REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council on single-use devices and their reprocessing
Date: 2024-11-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, health legislation, marketing standard, medical device, non-durable goods, product safety, risk management, safety standard, technical specification, used goods

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 29.11.2024  COM(2024) 560 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council on single-use devices and their reprocessing  
 
 
Table of Contents 

1 

2 

3 

4 

Executive summary ......................................................................................................................... 2 

Introduction ..................................................................................................................................... 3 

Study on the implementation of Article 17 of the MDR ................................................................. 3 

Legal framework on reprocessing of SUDs .................................................................................... 4 

4.1 

4.2 

Article 17 of the MDR ............................................................................................................. 4 

National laws on reprocessing of SUDs .................................................................................. 6 

5  Operation of provisions on reprocessing of SUDs .......................................................................... 7 

5.1 

Notified Bodies (NBs) ............................................................................................................. 7 

5.2  Manufacturers (MFs) / external reprocessors .......................................................................... 8 

5.3 

5.4 

5.5 

Health Institutions (HIs) .......................................................................................................... 8 

Challenges and obstacles ......................................................................................................... 9 

Opportunities ........................................................................................................................... 9 

6  Outcome of evidence gathering ..................................................................................................... 10 

6.1 

6.2 

Stakeholders’ views ............................................................................................................... 10 

Study outcome ....................................................................................................................... 11 

7 

Stocktaking .................................................................................................................................... 11 

8  Conclusions ................................................................................................................................... 12 

1 

 
 
 
 
1  EXECUTIVE SUMMARY 

Regulation (EU) 2017/745 on medical devices (MDR), which is applicable since 26 May 2021, aims 
to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a 
high level of protection of health for patients and users. For the first time at EU level, the MDR sets 
out specific rules on single-use devices (SUDs) and their reprocessing. 

This report presents data and information on the implementation of Article 17 of the MDR on single-
use devices and their reprocessing. Data and information refer to the period from December 2022 to 
December 2023 and have been collected, by a dedicated study, from relevant groups of stakeholders in 
30 countries (27 EU Member States, Iceland, Liechtenstein and Norway). 

Reprocessing and further use of SUDs may only take place where permitted by national law and only 
in accordance with the provisions set out in Article 17 of the MDR. Currently, only 10 countries allow 
reprocessing  of  SUDs  while  the  remaining  20  do  not  allow  it.  Most  of  the  countries  permitting 
reprocessing established further restrictions or prohibitions at national level. The non-harmonised and 
fragmented regulatory framework is a challenge for the affected stakeholders. 

Only 6 out of 38 surveyed notified bodies certify reprocessed SUDs or the reprocessing of SUDs. No 
certificates  have  been  issued  so  far.  A  very  low  number  of  manufacturers  reprocessing  SUDs  have 
been identified (less than 10) and only two are active and operate in the EU. The main reason for the 
limited interest shown by manufacturers seems to be linked to the difficulty in finding a notified body 
that  can  certify  reprocessed  devices.  10  out  of  19  surveyed  health  institutions  are  not  interested  in 
reprocessing SUDs due to the lack of competences and resources. 

The  main  perceived  opportunities  of  reprocessing  of  SUDs  by  all  stakeholder  groups  are 
environmental benefits, possible cost savings and a possible solution for shortages of devices.  

The  main  challenges  and  obstacles  for  the  implementation  of  Article  17  of  the  MDR  are  the 
fragmented regulatory landscape for reprocessing of SUDs, the lack of resources and a scarce interest 
in  reprocessing  of  SUDs  from  the  notified  bodies.  Possible  health  risks,  liability  issues  and  lack  of 
evidence  on  the  reprocessing  are  also  considered  obstacles  by  competent  authorities  on  medical 
devices and health institutions. 

The  market  of  reprocessing  SUDs  is  very  limited  and  not  attractive  for  notified  bodies  that  are 
currently mainly focused on the transition of certificates from the former directives on medical devices 
to the MDR. 

The Commission will further assess the operation of the provisions on reprocessing also in the light of 
new data. If appropriate, the Commission will consider possible options to address any shortcomings. 

2 

 
 
2  INTRODUCTION 

Regulation (EU) 2017/7451 on medical devices (MDR), which is applicable since 26 May 2021, aims 
to ensure the smooth functioning of the internal market as regards medical devices, and high standards 
of quality and safety for medical devices, thus ensuring a high level of protection of health and safety 
of patients, users and other persons, while fostering innovation and improving the competitiveness of 
the medical device sector. 

Under the MDR, medical devices are divided into four risk classes. Depending on the risk class of the 
product, a different conformity assessment procedure is required before the product can be placed on 
the  EU  market.  In  case  of  medium  or  high-risk  classes,  notified  bodies  (NBs)  are  involved  in  the 
conformity assessment process.  

For the first time at EU level, the MDR in its Article 17 sets out specific rules on single-use devices 
(SUDs) and their reprocessing. The MDR defines ‘Single-use devices’ as devices ‘intended to be used 
on one individual during a single procedure2 and ‘Reprocessing’ as ‘a process carried out on a used 
device  in  order  to  allow  its  safe  reuse  including  cleaning,  disinfection,  sterilisation  and  related 
procedures, as well as testing and restoring the technical and functional safety of the used device’3 .  

Reprocessing and further use of SUDs may only take place where permitted by national law and only 
in accordance with the requirements laid down in Article 17 of the MDR.   

In accordance with Article 17(10) of the MDR, the present report assesses the practical functioning of 
the provisions on SUDs and their reprocessing and will be submitted to the European Parliament and 
to the Council4. 

3  STUDY ON THE IMPLEMENTATION OF ARTICLE 17 OF THE MDR 

In  December  2022,  the  Commission  contracted  a  “Study  on  the  implementation  of  Article  17  of 
Regulation (EU) 2017/745 on medical devices on the EU market”5, hereinafter referred to as the study.  

The study provides data and information on how the provisions established in Article 17 of the MDR 
have been implemented by the 27 EU Member States, Iceland, Liechtenstein and Norway (hereinafter 
referred to as the study countries) and on how such provisions operate. Data and information gathered 
under the study refer to the period from December 2022 to December 2023. 

The  contractor  identified  four  relevant  stakeholder  groups:  all  competent  authorities  on  medical 
devices  (CAs),  all  notified  bodies  designed  under  the  MDR  (NBs),  a  sample  of  reprocessors 
considered  manufacturers  of  the  reprocessed  SUD  (MFs)  and  a  sample  of  health  institutions 
reprocessing SUDs (HIs). Data and information were collected through dedicated surveys from each 
stakeholder group. Surveys were followed up by interviews conducted on a sampling base. All CAs 
and all NBs replied to the survey, while data and information from MFs and HIs were collected from 
the sampled stakeholders. 

1 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/EEC - http://data.europa.eu/eli/reg/2017/745/2023-03-20. 
2 Article 2(8) MDR. 
3 Article 2(39) MDR. 
4  In  August  2010,  the  Commission  submitted  to  the  European  Parliament  and  the  Council  the  “Report  on  the 
issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 
93/42/EEC”, which provided the factual basis for the regulation of reprocessing of SUDs in Article 17 MDR - 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52010DC0443. 
5  European  Commission,  European  Health  and  Digital  Executive  Agency,  Windisch,  F.,  Zimmermann,  N., 
Knoll, V. et al., Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on 
the  EU  market 
2024, 
https://data.europa.eu/doi/10.2925/210943. 

report,  Publications  Office 

the  European  Union, 

–  Final 

of 

3 

 
 
 
The study is the main source of data and information used  for the preparation  of the present report, 
complemented  by  information  provided  by  Member  States  to  the  Commission6  before  May  2024. 
Information  from  the  study  is  repeated  in  this  report  where  useful  to  clearly  describe  a  topic  or  a 
recommendation or a proposal for amendment of the MDR and is clearly referenced.  

A dedicated dashboard7 offers the possibility to get more comprehensive and interactive access to the 
study results. 

4  LEGAL FRAMEWORK ON REPROCESSING OF SUDS 

4.1  Article 17 of the MDR 

Reprocessing and further use of SUDs may only take place only where permitted by national law and 
only in accordance with requirements set out in Article 17 to the MDR.  

Any  natural  or  legal  person  who  reprocesses  a  SUD  to  make  it  suitable  for  further  use  within  the 
Union  is  considered  to  be  the  manufacturer  of  the  reprocessed  device  and  assumes  the  obligations 
incumbent  on  manufacturers  laid  down  in  the  MDR.  Such  obligations  include  those  relating  to  the 
traceability of the reprocessed device.  

As regards SUDs that are reprocessed and used within a health institution, Member States may decide 
not to apply all the rules relating to manufacturers' obligations laid down in the MDR, provided that 
they ensure that: 

(a)  the  safety  and  performance  of  the  reprocessed  device  is  equivalent  to  that  of  the  original 

device and it complies with certain requirements of Article 5(5)8 of the MDR ;  

(b)  the reprocessing is performed in accordance with the  common specifications (CS)9 detailing 
the requirements concerning risk management, validation of procedures for the entire process 
including  cleaning  steps,  product  release  and  performance  testing,  quality  management 
system, reporting of incidents involving devices that have been reprocessed, and traceability 
of reprocessed devices.  

Member States must encourage, and may require, health institutions to provide information to patients 
on  the  use  of  reprocessed  devices  within  the  health  institution  and,  where  appropriate,  any  other 
relevant information on the reprocessed devices that patients are treated with.  

Member States may choose to apply the CS also as regards SUDs that are reprocessed by an external 
reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is 
returned to that health institution and the external reprocessor complies with the requirements of the 
CS.  

Compliance  with  the  CS  must  be  certified  by  a  NB,  both  for  health  institutions  and  external 
reprocessors. 

Member States that permit reprocessing of SUDs may maintain or introduce national provisions that 
are  stricter  than  those  laid  down  in  the  MDR  and  which  restrict  or  prohibit,  within  their  territory, 
certain operational aspects of the reprocessing.  

The full text of Article 17 of the MDR states the following:  

6 Among others, notifications of Member States on how Article 17 MDR has been implemented at national level. 
7https://app.powerbi.com/view?r=eyJrIjoiODQxYjQ4ZDItZTUwYi00ZjkxLTk4YzctYWQ0MzZmMWRkNzhjIi
widCI6ImIyNGM4YjA2LTUyMmMtNDZmZS05MDgwLTcwOTI2ZjhkZGRiMSIsImMiOjh9. 
8  Article  5(5)  MDR  sets  out  conditions  to  be  met,  such  as,  the  device  cannot  be  transferred  to  another  legal 
entity,  the  device  use  occurs  under  appropriate  quality  management  system,  the  health  institutions  draw  up 
appropriate technical documentation and review experience gained from the use of the device. 
9  Commission  Implementing  Regulation  (EU)  2020/1207  of  19  August  2020  laying  down  rules  for  the 
application  of  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  as  regards  common 
specifications 
- 
the 
http://data.europa.eu/eli/reg_impl/2020/1207/oj. 

(OJ  L  273,  20.8.2020,  p.  3) 

single-use  devices 

reprocessing  of 

for 

4 

 
 
 
“1.  Reprocessing  and  further  use  of  single-use  devices  may  only  take  place  where  permitted  by 
national law and only in accordance with this Article. 

2. Any natural or legal person who reprocesses a single-use device to make it suitable for further use 
within  the  Union  shall  be  considered  to  be  the  manufacturer  of  the  reprocessed  device  and  shall 
assume  the  obligations  incumbent  on  manufacturers  laid  down  in  this  Regulation,  which  include 
obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this 
Regulation.  The  reprocessor  of  the  device  shall  be  considered  to  be  a  producer  for  the  purpose  of 
Article 3(1) of Directive 85/374/EEC. 

3.  By  way  of  derogation  from  paragraph  2,  as  regards  single-use  devices  that  are  reprocessed  and 
used  within  a  health  institution,  Member  States  may  decide  not  to  apply  all  of  the  rules  relating  to 
manufacturers' obligations laid down in this Regulation provided that they ensure that: 

(a)  the  safety  and  performance  of  the  reprocessed  device  is  equivalent  to  that  of  the  original 
device  and  the  requirements  in  points  (a),  (b),  (d),  (e),  (f),  (g)  and  (h)  of  Article  5(5)  are 
complied with; 

(b)  the reprocessing is performed in accordance with CS detailing the requirements concerning: 
− 

risk management, including the analysis of the construction and material, related properties 
of  the  device  (reverse  engineering)  and  procedures  to  detect  changes  in  the  design  of  the 
original device as well as of its planned application after reprocessing, 
the validation of procedures for the entire process, including cleaning steps, 
the product release and performance testing, 
the quality management system, 
the reporting of incidents involving devices that have been reprocessed, and 
the traceability of reprocessed devices. 

− 
− 
− 
− 
− 

Member States shall encourage, and may require, health institutions to provide information to patients 
on  the  use  of  reprocessed  devices  within  the  health  institution  and,  where  appropriate,  any  other 
relevant information on the reprocessed devices that patients are treated with. 

Member  States  shall  notify  the  Commission  and the other Member  States  of  the  national  provisions 
introduced pursuant to this paragraph and the grounds for introducing them.  The Commission shall 
keep the information publicly available. 

4.  Member  States  may  choose  to  apply  the  provisions  referred  to  in  paragraph  3  also  as  regards 
single-use  devices  that  are  reprocessed  by  an  external  reprocessor  at  the  request  of  a  health 
institution, provided that the reprocessed device in its entirety is returned to that health institution and 
the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 
3. 

5. The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point 
(b) of paragraph 3 by 26 May 2021. Those CS shall be consistent with the latest scientific evidence 
and shall address the application of the general requirements on safety and performance laid down in 
in this Regulation. In the event that those CS are not adopted by 26 May 2021 reprocessing shall be 
performed in accordance with any relevant harmonised standards and national provisions that cover 
the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with 
any relevant harmonised standards and national provisions, shall be certified by a notified body. 

6. Only single-use devices that have been placed on the market in accordance with this Regulation, or 
prior to 26 May 2021 in accordance with Directive 93/42/EEC, may be reprocessed. 

7.  Only  reprocessing  of  single-use  devices  that  is  considered  safe  according  to  the  latest  scientific 
evidence may be carried out. 

8.  The  name  and  address  of  the  legal  or  natural  person  referred  to  in  paragraph  2  and  the  other 
relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where 
applicable, in the instructions for use of the reprocessed device. 

5 

 
 
The name and address of the manufacturer of the original single-use device shall no longer appear on 
the label, but shall be mentioned in the instructions for use of the reprocessed device. 

9. A Member State that permits reprocessing of single-use devices may maintain or introduce national 
provisions  that  are  stricter  than  those  laid  down  in  this  Regulation  and  which  restrict  or  prohibit, 
within its territory, the following: 

(a)  the  reprocessing  of  single-use  devices  and  the  transfer  of  single-use  devices  to  another 

Member State or to a third country with a view to their reprocessing; 
(b)  the making available or further use of reprocessed single-use devices. 

Member States shall notify the Commission and the other Member States of those national provisions. 
The Commission shall make such information publicly available. 

10.  The  Commission  shall  by  27  May  2024  draw  up  a  report  on  the  operation  of  this  Article  and 
submit it to the European Parliament and to the Council. On the basis of that report, the Commission 
shall, if appropriate, make proposals for amendments to this Regulation.” 

4.2  National laws on reprocessing of SUDs 

Member States may permit the reprocessing of SUDs in their territories. There is no deadline for the 
Member  States  to  take  such  a  decision.  Without  that  permission  under  national  legislation,  the 
reprocessing  of  SUDs  is  not  allowed.  Based  on  the  notifications  and  the  information  received,  the 
current state-of-play is as follows: 

•  10 countries (Belgium, Croatia, Germany, Iceland, Ireland, the Netherlands, Poland, Portugal, 

Spain, Sweden) have adopted national rules allowing reprocessing of SUDs; 

•  20  countries  (Austria,  Bulgaria,  Cyprus,  the  Czech  Republic,  Denmark,  Estonia,  Finland, 
France,  Greece,  Hungary,  Italy,  Latvia,  Liechtenstein,  Lithuania,  Luxembourg,  Malta, 
Norway,  Romania,  Slovakia,  Slovenia)  have  not  (yet)  adopted  national  rules  allowing 
reprocessing of SUDs.  

Pursuant to Article 17(3) MDR, a Member State that permits the reprocessing in its territory can also 
allow,  under  certain  conditions,  health  institution  to  reprocess  SUDs  in  accordance  with  the  CS  by 
way of derogating from the need to assume the obligations incumbent on manufacturers in accordance 
with  Article  17(2).  In  addition,  such  derogations  can  be  extended  to  external  reprocessors  that 
reprocess SUDs at the request of a health institution. An overview of the state of play in the concerned 
study countries is included in the following Table 1. 

MF obligations 
Country decided to 
apply Article 17(2) 
MDR 

Common 
specifications 
Country decided to 
apply Article 17(3) 
MDR 

Outsourcing 
Country decided to 
apply Article 17(4) 
MDR 

COUNTRY 
Belgium 
Croatia 
Germany 
Iceland 
Ireland 
The Netherlands 
Poland 
Portugal 
Spain 
Sweden 
Table 1: options, restrictions, and prohibitions according to Article 17 MDR. 

yes 
no 
yes 
yes 
yes 
yes 
yes 
yes 
yes 
no 

yes 
yes 
yes 
yes 
no 
no 
no 
yes 
yes 
yes 

yes 
yes 
yes 
yes 
no 
no 
no 
yes 
yes 
yes 

Patient 
information 
Country 
encourages/requires 
health institutions to 
provide information 
to patients 
yes 
yes 
no 
no 
no 
no 
no 
yes 
yes 
no 

Restrictions and 
prohibitions 
Country imposed 
restrictions and 
prohibitions 
according to Article 
17(9) MDR 
yes 
yes 
yes 
no 
no 
yes 
yes 
yes 
yes 
yes 

Restriction and prohibitions imposed by seven of the countries listed in Table 1 include, for example: 

6 

 
 
 
 
•  bans  for  the  reprocessing  of  certain  devices  (e.g.,  SUDs  with  non-removable  batteries  and/or 

where data cannot be cleared; SUDs emitting ionising radiation; implantable devices); 
limitations to EU Member States for the outsourcing of reprocessing; 

• 
•  prohibition  to  reprocess  SUDs  that  have  come  in  contact  with  certain  tissues  (e.g.,  brain; 
backbone;  retina;  optic  nerve;  spinal  nerve  node;  Gasser's  ganglion;  pituitary  gland;  hard  dura 
mater)  or  have  been  used  for  procedures  on  patients  affected  by  Creutzfeldt-Jakob  disease  or  a 
variant of it; and, 

•  prohibition to transfer SUDs to any other country for reprocessing. 

In accordance with Article 17(3) and (9) MDR, the Commission makes the information about national 
rules concerning the reprocessing of SUDs publicly available on its website10.  

The  possibility  for  Member  States  to  permit  or  not  to  permit  reprocessing  of  SUDs,  to  allow 
derogations for ‘in house’ reprocessing and/or to set further restrictions on the reprocessing of SUDs 
has led to a fragmented implementation of the provisions on reprocessing of SUDs. In fact, two-thirds 
of  the  study  countries  do  not  allow  reprocessing  of  SUDs.  Each  country  that  decided  to  permit 
reprocessing  of  SUDs  made  use  of  the  possibility  to  provide  for  derogations  and/or  prohibitions  or 
restrictions at national level in a unique way. 

Additional  information  on  national  legislation  on  reprocessing,  derogations,  prohibitions/restrictions 
and notifications is available in Section 3.2 of the study. 

5  OPERATION OF PROVISIONS ON REPROCESSING OF SUDS 

The non-harmonised and fragmented regulatory framework is a challenge for stakeholders interested 
in reprocessing SUDs. 

5.1  Notified Bodies (NBs) 

NBs  designated  under  the  MDR  and  listed  in  the  Single  Market  Compliance  Space11  have  a 
fundamental  role  in  the  reprocessing  of  SUDs.  NBs  must  be  involved  in  the  conformity  assessment 
procedures of devices that are reprocessed SUDs by MFs in accordance with Article 17(2) of the MDR 
(hereinafter referred to as reprocessed SUDs) and must certify the compliance with the CS for HIs that 
reprocess and reuse SUDs in accordance with Article 17(3) (hereinafter referred to as reprocessing of 
SUDs). NBs must certify the compliance with the CS also for external reprocessors that, at a request 
of HIs, reprocess SUDs in accordance with Article 17(4). 

Only 6 out of 38 surveyed NBs certify reprocessed SUDs and 5 of out of those 6 certify reprocessing 
of SUDs. The remaining 32 NBs do not offer those services. At the time of the completion of the study 
(December 2023): 

•  no certificates were issued either for reprocessed SUDs or for the reprocessing of SUDs; 
• 

applications  were  lodged  with  only  two  NBs:  two  clients  (manufacturers)  submitted 
applications  for  conformity  assessment  procedures  (CE  marking)  and  one  client  (health 
institution/external reprocessor) submitted an application for certification of compliance with 
the CS. 

The main issues identified by NBs that do not certify reprocessed SUDs or reprocessing of SUDs are 
related to the designation codes, to the fact that reprocessing is not allowed in the country where the 
NB is based and  to the fact that there is a very limited number of clients interested  in reprocessing. 
Other challenges and obstacles are summarised below in point 5.4. 

10 Reprocessing of medical devices - European Commission (europa.eu) 
11 
list?filter=bodyTypeId:3,legislationId:34. 

https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-

7 

 
 
 
Some  unclarity  was  reported  regarding  the  identification  of  the  relevant  designation  process12  and 
designation codes13 for NBs which are involved in the conformity assessment of reprocessing SUDs. 
NBs  that  certify  reprocessed  SUDs  indicated  that  the  designation  code  MDT  2013  (devices  which 
have  undergone  reprocessing)  plus  additional  product-specific  MDR  codes  are  relevant.  Most  NBs 
that  certify  the  reprocessing  of  SUDs  indicated  that  the  designation  codes  are  the  same  as  those 
necessary for the certification of reprocessed SUDs. Some of those NBs indicated that the designation 
codes  are  not  clear,  and  that  no  specific  MDT  code  is  available  for  reprocessed  devices.  One  NB 
declared that the necessary designation codes should be defined by national measures and that at the 
time of the study such measures have not been adopted yet.  

Additional information on NBs is available in Section 3.3.1 of the study. 

5.2  Manufacturers (MFs) / external reprocessors 

A very low number of MFs of reprocessed SUDs were identified (less than 10) and only two are active 
and operate in the EU. Both are small and medium-sized enterprises. While only one of the companies 
acts as a manufacturer of reprocessed SUDs (CE-marked devices) and offers reprocessing as a service 
complying with the CS, the other offers reprocessing as a service (CS) only. 

About  half  of  the  reprocessed  SUDs  are  cardiovascular  devices,  but  arthroscopic,  orthopaedic, 
laparoscopic and SUDs for general surgery are also reprocessed. All risk classes, from class I to class 
III, are represented. 

The main reason for the limited interest shown by MFs in reprocessing SUDs seems to be linked to the 
difficulty in finding a NB, especially for the certification of the reprocessing of SUDs in accordance 
with the CS. 

Information on MFs is available in Section 3.3.2 of the study. 

5.3  Health Institutions (HIs) 

19 replies from HIs were considered in the framework of the study. All HIs are based in countries that 
allow reprocessing. Unlike for the other stakeholders that were contacted directly, the survey for HIs 
was  disseminated  via  various  channels  (e.g.,  members  of  the  European  Hospital  and  Healthcare 
Federation, members of World Federation for Hospital Sterilisation Sciences) due to the difficulty in 
identifying all the reference persons for each institution. 

9 out of 19 HIs indicated that they reprocess or plan to reprocess and/or reuse SUDs.  Three of them 
are also considering the outsourcing of the reprocessing to an external reprocessor. At the time of the 
survey, none of them held a certificate and none of them had lodged an application with a NB for the 
certification. 

Eight HIs are aware of national rules on reprocessing SUDs and three of them are aware about national 
restrictions and prohibitions. One HI that is currently reprocessing SUDs indicated to not be aware of 
any restrictions. 

Four HIs indicated that they reprocess/plan to reprocess SUDs and/or to purchase and use reprocessed 
SUDs. Three of those HIs indicated that the decision was made for economic reasons and to reduce 
shortages issues in special circumstances, such as the COVID-19 pandemic.  

12  MDCG  2019-6  “Questions  and  answers:  Requirements  relating  to notified  bodies”,  in Section  V.1,  clarifies 
that  activities  described  under  Article  17  to  the  MDR  are  not  covered  by  Chapter  IV  and  Annex  VII  - 
https://health.ec.europa.eu/document/download/9c9c532f-013a-477c-9378-
0a9e714e5549_en?filename=md_mdcg_qa_requirements_notified_bodies_en.pdf. 
13  Commission  Implementing  Regulation  (EU)  2017/2185  of  23  November  2017  on  the  list  of  codes  and 
corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in 
the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and 
in  vitro  diagnostic  medical  devices  under  Regulation  (EU)  2017/746  of  the  European  Parliament  and  of  the 
Council - http://data.europa.eu/eli/reg_impl/2017/2185/oj. 

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10 out of 19 HIs are not interested in reprocessing. The main reasons for this decision are the lack of 
competences and resources on SUDs, possible concerns about patient safety and the lack of interest on 
the reprocessing of SUDs. 

Information on HIs is available in Section 3.3.2 of the study. 

5.4  Challenges and obstacles 

Despite  the  availability  of  five  NBs  offering  their  services  to  reprocessors,  finding  a  NB  for  the 
certification of reprocessing of SUDs in accordance with the CS remains a challenge. NBs highlighted 
that their available resources are still working on the transfer of certificates issued under the former 
directives  on  medical  devices  and  that  this  determines  a  lack  of  capacity  for  the  certification  of 
reprocessing. In general, reprocessing SUDs requires specific expertise and resources to comply with 
the applicable requirements and decisions on investing such resources in reprocessing are negatively 
affected by the uncertainties surrounding applicable requirements (e.g., criteria for and availability of 
NBs, suitability of SUDs to be reprocessed), despite some MFs see possible advantages.  

Another challenge is linked to the perception within CAs, NBs and HIs of reprocessing of SUDs as a 
source of possible health risks for the patients. In addition, specific characteristics of SUDs, such as 
the geometry or the materials, bring in concerns on the suitability of the device for the reprocessing. 

Changes  to  the  SUD  made  by  its  manufacturer  (e.g.,  geometry,  components,  materials)  may  not  be 
easily detectable by reprocessors and could undermine the validation of the reprocessing processes. 

Alongside these empirical considerations, CAs, NBs and HIs emphasised the need for more evidence 
and comparative data to validate the suitability of reprocessing SUDs. Ethical considerations were also 
raised as regards the manufacturers practice to label devices as single-use instead of as reusable. 

CAs  and  HIs  finally  noted  that  ad  hoc  surveillance  activities,  monitoring  and  communication  of 
incidents should be put in place for the reprocessing of SUDs and that there are concerns on liability 
issues related to reprocessed SUDs. 

Table 2 below summarises the most common challenges and obstacles identified by each stakeholder 
group with the number of stakeholders who identified each challenge. 

PERCEIVED CHALLENGES 

Finding a NB for the certification 
Lack of capacity of the certification 
Possible health risks 
Complexity of reprocessing SUDs 
Differences  in  the  suitability  of  devices  for 
reprocessing 
Issues of liability 
Lack of evidence 
Practice of manufacturers 
Table 2: General challenges for reprocessing SUDs as indicated by the stakeholders. 

- 
- 
CA (30) 
- 
CA (17) 

CA (19) 
CA (16) 
CA (8) 

NB (24) 
NB (18) 
NB (8) 

INDICATED BY THE FOLLOWING 
STAKEHOLDER GROUP 
(number of stakeholders that perceived the challenge) 
HI (4) 
- 
HI (6) 
- 
HI (2) 

- 
NB (9) 
NB (25) 
NB (28) 
NB (15) 

MF (1) 
- 
- 
MF (2) 
- 

- 
- 
- 

HI (5) 
HI (3) 
HI (2) 

Information on challenges is available in Section 3.4.1 of the study. 

5.5  Opportunities 

The  main  perceived  opportunities  of  reprocessing  of  SUDs  by  all  stakeholder  groups  are 
environmental  benefits,  possible  cost  savings  and  a  possible  solution  for  shortages  of  devices.  MFs 
and  HIs  consider  reprocessing  of  SUDs  beneficial  also  for  increasing  competition  and  some  HIs 
highlighted  a  possible  enhancement,  in  some  specific  instances,  for  the  quality  of  care  (e.g., 

9 

 
 
 
 
reprocessed  electrophysiology  catheters  could  have  reduced  stiffness,  enabling  cardiologists  to 
perform treatments more effectively in patients with challenging anatomies). 

Table 3 below presents the most common opportunities identified by each stakeholder group with the 
number of stakeholders who identified each opportunity. 

PERCEIVED OPPORTUNITIES 

Environmental benefit 
Cost savings 
Solution for shortages 
Increase of competition 
Improved quality of care 
Table 3: opportunities for reprocessing SUDs indicated by the stakeholders. 

INDICATED BY THE FOLLOWING 
STAKEHOLDER GROUP 
(number of stakeholders that perceived the opportunity) 
HI (8) 
CA (21) 
HI (6) 
CA (25) 
HI (6) 
CA (21) 
HI (5) 
- 
HI (1) 
- 

NB (21) 
NB (25) 
NB (14) 
- 
- 

MF (2) 
MF (1) 
MF (1) 
MF (1) 
- 

Information on opportunities is available in Section 3.4.2 of the study. 

6  OUTCOME OF EVIDENCE GATHERING 

6.1  Stakeholders’ views 

Stakeholders recommended to take some actions to improve the implementation of Article 17  of the 
MDR. Among others, amending the MDR to strengthen regulatory requirements (e.g., require suitable 
qualifications for operators conducting the reprocessing; adding preconditions for the reprocessing in 
Article 5214 of the MDR to ensure that reprocessors have the technical ability to reprocess SUDs) was 
mentioned. In addition, drafting guidelines, including a step-by-step manual for the implementation of 
the MDR and the CS has been considered as a  useful tool to ease the implementation. Furthermore, 
HIs recommended strengthening the support from regulatory authorities at national or EU level, which 
might help to address the lack of NBs willingness to certify reprocessing of SUDs according to the CS. 
Stakeholders  recommended  that  ad  hoc  task  forces  or  working  groups  at  EU  level  could  be  also 
established.  

In Stakeholders’ opinion, a clear tracking system and an improved surveillance system could be useful 
as well as an increased availability of scientific studies on the safety of SUDs. In addition, improving 
staff  education  and  strengthening  risk  management  for  reprocessed  SUDs  were  also  considered  as 
relevant. 

Some  stakeholders  would  welcome  EU-wide  lists  that  identify  SUDs  suitable  to  be  reprocessed 
(positive  lists)  or  SUDs  not  suitable  to  be  reprocessed  (negative  lists).  While  overall  CAs  and  NBs 
were in favour of both positive or negative EU-wide lists of SUDs, MFs opposed the idea, suggesting 
that  a  single  list  could  not  be  fully  justified  from  a  scientific  perspective  and  would  be  difficult  to 
establish, in the light of the variety of SUDs which might be reprocessed. 

One industry association reported that, as the MDR’s implementation currently stands, for economic 
reasons there is a strong incentive for MFs to label products as ‘single-use’ rather than reusable. This 
actively hinders the aim of achieving a circular economy in the medical devices sector. According to 
this association, there are variations in the extent to which products are reusable in practice, and this 
should be determined on a product-by-product basis by NBs as an independent third party. 

Table 4 below presents the main recommended actions identified by each stakeholder group with the 
number of stakeholders who recommended each action. 

14 Article 52 of the MDR on conformity assessment procedures sets out requirements for the assessment of  the 
conformity of the device to the MDR in view of its placing on the market. 

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RECOMMENDED ACTIONS 

INDICATED BY THE FOLLOWING 
STAKEHOLDER GROUP 
(number of stakeholders that recommended the action) 
HI (5) 
CA (18) 
HI (5) 
CA (20) 

NB (22) 
NB (25) 

MF (2) 
- 

for 

Regulatory requirements 
Identification  of  suitable  products 
reprocessing 
Clear tracking system 
Improving staff education 
Risk management 
Extended producer responsibility 
Clarification on designation codes 
Amendments in the MDR 
Table 4: potential actions and recommendations indicated by the stakeholders. 

CA (20) 
CA (16) 
CA (17) 
CA (10) 
- 
CA (5) 

NB (19) 
NB (11) 
NB (15) 
NB (12) 
NB (14) 
NB (6) 

- 
MF (1) 
- 
- 
MF (1) 
MF (1) 

HI (2) 
HI (3) 
HI (4) 
HI (4) 
HI (2) 
HI (2) 

Information on recommended actions from the stakeholders is available in Section 3.5 of the study. 

6.2  Study outcome 

Taking  into  consideration  the  study  results,  the  study  contractor  provided  recommendations  for 
removing  the  existing  obstacles  in  the  implementation  of  Article  17  of  the  MDR.  Those 
recommendations take stock of information provided by all the surveyed stakeholders and have been 
clustered in the following five categories: 

•  General recommendations: promote  generation of evidence; support clarity and transparency 
of  national  provisions;  improve  communication  and  collaboration  among  Member  States; 
establish task forces/working groups involving stakeholders; 

•  EU  legal  framework  and  guidance  documents:  clarify  terms  and  concept  to  ensure  common 
understanding; develop guidance documents about the reprocessing of SUDs and establish a 
dedicated monitoring mechanism for the implementation of Article 17 of the MDR; 

•  Certification:  inform  MFs  about  NBs  designated  for  certifying  the  reprocessing  of  SUDs; 
clarify concepts and accountability of NBs for certification of compliance with the CS; clarify 
the requirements for the designation of NBs, including qualifications needs and related codes; 
•  Product-related recommendations: develop EU-wide lists on the suitability of different types 
of SUDs for reprocessing; use of EUDAMED; support improved risk management and market 
surveillance; and, 

•  Measures  at  national  level:  take  measures  to  support  the  implementation  of  reprocessing 

SUDs; implement targeted measures for HIs. 

More detailed information on recommended actions proposed by the contractor is available in Section 
5 of the study. 

7  STOCKTAKING 

The study identified  challenges and  obstacles for the implementation of Article 17 of the MDR  and 
provided recommendations for addressing them on the basis of key stakeholder positions. Considering 
that the current situation is fragmented and not harmonised across the EU, providing clarifications and 
guidance  on  how  to  implement  the  existing  provisions  on  reprocessing  of  SUDs  might  not  be 
sufficient. Alternative solutions may have to be explored. 

In particular, the MDR includes a specific definition of ‘reusable surgical instruments’15 and requires 
that the instructions for use of those reusable devices include information on the appropriate processes 

15 See Section 2.3 of Annex VIII to the MDR: ‘Reusable surgical instrument’ means an instrument intended for 
surgical  use  in  cutting,  drilling,  sawing,  scratching,  scraping,  clamping,  retracting,  clipping  or  similar 

11 

 
 
 
 
 
for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated 
method of re-sterilisation. In addition, instructions for use must provide information to identify when 
the  device  should  no  longer  be  reused  (e.g.,  signs  of  material  degradation,  maximum  number  of 
allowable reuses)16. 

Provisions  on  the  reuse  of  a  device  other  than  SUDs  are  established  in  the  MDR  and  harmonised. 
Contrary to Article 17(1) of the MDR that introduced some flexibility and allows Member States to 
prohibit reprocessing, there are no possibilities for Member States to prohibit or restrict the reuse of a 
device. Responsibilities of manufacturers, NBs and HIs are defined in the MDR for reusable devices. 
The manufacturers must provide information to allow the reuse, NBs are involved in the conformity 
assessment procedure depending on the class of the device and HIs have to follow the manufacturer’s 
instructions to reuse the device.  

Even if the MDR definition of the term ’reprocessing’17 refers to devices in general, in the MDR that 
term  is  used  only  for  SUDs.  Nevertheless,  the  processes  for  allowing  reuse  of  certain  devices 
explicitly referred to in the MDR are very similar to those for reprocessing and both share the same 
objective, namely allowing the reuse of a device. 

Exploring  the  possibility  to  bring  the  concept  of  reprocessing  of  SUDs  closer  to  that  of  reuse  of  a 
device appears promising and would remove most of the obstacles identified for the implementation of 
reprocessing addressing also the ethical considerations as regards manufacturers practice of labelling 
devices as single-use instead of as reusable. 

Considering  that  the  MDR  does  not  provide  requirements  for  the  manufacturers  when  deciding 
whether a device is ‘single-use’ or ‘reusable’, it would be beneficial to also explore the possibility of 
establishing criteria to be followed when deciding whether a device is single-use or reusable, provided 
that a specific assessment has been carried out in this respect. The aim of such approach would be to 
ensure that a reusable device would not be labelled as ‘single-use’. 

Natural  or  legal  persons  who  reprocess  SUDs  in  accordance  with  Article  17(2)  of  the  MDR  and 
comply with MDR obligations incumbent on manufacturers would be able to continue doing so and 
would be considered as manufacturers of fully refurbished devices18.  

Reprocessing  might  be  an  opportunity  for  reducing  environmental  impact  and  pursue  cost  savings; 
However, additional  evidence  needs  to be  generated and  collected to  explore  the  relevant  aspects  at 
stake. Further, scientific evidence is still necessary to support the feasibility of possible options for the 
way forward. 

8  CONCLUSIONS 

The implementation of Article 17 of the MDR is fragmented across the EU. Only 10 countries allow 
reprocessing  of  SUDs  and  only  six  NBs  offer  certification  services  for  reprocessed  SUDs  and/or 
reprocessing  of  SUDs  in  accordance  with  the  CS.  Most  of  the  countries  allowing  reprocessing  of 
SUDs have established national measures which limit reprocessing and/or subject it to conditions. 

Relevant  requirements  on  reprocessing,  especially  those  established  in  the  CS,  are  complex  to  be 
implemented. This leads to a potential knowledge gap and a need of developing new expertise.  

The market of reprocessed SUDs (MFs) and of reprocessing SUDs in accordance with the CS (HIs) is 
very  limited  and  not  attractive  for  NBs  that  are  currently  mainly  focused  on  the  transition  of 
certificates from the former directives on medical devices to the MDR. In addition, the existence of the 
relevant competences and expertise within the NBs to certify reprocessing is not confirmed, especially 
for reprocessing SUDs in accordance with the CS. 

procedures,  without a  connection  to  an  active device  and which  is  intended  by  the  manufacturer  to  be  reused 
after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. 
16 Point (n) of Section 23.4 of Annex I to the MDR. 
17 See definition of ‘reprocessing’ in paragraph (39) of Article 2 of the MDR. 
18 See definitions of ‘manufacturer’ and ‘fully refurbishing’ in paragraphs (30) and (31) of Article 2 of the MDR. 

12 

 
 
 
The Commission will further assess the operation of the provisions on reprocessing also in the light of 
new  data19,including  as  part  of  the  targeted  evaluation  of  the  MDR20.  If  appropriate,  based  on  the 
outcome  of  this  assessment,  the  Commission  will  consider  possible  options  to  address  any 
shortcomings.  

19 New data may concern changes in national legislation on reprocessing, number of applications and certificates 
for  reprocessed  SUDs  and  reprocessing  of  SUDs  in  accordance  with  the  CS,  NBs  offering  their  services  on 
reprocessing. 
20 See “EU rules on medical devices and in vitro diagnostics – targeted evaluation” on the Have your say portal 
of the Commission - EU rules on medical devices and in vitro diagnostics – targeted evaluation (europa.eu) 

13