (clinical, technical, biological) 
need to be fulfilled; 
- similar means that no clinically significant difference 
in the performance and safety of the device would be 
triggered by the differences between the device under 
evaluation and the device presumed to be equivalent. 
 
There are a number of prerequisites that shall be fulfilled for the demonstration of 
equivalence: 
(a) The overall considerations of equivalence shall conclude whether the listed 
technical, biological and clinical characteristics in the MDR29 are similar to the 
extent that there would be no clinically significant difference in the safety and 
clinical performance of the device. Note that some of the listed characteristics 
in the MDR shall be the same, not only similar. The corresponding wording from 
MEDDEV 2.7/1 rev. 4 is presented for information above. Consideration must 
be given to the characteristics mentioned above and a gap analysis should be 
conducted by the manufacturer to evaluate any clinically significant 
difference(s). 
Modifications30 of a device may be implemented for a variety of reasons. If the 
differences have been introduced to address specific safety and/or performance 
issues it shall be duly justified, that there would be no clinically significant 
difference in the safety and clinical performance other than the intended 
improvements related to the specific issue that triggered the modification / 
difference. For all modifications and concomitant claims of equivalence, there 
must be no additional risks or potential of negatively altered performance related 
to the introduced modifications. 
                                                             
26 MDR, Article 2 (12). 
27 MDR, Article 2 (52). 
28 MDR, Article 2 (53). 
29 MDR, Annex XIV Part A (3). 
30 MDR, Article 61 (4).  
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 See a template example of an Equivalence table in the Annex I of this document. 
 
A manufacturer of a medical device shall not claim equivalence to a product 
without an intended medical purpose listed in the MDR Annex XVI. 
 
(b) Manufacturers may identify more than one equivalent device to the device under 
evaluation, but each device shall be equivalent to the device under evaluation 
in all the listed technical, biological and clinical characteristics31. Equivalence to 
each device shall be fully investigated, described and demonstrated in the 
clinical evaluation report.  
This means that manufacturers shall not use different parts of different devices 
to claim equivalence to the device under evaluation. The MEDDEV 2.7/1 rev. 4 
is in line with this approach. 
In exceptional cases, a deviation from this principle may be considered. There 
may be device systems comprised of several more or less “stand alone” 
devices, where it may be justified to consider equivalence of a device in the 
system to a presumed equivalent device in a device system already on the 
market (by the same manufacturer) provided that all technical, biological and 
clinical characteristics are same/similar32, and that the devices in the system do 
not affect the safety and performance of each other. This should be duly 
investigated and documented both on the level of potential interference between 
the devices in the system, as well as on the overall safety and clinical 
performance of the device system. 
 
(c) Regarding the clinical evaluation, the MDR requires33 that the manufacturer 
shall specify and justify the level of clinical evidence necessary to demonstrate 
conformity with the relevant general safety and performance requirements. That 
level of clinical evidence shall be appropriate in view of the characteristics of the 
device and its intended purpose34. In addition, considerations of equivalence 
shall be based on proper scientific justification35.  
 
This implies that technical, biological and clinical characteristics shall be duly 
investigated and documented. The manufacturer is expected to fully identify and 
disclose any differences between the two devices.  
 
Pre-clinical data for the consideration of equivalence should allow a scientifically 
sound evaluation of technical and biological characteristics. Examples of data 
sources: 
                                                             
31 MDR, Annex XIV Part A (3), the requirement refers to only “a device” and “the device”. 
32 MDR, Annex XIV Part A (3). 
33 MDR, Article 61 (1) second paragraph. 
34 MDR, Article 61 (1) second paragraph  
It may under certain circumstances be justified to demonstrate conformity without support of clinical data, see 
MDR, Article 61 (10), but note that this is not applicable for implantable devices or class III devices. 
35 MDR, Annex XIV Part A (3) 
For guidance see also MEDDEV 2.7/1 rev 4, Annex A6, Appraisal of clinical data - examples of studies that lack 
scientific validity for demonstration of adequate clinical performance and/or clinical safety.  
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  data from the technical documentation of a manufacturer’s own 
presumed equivalent device (specifications, test-results, 
chemical/physical/biological analyses, data from pre-clinical 
investigations etc) 
 data published in the scientific literature, e.g. animal or other pre-clinical 
data 
The assessment of whether any differences in characteristics would result in 
clinically significant difference in safety and clinical performance shall also be 
duly substantiated and based on proper scientific justification. This assessment 
may be supported by e.g. clinical data from the scientific literature, common 
specifications (CS)36, harmonised standards or other established technical 
specifications. 
Furthermore, for the assessment of safety, a risk-based approach37 is expected, 
both for the identification of characteristics that may affect safety as well as for 
the final assessment of equivalence regarding safety. 
 
It is important for the consideration of equivalence that pre-clinical data and any 
clinical data relate to the actual device under evaluation, and to a defined 
generation/version of the actual device considered for equivalence, bearing in 
mind that there may be significant differences between different generations of 
the other device.   
 
If a manufacturer is not able to demonstrate sufficient levels of access to the 
data38 relating to the presumed equivalent device and needed for the 
consideration of equivalence, equivalence claims cannot be made for the 
purpose of conformity assessment. 
 
(d) The MDR notes specific requirements in addition to the demonstration of 
equivalence in order not to perform a clinical investigation which must be taken 
into account. 
 
A manufacturer of implantable devices and class III devices  shall perform 
clinical investigations except if the device has been designed by modifications 
of a device already marketed by the same manufacturer  and equivalence can 
be demonstrated according to the MDR39. In this context, a marketed device is 
considered to be a device already placed on the market and CE marked with 
respect to either the MDR or the directives 93/42/EEC or 90/385/EEC. The CE 
marking should still be valid, should be based on an updated clinical evaluation, 
and the benefit/risk ratio for this device should be favourable. 
 
                                                             
36 MDR, Article 2, (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other 
than a standard, that provides a means of complying with the legal obligations applicable to a device, process or 
system. 
37 ISO 14971 Medical devices – Application of risk management to medical devices, and also other related 
standards as applicable e.g. ISO 10993-1 and ISO 10993-18. 
38 MDR, Annex XIV Part A (3) last paragraph. 
39 MDR, Article 61 (4), and Annex XIV (3).  
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 For a manufacturer of implantable devices and class III devices  claiming 
equivalence to an already marketed device not manufactured by him , in 
addition to the requirements in MDR Article 61(4), the manufacturer must have 
a contract in place that allows full access to the technical documentation on an 
ongoing basis40. Furthermore, the MDR also requires that the original clinical 
evaluation of the equivalent device has been performed in compliance with the 
requirements of the MDR. This implies that the presumed equivalent device is 
certified under the MDR. As such, it will not be possible to claim equivalence to 
a device certified with respect to the Directives 93/42/EEC or 90/385/EEC. 
(e) For devices other than implantable devices and class III devices  and where 
the manufacturer wants to claim equivalence, MDR Article 61 (3) is applicable. 
This requirement does not specify whether the device is presumed to be 
marketed within the EU. Therefore, it will be possible to claim equivalence to a 
device certified with respect to the Directives 93/42/EEC or 90/385/EEC or the 
MDR.  
However, exceptions can be considered, and equivalence claimed to a device 
that is not CE-marked, provided all relevant MDR requirements regarding 
equivalence and clinical evaluation can be met. This includes  
 that the manufacturer shall have sufficient levels of access to the data 
relating to devices with which they are claiming equivalence41 . In the 
circumstance that the presumed equivalent device is from another 
manufacturer, there is no MDR requirement of a contract between the 
manufacturers for regulating the access to the technical documentation. 
 that clinical investigations were conducted in accordance with 
international guidelines42  
 that the clinical data meet the requirements of the MDR, and a 
justification is provided whether the clinical data are transferrable to the 
European population.  
The regulatory status of the presumed equivalent device should be disclosed. 
See MEDDEV 2.7/1 rev. 4 Appendix A1 for further guidance.  
 
(f) In case of products without an intended medical purpose  listed in MDR 
Annex XVI clinical investigations shall be performed for those products unless 
reliance on existing clinical data from an analogous medical device is duly 
justified43. An analogous device, in this context, is understood as a medical 
device which is similar in terms of functioning and risks profile and has a medical 
purpose44. To duly justify reliance on existing clinical data from an analogous 
                                                             
40 MDR, Article 61 (5). 
41 MDR, Annex XIV Part A (3) the last sentence. 
42 MDR, Recital (64) 
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155), and 
World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human 
Subjects. 
43 MDR, Article 61 (9). 
44 MDR, Recital (12).  
Page 14 of 20 
 medical device, the principles of demonstration of equivalence45 should be 
applied with the acceptance that the device under evaluation will only have an 
aesthetic or another non-medical purpose whereas the analogous device has a 
medical purpose. The general requirement to demonstrate a clinical benefit46 
shall be understood as a requirement to demonstrate the performance of the 
device.  
 
In addition, since the common specifications (CS) for the products without an 
intended medical purpose may have requirements related to the clinical 
evaluation regarding safety47 these requirements must be taken into 
consideration when demonstrating equivalence and concluding whether there 
would be no clinically significant difference in the safety48. 
 
There shall be no significant difference in the safety and performance between 
the product and the presumed analogous medical device.  
5. Use of data from similar devices 
The term ‘similar devices’ may be understood as devices belonging to the same 
generic device group. The MDR defines this49 as 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. 
In cases where equivalence cannot be demonstrated under the MDR, the data from 
similar devices may be useful for a variety of other purposes, for example: 
1. Ensuring that the risk management system is comprehensive by identifying 
relevant hazards and clinical risks. 
2. Understanding the state of the art, the natural course of disease and 
alternative available treatment options. 
3. Helping to define the scope of the clinical evaluation, by identifying any design 
features in similar devices that pose special performance or safety concerns. 
4. Provide input for clinical investigation design or post-market clinical follow-up 
design, and the post-market surveillance system. 
5. Identification of relevant and specified clinical outcome parameters for the 
intended clinical benefits, based on the published clinical data pertaining to the 
similar device(s). 
6. To define minimum requirements for a quantified clinical benefit that is 
considered clinically relevant, and/or to identify acceptable occurrence rates of 
risks and adverse events. 
                                                             
45 MDR, Annex XIV Part A (3). 
46 MDR, Article 61 and Annexes XIV and XV. 
47 MDR, Article 1 (2). 
48 MDR, Annex XIV Part A (3). 
49 MDR, Article 2 (7).  
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 6. Clinical data identification 
A clinical evaluation of the device under assessment shall be made according to the 
MDR50. All the clinical data, both favourable and unfavourable shall be identified. This 
applies to clinical data from both the device in question and the device for which 
equivalence can be demonstrated. If the data meet the definition of clinical data as 
defined in the MDR51, the data shall then progress to data appraisal and analysis in 
order to evaluate whether the clinical data are providing sufficient clinical evidence for 
the purpose of confirmation of conformity with the relevant general safety and 
performance requirements (GSPR)52.  
For identifying, appraising and analysing available clinical data from the scientific 
literature to establish clinical evidence53, manufacturers will find facilitative guidance in 
sections 8-10 of MEDDEV 2.7/1 rev. 4.  
In the event that the data do not meet the MDR definition of clinical data these are not 
clinical data and cannot be subject to data appraisal, analysis and evaluation for the 
purpose of providing clinical evidence for the confirmation of conformity with the 
relevant GSPR.  
 
  
                                                             
50 MDR, Annex XIV Part A. 
51 MDR, Article 2 (48). 
52 MDR, Annex I. 
53 MDR, Article 2 (51).  
Page 16 of 20 
 Annex I – Equivalence table 
A table, such as the table below, may be used to clearly demonstrate equivalence and 
to identify the supporting data on a device by device basis. The items in the first column 
of the table are examples only and are to be considered as such. They must not be 
interpreted as an exhaustive list of specifications, properties, parameters and/or 
aspects for demonstrating equivalence to another device. 
The manufacturer should identify differences and place emphasis on the differences 
between the two devices rather than the similarities. Considerations shall include the 
potential additive effect of multiple small differences. For further considerations of 
equivalence, see sections 3 and 4 in this document.  
Scientific justifications shall be provided for the different characteristics when claiming 
no clinically significant difference in the safety and clinical performance of the device. 
Where more than one device is assessed for equivalence, the table should be 
completed separately for each presumed equivalent device. The documentation of the 
demonstration of equivalence shall be included in the clinical evaluation report. 
 Medical Device       
Medical Device Coordination Group Document   MDCG  2020-5  
 
  
Equivalence table 
for the comparison of a device with a presumed equivalent marketed device for the purpose of demonstrating equivalence 
1. Technical 
characteristics  
(add a separate row 
for each of the 
assessed 
characteristics)  Device 1  (under clinical evaluation)  
Description of characteristics and  
reference to specifying documents Device 2 (marketed device) 
Description of characteristics and  
reference to specifying documents  Identified differences or  
conclusion that there are no differences in the 
characteristic 
Device is of similar 
design   1.1 
Used under similar 
conditions of use 
   1.2 
Similar specifications 
and properties 
including 
physiochemical 
properties such as 
intensity of energy, 
tensile strength, 
viscosity, surface 
characteristics, 
wavelength and 
software algorithms    1.3 
Uses similar 
deployment methods 
where relevant   1.4 
Has similar principles 
of operation and   1.5  
Page 18 of 20 
 critical performance 
requirements 
Scientific justification why there would be no clinically significant difference in the safety and clinical performance of th e device, OR  
a description of the impact on safety and or clinical performance 
(use one row for each of the identified differences in characteristics, and add references to documentation as applicable) Clinically 
significant 
difference 
Yes / No  
1.1  
1.2  
1.3  
1.4  
1.5  
2. Biological 
characteristics   
(add a separate row 
for each of the 
assessed 
characteristics)  Device 1 
Description of characteristics and  
reference to specifying documents Device 2 (marketed device) 
Description of characteristics and  
reference to specifying documents  Identified differences or  
conclusion that there are no differences in the 
characteristic 
Uses the same 
materials or 
substances in contact 
with the same human 
tissues or body fluids     (The characteristic must be the same for the 
demonstration of equivalence) 
2.1 
Similar kind and 
duration of contact 
with the same human 
tissues or body fluids 
   2.2 
Similar release 
characteristics of 
substances including 
degradation products 
and leachables   2.3 
Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR  
a description of the impact on safety and or clinical performance 
(use one row for each of the identified differences in characteristics, and add references to documentation as applicable) Clinically  
significant 
difference 
Yes / No   
Page 19 of 20 
 2.1  
2.2  
2.3  
3. Clinical 
characteristics   
(add a separate row 
for each of the 
assessed 
characteristics)  Device 1 
Description of characteristics and  
reference to specifying documents Device 2 (marketed device) 
Description of characteristics and  
reference to specifying documents  Identified differences or  
conclusion that there are no differences in the 
characteristic 
Same clinical 
condition or purpose, 
including similar 
severity and stage of 
disease   3.1 
Same site in the body 
   (The characteristic must be the same for the 
demonstration of equivalence) 
3.2 
 
Similar population, 
including as regards 
age, anatomy and 
physiology    3.3 
Same kind of user 
   (The characteristic must be the same for the 
demonstration of equivalence) 
3.4 
Similar relevant 
critical performance in 
view of the expected 
clinical effect for a 
specific intended 
purpose 
   3.5 
Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR 
a description of the impact on safety and or clinical performance 
(use one row for each of the identified differences in characteristics, and add references to documentation as applicable) Clinically 
significant 
difference 
Yes / No   
Page 20 of 20 
 3.1  
3.2  
3.3  
3.4  
3.5  
Summary  
In the circumstance that more than one non-significant difference is identified, provide a justification whether the sum of differences may affect the safety and clinical 
performance of the device.