COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the implementation of Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Date: 2022-11-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, application of EU law, coronavirus disease, cross-border cooperation, epidemic, organ transplantation, public health, quality standard, safety standard, substance of human origin

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.11.2022  SWD(2022) 376 final  COMMISSION STAFF WORKING DOCUMENT    Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the implementation of Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation {COM(2022) 671 final}  
 
 
1.  Designation and Obligations of the Competent Authorities  

1. Have there been any changes 
to the structures/designations of 
your competent authorities 
since the last survey (2014)? 

What are these changes? Please provide details 
(including to which competent authority they 
relate, if applicable) 

AT  No 
BE  No 
BG  Yes 

CY  No 
CZ  No 
DE  No 
DK  Yes 

EE  Yes 

EL  No 
ES  No 
FI  No 
FR  No 
HR  No 
HU  Yes 

IE  No 
IT  No 
LT  No 

Executive Agency for Transplantation is merged 
with Executive Agency for Medical Audit. Now we 
are part of a larger structure, dealing with donation, 
transplantation and control and audit of the medical 
establishments. The name of the Directorate, 
dealing with donation and transplantation activities 
is ‘Management and Control of the Transplantation 
and the Assisted Reproduction’. 

The CA has been Danish Patient Safety Authority 
since 2016 when this body was established. 
New Procurement, Handling and Transplantation of 
Cells, Tissues and Organs Act came in force in 
2015. 

The National transplantation agency was 
established and some tasks of it were delegated to 
Tartu University Hospital, such as organisation of 
traceability and biovigilance of the procurement, 
handling and transplantation of organs, 
maintenance of waiting lists and distribution and 
international exchange of organs to be transplanted. 

Estonia joined Scandiatransplant. 

HNBTS developed and manages the Hungarian 
National Transplant Follow up Registry for which 
all relevant health care service providers provide 
data according to the SOP of the HNBTS by law. 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LV  No 
NL  No 
PL  No 
PT  No 
SE  No 
SI  Yes 

SK  No  

2. Do you participate in EOEO 
activities? 

AT  Yes 
BE  No 
BG  Yes 
CY  No 
CZ  Yes 
DE  Yes 
DK  Yes 
EE  Yes 
EL  Yes 
ES  No 
FI  No 
FR  Yes 
HR  Yes 
HU  Yes 
IE  Yes 
IT  Yes 
LT  Yes 
LV  Yes 
NL  Yes 
PL  Yes 
PT  Yes 
SE  Yes 
SI  Yes 
SK  Yes 

The new law based on the Directive 53/2010 was 
adopted in 2015. 

Do you have an agreement with an EOEO 
(Article 21 of the Directive)? 
Yes 

Yes 

Yes 
Yes 
No 
Yes 
Yes 

Yes 
Yes 
Yes 
Yes 
No 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.1 Does your country exchange 
organs with other EU Member 
States? 

2.2 Does your country exchange organs with 
third countries? 

AT  Yes 
BE  Yes 
BG  Yes 
CY  Yes 
CZ  Yes 
DE  Yes  
DK  Yes 
EE  Yes 
EL  Yes 
ES  Yes 
FI  Yes 
FR  Yes 
HR  Yes 
HU  Yes 
IE  Yes 
IT  Yes 
LT  Yes 
LV  Yes 
NL  Yes 
PL  Yes 
PT  Yes 
SE  Yes 
SI  Yes 
SK  Yes 

Yes 
No 
No 
Yes 
No 
No 
Yes 
No 
No 
No 
No 
Yes 
No 
No 
Yes 
Yes 
Yes 
No 
No 
No 
Yes 
Yes 
No 
No 

Please specify in 
which cases you would 
be interested. 

Please specify the reasons 
why you see an interest in 
exchanging organs with 
other Member States in 
this case. 

2.3 Would your country be 
interested in increasing 
exchanges of organs with 
other Member States in any 
of the following cases? Please 
select all that apply. 
AT  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

BE  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

x 

x 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BG  ABO-incompatibility 

Less transplanted organs 
Children 
Other 

None 

CY  ABO-incompatibility 

Less transplanted organs 
Children 
Other 

None 

CZ  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

DE  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

DK  ABO-incompatibility 

Less transplanted organs 
Children 
Other 

None 

EE  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

x 
x 
x 
x 

x 

x 

x 

x 
x 

x 

x 

x 
x 

Lack of transplant 
program in our country 
- ABO incompatibility 
- Children  
- Urgent cases 

HLA hypersensitized 
patients 

To be given a chance for 
treatment of these specific 
patients that cannot be 
transplanted in Bulgaria in 
the particular moment. 

Increase the donor pool, 
especially for small 
countries like our country 
and increasing the 
possibility for ABO 
incompatible and 
hypersensitized patients to 
get transplanted 
Deficit of organs 

See above - an eventual 
increase of collaboration 
would probably and 
primarily be organised 
through Scandiatransplant. 

To increase the donor pool. 

DK is collaborating in 
all these areas through 
Scandiatransplant and 
has done this for more 
than 50 years. 
Exchange of organs 
with other countries 
happens, but only on 
rare occasions. 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EL  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

ES  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

x 

x 
x 

FI  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

FR  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

HR  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

HU  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

x 
x 
x 
x 

x 

x 

5 

The recipients belonging the 
selected categories have 
more difficulties in finding 
the adequate donor and 
organ, due to size, weight, 
hyperimmunized status, 
frailty of the organ itself, or 
any other reasons.  

The selection of these two 
categories is justified 
because exchanging organs 
theoretically increases the 
probability of receiving the 
necessary organ and getting 
out from the waiting list 
(expansion of the donor 
pool). 

Due to the lack of expertise 
of our expert team in 
transplant treatment for 
small children 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IE  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

IT  ABO-incompatibility 

Less transplanted organs 
Children 
Other 

None 

LT  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

LV  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

NL  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

PL  ABO-incompatibility 

Less transplanted organs 
Children 
Other 

None 

x 

x 

x 
x 
x 
x 

x 
x 

x 
x 
x 

x 

x 
x 

Ensure availability of 
organs is optimised for 
those on national waiting 
list for solid organ 
transplantation 
Accessing larger pools of 
genetically inhomogeneous 
patients/donors, where 
difficult-to-transplant 
patients may find proper 
compatibility in an easier 
way 

A supranational 
program for 
hyperimmunized 
patient for transplant 
from deceased donor. 

International kidney-
paired donation 
programs for transplant 
from living donors 

Children: needs related to 
the small number of 
paediatric deceased donors. 

Urgent cases: needs for 
directly life-saving 
treatment in the country 
with average donation rates. 

Paediatric and Urgent 
potential recipients. 

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PT  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

SE  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

SI  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

SK  ABO-incompatibility 

Less transplanted organs 
Children 
Other 
None 

x 

x 

x 

x 
x 
x 

Actually, we are interested 
in exchanging practices as it 
is. Namely, in Slovenia we 
have been already 
cooperating for more than 
20 years with Italy and 
Austria in the field of liver 
and kidney transplant 
program for small children 
because the number of cases 
is too low to keep the 
programs on the highest 
quality level. 
For kidney in the case of 
ABO incompatibility there 
are not enough pairs for 
exchange, and it is better 
chance to get suitable pairs. 
In our country is missing 
program for lung 
transplantation, now we 
have agreement with Czech 
Republic. We have not 
program for liver 
transplantation for children 
and sometimes is a problem 
with very small children for 
kidney transplantation. 

7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the  reporting  period,  was 

there  collaboration  between  your  competent 
3.  In 
authority/delegated body and authorities and stakeholders with adjacent areas of expertise 
in your Member State? 

If  yes:  To  what  extent  does  your  competent  authority/delegated  body  collaborate  with 
authorities and stakeholders with adjacent areas of expertise in your Member State? 

AT: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

BG: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

To a great 
extent 

To some 
extent 

Occasionally  Never 

x 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
National Health Insurance Fund 

x 

x 

x 

Not applicable 
(e.g., same CA) 
x 
x 

x 

x 

x 

Not applicable 
(e.g., same CA) 

x 

CZ:  

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 
x 

x 

8 

x 

x 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DE:  

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

x 

x 

x 

x 

Tissue and Cells: Ministry of Health – extend occasionally  
Medical Devices: Ministry of Health – extend occasionally  

Please specify which other competent authorities you collaborate with: 
Competent Authorities:  
- 
- 
Delegated Bodies:  
- 
Stakeholders:  
- 
Transfusionsmedizin und Immunhämatologie Frankfurt am Main gGmbH – To some extent  
- 

Blood: DRK-Blutspendedienst Baden-Württemberg – Hessen; Institut für 

Tissues and Cells: Individual Tissue banks – great extend 

Tissue and Cells: Paul Ehrlich Institute – to some extent  

DK: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 
x 
x 

x 

x 

x 

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EE: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
Occasionally collaboration with Data Protection Agency and Health Board has been required. 

x 

x 

x 

Not applicable 
(e.g., same CA) 
x 
x 

ES: 

To a great 
extent 

To some 
extent 
x 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
Competent authority on Assisted Human Reproduction, different from the competent authority 
on T&C (ONT) 

x 

x 

x 

x 

FR: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 
x 

x 

x 

x 

x 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HR: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

HU: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

IE: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

To a great 
extent 
x 
x 

x 

x 

x 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 
x 

x 

x 

x 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 

x 

x 

x 

x 

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IT: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 

x 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
Italian National Blood Centre, AIFA, Italian Health Ministry Office for Medical Devices, 
Italian Health 
Ministry Office for Prevention of Infectious Diseases, Italian National Institute of Health 

x 

x 

x 

LV: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
P. Stradin's University Hospital which is also delegated body for tasks regarding Article 5,6, 7 
of Directive 2012/25/EU 

x 

x 

x 

Not applicable 
(e.g., same CA) 
x 
x 

NL: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

x 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

12 

Not applicable 
(e.g., same CA) 
x 

x 

x 

x 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PL: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

PT: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

SE: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 

x 

x 

x 

x 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

To a great 
extent 

To some 
extent 
x 
x 

x 

x 

x 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

To a great 
extent 

To some 
extent 
x 
x 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
The Health and Social Care Inspectorate (IVO) and the Medical Products Agency 

x 

x 

x 

13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SI: 

To a great 
extent 

To some 
extent 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 

x 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 
Please specify which other competent authorities you collaborate with: 
NIJZ- National institute of public health to exchange and follow epidemiological data 

x 

x 

x 

SK: 

Blood 
Tissues and 
Cells 
Medicinal 
Products 
Medical 
Devices 
Others 

To a great 
extent 

x 

To some 
extent 
x 

Occasionally  Never 

Not applicable 
(e.g., same CA) 

x 

x 

x 

Which of the following topic(s) have been subject 
to such collaborative interactions? Please select all 
that apply. 

Please specify which other 
topics have been subject to 
collaborative interactions 

AT  Vigilance 

Traceability 
Donor protection 
Other 
None 

BE 
BG  Vigilance 

Traceability 
Donor protection 
Other 
None 

CY 

x 
x 
x 

x 

14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CZ  Vigilance 

Traceability 
Donor protection 
Other 
None 
DE  Vigilance 

Traceability 
Donor protection 
Other 
None 
DK  Vigilance 

Traceability 
Donor protection 
Other 
None 
EE  Vigilance 

Traceability 
Donor protection 
Other 
None 

EL 
ES  Vigilance 

Traceability 
Donor protection 
Other 
None 

FI 
FR  Vigilance 

Traceability 
Donor protection 
Other 
None 
HR  Vigilance 

Traceability 
Donor protection 
Other 
None 
HU  Vigilance 

Traceability 
Donor protection 
Other 
None 
IE  Vigilance 

Traceability 
Donor protection 

x 

x 
x 
x 

x 

x 
x 

x 

x 
x 
x 

x 
x 
x 

x 
x 

x 
x 

15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other 
None 
IT  Vigilance 

Traceability 
Donor protection 
Other 
None 

LT 
LV  Vigilance 

Traceability 
Donor protection 
Other 

None 
NL  Vigilance 

Traceability 
Donor protection 
Other 
None 
PL  Vigilance 

Traceability 
Donor protection 
Other 

None 
PT  Vigilance 

Traceability 
Donor protection 
Other 
None 
SE  Vigilance 

Traceability 
Donor protection 
Other 
None 
SI  Vigilance 

Traceability 
Donor protection 

x 

x 

x 

x 
x  Collaboration with P. Stradin's 
University Hospital which is 
also delegated body for tasks 
regarding Article 5,6, 7 of 
Directive 2012/25/EU 

x 
x 

x 

x  Tissue donation and banking. 
Maintaining national potential 
bone marrow donor registry. 
Centres accreditation. 
Construction of registries related 
to transplantation medicine. 

x  Cells and solid organ exchange. 

x 
x 
x 

x 
x 
x 

16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other 

None 
SK  Vigilance 

Traceability 
Donor protection 
Other 
None 

x  Besides vigilance, traceability 
and donor protection is very 
important promotion of donation 
based on fundamental ethical 
principles, altruism, and non-
profit approach. Furthermore, 
cooperation with other 
Competent authorities is also 
important to ensure transparency 
in the field of using parts of 
human body for the purposes of 
treatment or research. With 
NIJZ we are exchanging 
epidemiological data. 

x 
x 

3.1 Are there (other) areas in which 
your country would be interested to 
collaborate (more)? 

Please specify which area/authority you 
would consider relevant: 

AT  No 
BE  No 
BG  No 
CY  No 
CZ  No 
DE  No 
DK  No 
EE  No 
EL  Yes 
ES  Yes 

FI  No 
FR  Yes 
HR  No 
HU  No 

Paediatric tx 
Interactions and boundaries between Organs, 
Tissues & Cells, on one side, and healthcare 
products and medicines, on the other side. 
ONT is particularly concerned about Donor 
protection in the mentioned context. Profit in 
the context of voluntary unpaid donation is also 
of interest for the ONT: 

Harmonisation of practices 

17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Further collaboration in relation to medical 
devices / tissues for all listed categories 
Educational programs and communication 
initiatives 

Lung transplantation and paediatric liver 
transplantation for LV patients 

We are cooperating in the field of tissues and 
cells with Institute for Transfusion medicine 
and Public Agency for Drugs and Medical 
products on an almost daily basis. To our 
opinion, it should stay as it is until now. 
Existing legislation is very useful and serves to 
realize all important requirements in the field. 
We would like to intensify cooperation with 
the National institute of public health. 

IE  Yes 

IT  Yes 

LT  No 
LV  Yes 

NL  No 
PL  No 
PT  No 
SE  No 
SI  Yes 

SK  No 

UK(NI): 

1. Have there been any changes to the 
structures/designations of your 
competent authorities since the last 
survey (2014)? 
No  
2. Do you participate in EOEO 
activities? 
Yes 
2.1 Does your country exchange organs 
with other EU Member States? 
Yes 
2.3 Would your country be interested 
in increasing exchanges of organs with 
other Member States in any of the 
following cases? Please select all that 
apply. 
ABO-incompatibility 
Less transplanted organs 

What are these changes? Please provide details 
(including to which competent authority they 
relate, if applicable): 

Do you have an agreement with an EOEO 
(Article 21 of the Directive)? 
Yes  
2.2 Does your country exchange organs with 
third countries? 
Yes  
Please specify in 
which cases you 
would be 
interested: 

Please specify the reasons 
why you see an interest in 
exchanging organs with 
other Member States in this 
case: 

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Children 
Other 

x 

NI already exchanges organs 
at this level. There is 
potential to increase living 
donation and the UK Living 
Kidney Sharing Scheme. NI 
is part of that and there has 
been interest from Republic 
of Ireland although 
discussions are in early 
stages. 

None 
3.  In  the  reporting  period,  was  there  collaboration  between  your  competent 
authority/delegated body and authorities and stakeholders with adjacent areas of expertise 
in your Member State? 
If yes: To what extent does your competent authority/delegated body collaborate with 
authorities and stakeholders with adjacent areas of expertise in your Member State? 
Occasionally  Never  Not applicable 
(e.g., same CA) 

To a great 
extent 

To some 
extent 
x 

x 

Please  specify  which  other 
topics  have  been  subject  to 
collaborative interactions 

which 
specify 
Please 
area/authority  you  would 
consider relevant: 

Blood 
Tissues and Cells 
x 
Medicinal Products  x 
Medical Devices 
Others 
Which  of the following topic(s) have been subject to such 
collaborative interactions? Please select all that apply. 

x 

x 
x 
x 

Vigilance 
Traceability 
Donor protection 
Other 
None 
3.1 Are there (other) areas in which your country would be 
interested to collaborate (more)? 

No 

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. Donor and recipient follow-up 

4. Is a register or record of 
living donors kept in your 
country? 

AT  Yes 
BE  Yes 
BG  Yes 
CY  Yes 
CZ  Yes 
DE  Yes 
DK  Yes 
Yes 
EE 

Yes 
EL 
Yes 
ES 
Yes 
FI 
FR 
Yes 
HR  Yes 
HU  Yes 
Yes 
IE 
Yes 
IT 
LT 
No 
LV  Yes 
NL  Yes 
Yes 
PL 
Yes 
PT 
No 
SE 
Yes 
SI 
SK  Yes 

When was this register or record established? 
Please provide the year of establishment and, if 
possible, the month: 
12/2017 Data may be retrospectively from 01/2017 
July 2012 
Year - 2010 
1/2011 
Since 2004 - the establishment of our organization 
Registry on QA 2006, Transplantation Registry 2019 
1995, January 
We use Scandiatransplant YASWA database since 
2017 
2011 
January 2010. 
since 1964, new register platform 2015 -> 
2004 
register is kept by transplant centres 
2018 
July 1972 
2001 

1973 
2002 
Jan 1st 2007 
July 1969 

Since the first kidney transplantation -1970. 
2007 

Please describe how this register or record works and by which authority it is 
hosted (for example: is it kept at hospital/national/international level? Is it an IT 
tool, or shared excel sheets, or any other system? …) 

AT  After a living donation has been made, certain parameters (before donation, shortly 

after donation, etc.) are entered in pseudonymised form in a central database hosted by 
the Austrian Public Health by the procurement centre. After 3 months respectively a 
year, an automated reminder is sent to the procurement centre with a request to carry 
out the next follow-up check on the living donor in question and to enter the data. The 
same process then takes place every 2 years for the kidneys, so that a long-term follow-
up of all living donors in Austria is guaranteed. 

BE  We are working with Eurotransplant, every transplantation centre gives the follow-up 

data to the register 

20 

 
 
 
 
 
 
 
 
Shared excel sheets 

BG 
CY  Hosted by the Transplant Clinic in Nicosia General Hospital, it is on an excel sheet 
CZ 

It is kept in our organization generally for CZ, also in TC for their own. 
IT tool + excel sheets 

DE  On the national level the register on liver and kidney living donation as part of the 

mandatory quality assurance measures covered by Section 137a of the Fifth Book of 
the Social Code is presently hosted by the Institut für Qualitätssicherung und 
Transparenz im Gesundheitswesen (IQTIG) under the responsibility of the Federal 
Joint Committee. 

In addition, the national Transplantation Registry was established in 2019. The 
Gesundheitsforen Leipzig GmbH have been assigned by the Central Federal 
Association of the Health Insurance Funds, the German Medical Association, and the 
German Hospital Federation to host the national Transplantation Registry under 
Section 5b of the Transplant Act. The registry is presently being built up. 

On the hospital level all transplant centres are obliged under para. 10 subsection 2 of 
the Transplant Act to record all living donations performed in their centre. 
The register is hosted and managed by Scandiatransplant (in Aarhus, Denmark) in a 
dedicated IT-tool. 

DK 

This system is used by all transplant centres in Denmark, Sweden, Norway, Finland, 
Iceland, and Estonia. 

Regarding follow up information - there is a delay in data entry of follow up 
information (see below) 
Data is collected and entered by Transplantation centre and the register belongs to 
Scandiatransplant. 
It is kept at a national and hospital level 
The staff of the hospitals that make living donations upload the information in a 
database that may be the ONT's or a regional one which loads in a second step in the 
ONT's database. The ONT make the data management, the record linkage, the 
statistical analyses, and the periodical reports. 
Transplant surgery is centralized nationally in the Helsinki University Hospital. 
Register is kept by this hospital (organ transplantation centre, at national level). 
Hosted by Agence de la Biomédecine. The data is provided by hospitals. 
IT tool 
It managed centrally and nationally by the HNBTS 

It is a dedicated module of the national organ donor registry 
It is kept at National kidney Transplantation unit Beaumont Hospital. It is an IT 
database. 
The register is held at national level, it is a part of the national transplant info system, 
hosted by the Italian Ministry of Health, the information gathered include data about 
follow-up of living donor and the reporting of serious adverse events if linked to 
donation (e.g.: infection, death of donor) 

EE 

EL 
ES 

FI 

FR 
HR 
HU 

IE 

IT 

21 

 
 
 
 
 
 
 
LT 
LV 

NL 

PL 

PT 
SE 
SI 

SK 

There is only one transplantation centre in Latvia (P. Stradin's University Hospital). 
The register contains information about all cases of donation/transplantation (date, 
relation between donor and recipient) since the beginning in 1973. The register 
currently is in electronic format (Excel) and is kept by the Latvian Transplantation 
centre. 

Medical follow-up records are kept in electronic hospital system. 

Follow-up is organised according to Latvian Transplantation centre's quality and safety 
procedures. 
It is a section of the follow up registry of the Dutch Transplant Foundation: the 
National Organ Transplantation Registry (NOTR) 
Concept of organ donor registry is achieved with the use of a tele-informatic tool 
(www.rejestrytx.gov.pl). Donation centres are obligated to collect donors’ data 
(demographic and medical) peri-, and post-donation and long-term every year follow-
up). 

The administrators of the register are Ministry of Health and Poltransplant. 

The database consists of sections containing information on the living kidney donor, 
the recipient, and the relationship between the donor and the recipient. Donor and 
recipient data include: name, surname, personal identification number (PESEL), date of 
birth, age, sex, place of residence, and date of death if applicable. Information on the 
date and centre of procurement and transplantation were also included in the database. 

The registry currently handles completed data from 2008 (records and follow up) and 
all historical procurements 
Electronic health records 

It is stored at the University Medical centre at Department for nephrology, where 
kidney transplants are performed. Documents are kept as paper folders. 
Regional (transplant centres) full medical documentation 

National Transplant organization record and follow up 

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Among all living donors who 
donated an organ during the 
last year for which you have 
complete data (2021, otherwise 
2020) in your country, which 
percentage: are included in 
your register/record? Report 
percentage 

AT 

100 

see Eurotransplant 

100% 
100% 
100 
100 
100 
100% 
100 
100 
100 
94% 

BE 
BG  No 
100 
CY 
CZ 
100 
DE  No Data presently available 
DK 
EL 
EE 
ES 
FI 
FR 
HR 
HU 
IE 
IT 
LT 
LV 
NL 
PL 
PT 
SE 
SI 
SK 

100 
67% 
100% 
100% 

100 
100 

The data 
reported for 
living donors 
relate to the 
year: 

2020 

2020 
2021 
2021 
2021 
2020 
2020 
2021 
2021 
2020 
2021 
2021 
2020 
2021 
2021 
2020 

2021 
2020 
2020 
2021 

2020 
2020 

Among all living donors 
who donated an organ 
during the last year for 
which you have complete 
data (2021, otherwise 2020) 
in your country, which 
percentage: have a correct 
set of completed follow-up 
data? Report percentage 
the completeness of follow up 
data will be calculated for the 
first time in 2022 - data can 
be submitted in May 2022 
see Eurotransplant 
No 
100 
100 
No Data presently available 
70% 
100% 
100 
72 
100 
n/a 
100 
Few 
100 
71% 

100 
67% 
98% 
50% 

100 
50 

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please specify the changes to the follow-up of living donors: 

By starting the living donor registry defined and standardized 
examination times have been determined and established (before 
donation, shortly after donation, 3 months after donation and then 
every 2 years) 

The registry also covers the field of stem cell donors, also starting 
in December 2017, examination periods there is 2017 to 2020 at 
the moment. Also, there defined and standardized examination 
times have been determined and established (before donation, day 
1 to 30 after donation, 1 year after donation). Initially, annual 
follow-ups were planned, since 2021 follow ups of stem cell 
donors are planned every 5 years instead. 

Annual check-up system was established in 2017. 

In 2010, this registry was integrated into the ONT information 
systems', deriving in a general improvement in terms of 
governance, record linkage and data base operations. Variables 
and follow-up are essentially the same. 

Better long-term follow up. 

The implementation itself 

5. Were there 
any changes to 
the follow-up of 
living donors 
since 2014? (For 
example, in the 
frequency or 
duration of 
follow-up? 

AT  Yes 

BE  No 
BG  No 
CY  No 
CZ  No 
DE  No 
DK  No 
Yes 
EE 
No 
EL 
Yes 
ES 

No 
FI 
FR 
Yes 
HR  No 
HU  Yes 
No 
IE 
No 
IT 
LT 
No 
LV  No 
NL  No 
No 
PL 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PT 

Yes 

No 
SE 
SI 
No 
SK  No 

The National Programme for non-directed or anonymous renal 
donation has been implemented. Specific rules were defined for 
the psychological and/or psychiatric follow-up of these donors. 

6. Is a register or record of organ 
recipients kept in your country? 

When was this register or record 
established? Please provide the year of 
establishment and, if possible, the month: 

AT  No 
BE  No 
BG  Yes 
CY  Yes 
CZ  Yes 

DE  Yes 

DK  Yes 
Yes 
EE 
Yes 
EL 
Yes 
ES 
Yes 
FI 
FR 
Yes 
HR  Yes 
HU  Yes 
Yes 
IE 
Yes 
IT 
LT 
Yes 
LV  Yes 

NL  Yes 
Yes 
PL 
Yes 
PT 
SE 
SI 
Yes 
SK  Yes 

Year 2010 
1/2011 
Since 2004 - the establishment of our 
organization 
Registry on QA 2006, Transplantation Registry 
2019 
1995, January 
2017 
2011 
Liver started in 2005, while kidneys in 2010. 
Since 1965, new register platform 2015-> 
1996 
on transplant centres level 
2018 
July 1972 
2002 
Heart, Lungs 
Kidneys and pancreas 1973, heart 2002, liver 
2018. 
NOTR exists since 2002 
2006 
2018 

2018 
1995 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For which organs does such a register or record 
exist? Please select all that apply. 

Please indicate for which 
other(s) organ(s) there is a 
register or record: 

AT 
BE 
BG  Kidneys 

Livers 
Others 

CY  Kidneys 

Livers 
Others 

CZ  Kidneys 

Livers 
Others 

DE  Kidneys 

Livers 
Others 

DK  Kidneys 

Livers 
Others 

EE 

Kidneys 
Livers 
Others 

EL 

ES 

FI 

FR 

Kidneys 
Livers 
Others 
Kidneys 
Livers 
Others 
Kidneys 
Livers 
Others 

Kidneys 
Livers 
Others 

x 
x 
x  Heart 
x 

x 
x 

x 
x 
x  Hearts, Lungs, Pancreas, 

Intestines 

x 
x 
x  Heart 
Lung 
Pancreas 
Pancreatic islet 
Intestine 

x 
x 
x  All recipient records are kept in 

YASWA, but there is an 
additional national register for 
kidneys.   

x 

x 
x 

x 
x 
x  All transplant recipients are 
registered: kidney, pancreas, 
liver, heart, lung, intestine, face. 

x 
x 
x  All transplantable organs 

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HR  Kidneys 

Livers 
Others 

HU  Kidneys 

IE 

IT 

LT 

Livers 
Others 
Kidneys 
Livers 
Others 
Kidneys 
Livers 
Others 

Kidneys 
Livers 
Others 

LV  Kidneys 

Livers 
Others 

NL  Kidneys 

PL 

PT 

SE 
SI 

Livers 
Others 
Kidneys 
Livers 
Others 

Kidneys 
Livers 
Others 

Kidneys 
Livers 
Others 

SK  Kidneys 

Livers 
Others 

heart, lung, pancreas 

x 
x 
x 
x 
x 
x  Lungs, pancreas 
x 

x 
x 
x 

x 
x 

heart, lung, small bowel, 
pancreas 

x 
x 
x  Heart and pancreas. 
x 
x 
x 
x 
x 
x 

heart, lungs 

hearts, lungs, pancreas, 
vascularized tissue allografts 

x 
x 
x 

x 
x 
x 

heart, lung, and pancreas 

hearts, lungs, pancreas in 
combination with kidneys 

x 
x 
x  Heart, pancreas 

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please describe how this register or record works and by which authority it is 
hosted (for example: is it kept at hospital/national/international level? Is it an IT 
tool, or shared excel sheets, or any other system? …) 

AT 
BE 
BG  National level – IT tool and Excel sheets, kept by Executive Agency ‘Medical 

Supervision’ and the hospitals 

CY  Hosted by the Transplant Clinic in Nicosia General Hospital, it is on an excel sheet 
CZ 

It is kept in our organization generally for CZ, also in TC for their own. 
IT tool + excel sheets 

DE  On the national level the register on kidney, liver, heart, and lung donation as part of 
the mandatory quality assurance measures covered by Section 137a of the Fifth Book 
of the Social Code is presently hosted by the Institut für Qualitätssicherung und 
Transparenz im Gesundheitswesen (IQTIG) under the responsibility of the Federal 
Joint Committee. 

DK 

EE 

EL 
ES 

In addition, the national Transplantation Registry was established in 2019. The 
Gesundheitsforen Leipzig GmbH have been assigned by the Central Federal 
Association of the Health Insurance Funds, the German Medical Association, and the 
German Hospital Federation to host the national Transplantation Registry under 
Section 5b of the Transplant Act. The registry is presently being built up.  
The register is hosted and managed by Scandiatransplant in a dedicated IT-tool. 

Additionally, all liver, heart, and lung transplantations before 1995 have been 
reconstructed in the database. 

There are not follow up registries on all organ type within Scandiatransplant, but graft 
and patient survival are updated on all (95%) 
Data is collected and entered by Transplantation centre and the register belongs to 
Scandiatransplant. Scandiatransplant is responsible for hosting. 
It is kept at a national and hospital level 
These systems are integrated into the "National Donation and Transplant Information 
System" which, in accordance with Royal Decree 1723/2012, is hosted, maintained, 
developed, and safeguarded by the ONT. Also, the operating procedures are agreed 
upon between the ONT and the autonomous communities. The system is uploaded with 
information coming from the hospitals, directly or indirectly (uploaded from an 
autonomous community). The data are periodically analysed, and the corresponding 
exports are made public annually.  

The systems fully respect the data protection regulation.   
Transplant surgery is centralized nationally in the Helsinki University Hospital. 
Register is kept by this hospital (organ transplantation centre, at national level) 
Register hosted by the Agence de la Biomédecine. It is an IT tool comprised of several 
different applications. 
IT tool 

FI 

FR 

HR 

28 

 
 
 
 
 
 
 
 
 
HU 

It managed centrally and nationally by the HNBTS 

IE 

IT 

LT 
LV 

There is a separate module of the national organ donor registry called transplantation 
follow up registry 
It is kept at National kidney Transplantation unit Beaumont Hospital. It is an IT 
database. 
The register is held at national level, it is part of the national transplant info system, 
hosted by the Italian Ministry of Health 
National, IT tool 
In Latvia we use living donors only for kidney transplantation and only in the one and 
only transplantation centre of P. Stradin's University Hospital. The register contains 
information about all cases of donation/transplantation (date, relation between donor 
and recipient) since its establishment in 1973. The register currently is in electronic 
format (Excel), kept by the Latvian Transplantation centre. 

Medical follow-up records are kept in electronic hospital system. 

Follow-up is organised according to Latvian Transplantation centre’s quality and safety 
procedures. 

Register for all transplanted kidneys and pancreas exists since 1973 (paper format for 
1973-2014, electronic since 2014), heart - since 2002, liver - since 2018. 
NL  National level, hosted by the DTF, IT tool, data are collected form the transplant 

PL 

PT 

SE 
SI 

centres 
In 2006 National Transplants Registry was created in Poland for proper monitoring and 
evaluation of transplantations performed in Poland [1,2]. Transplants Registry has two 
main functions: (1) gathering information on every organ transplantation performed 
within the country (registration function) and (2) monitoring of quality of performed 
transplantations by collecting data on graft function and recipient’s survival in the 
short- and long-term follow-up (in the day of transplantation, 3 and 12 months after 
transplantation and every following year till graft loss or recipient death) (follow-up 
function). 

According to current legal regulations the entity responsible for administering of 
Transplants Registry is Polish Transplant Coordinating Centre Poltransplant (national 
competent authority in donation and transplantation), which cares about personal data 
safety, prevents data loss or destruction, and performs statistical analysis. 
The register is made using a digital platform (RPT) from the donor institutions to the 
transplant units and centralized in the Portuguese Transplant Coordination. 

It is kept at hospital level, but the system serves as the national level because we have 
only one University Medical centre where transplants of solid organs are performed. 

Excel sheets and paper folders on the national level and IT system used at 
Eurotransplant- completeness at ET is about 70-80% (2018). 

29 

 
 
 
 
 
 
 
 
 
SK  National level National transplant registry, waiting list for organs, donor register, 

transplantation register. 

Detailed medical records at transplant centres. 

Among all recipients who 
received an organ during the 
last year for which you have 
complete data (2021, 
otherwise 2020) in your 
country, which percentage: 
are included in your 
register/record? Please give a 
percentage: 

Among all recipients who 
received an organ during the 
last year for which you have 
complete data (2021, 
otherwise 2020) in your 
country, which percentage: 
have a correct set of 
completed follow-up data? 
Please give a percentage: 

The data reported 
for recipients 
relate to the year: 

100% 
100  
100  

AT 
BE 
BG 
CY 
CZ 
DE  No Data presently available 
DK 
EE 
EL 
ES 
FI 
FR 

100% 
100  
100% 
100  
100  
100% 

HR 
HU 
IE 
IT 
LT 
LV 
NL 
PL 
PT 
SE 
SI 
SK 

100  
100  
100  
99,5% 
22,2 
100 
87-96 % 
100% 
100% 

100 
100 

2021 
2021 
2021 
2020 
2020 
2021 
2021 
2020 
2021 
2021 

2020 
2021 
2021 
2020 
2021 
2021 
2020 
2020 
2021 

2020 
2020 

No 
100  
100  
No Data presently available 
95% 
100 
100% 
100 
100 
65% for kidney recipients 
100% for liver recipients 41% 
for heart recipients 100 % for 
lung recipients 
100 
100 
100 
74% 
100 
100 
87-96% 
100% 
100% 

100 
70 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UK(NI):  

When was this register or record established? Please 
provide the year of establishment and, if possible, the 
month: 
June 1976. Maintained by NHSBT. 

4. Is a register or record of 
living donors kept in your 
country? 
Yes 
Please describe how this register or record works and by which authority it is hosted (for 
example: is it kept at hospital/national/international level? Is it an IT tool, or shared 
excel sheets, or any other system? …) 
It is a national registry stored in an oracle database with HTA requirement to report all living 
donors in a timely manner.  Follow-up is collected at 1 year, 5 years and every 5 years 
thereafter for living donors. Number in registry for NI is 53 in 2021. 
Among all living donors 
who donated an organ 
during the last year for 
which you have complete 
data (2021, otherwise 2020) 
in your country, which 
percentage: are included in 
your register/record? 
Please give a percentage 

The data reported for living 
donors relate to the year: 

Among all living donors 
who donated an organ 
during the last year for 
which you have complete 
data (2021, otherwise 2020) 
in your country, which 
percentage: have a correct 
set of completed follow-up 
data? Please give a 
percentage 
We have 100% follow-up 
immediately post-transplant, 
but for the majority, 1 year 
follow-up will not yet be due. 

2021 

We expect this is 100% of 
transplants as there is a 
regulation that all transplants 
must be reported to NHSBT. 
5. Were there any changes to the follow-up 
of living donors since 2014? (For example, 
in the frequency or duration of follow-up? 
Yes 

6. Is a register or record of organ 
recipients kept in your country? 

Yes 
For which organs does such a register or 
record exist? Please select all that apply. 
Kidneys 
Livers 
Others 

x 
x 
x 

Please specify the changes to the follow-up 
of living donors: 

We started the expanded paired/pooled and 
altruistic donor schemes in the UK on 1 April 
2015 and so started collecting additional 
information around these transplants.  Also 
introduced collection of DROMS and 
DREMS in November 2019. 
When was this register or record 
established? Please provide the year of 
establishment and, if possible, the month: 
August 1970 
Please indicate for which other(s) organ(s) 
there is a register or record: 

Heart 
Lung 
Pancreas 

31 

 
 
 
 
Intestinal 

Please describe how this register or record works and by which authority it is hosted (for 
example: is it kept at hospital/national/international level? Is it an IT tool, or shared 
excel sheets, or any other system? …) 
It is a national registry stored in an oracle database with HTA requirement to report all 
recipients of a transplant in a timely manner.  Follow-up is collected at 3 months, 12 months, 
and every year thereafter for transplant recipients. Number on registry for NI in 2021 is 106. 
Among all recipients who 
received an organ during the last 
year for which you have complete 
data (2021, otherwise 2020) in 
your country, which percentage: 
are included in your 
register/record? Please give a 
percentage: 
This is 100% of transplants as there 
is a regulation that all transplants 
must be reported to NHSBT. 

Among all recipients who 
received an organ during the last 
year for which you have complete 
data (2021, otherwise 2020) in 
your country, which percentage: 
have a correct set of completed 
follow-up data? Please give a 
percentage: 
We have 100% follow-up 
immediately post-transplant, but for 
the majority, 1 year follow-up will 
not yet be due. 

The data 
reported for 
recipients relate 
to the year: 

2021 

3. Biovigilance 

7. Were there 
any changes to 
the reporting 
system for 
information 
concerning 
SARE since the 
last report? 

AT  No 

BE  No 
BG  No 

7.1 Please briefly outline how your reporting system works in 
practice. Please explain at what level the system is organised (e.g., 
EOEO, regional, or other): 

The implementation works in line with the legal framework, between 
EOEO (Eurotransplant), the Competent Authority and the 
transplantation centres. 
Reporting to Eurotransplant 
Every establishment (procurement organizations or transplantation 
centres), that has license to work in the field of transplantation of 
organs, tissues and cells has the obligation to report if a serious 
adverse reaction (SAR) or incident (SAE) occurs. All establishments 
send reports to the Medical Supervision Executive Agency, which is 
the competent authority in the field of organ, tissue and cell 
transplantation and assisted reproduction for Bulgaria. The Agency 
shall register, investigate, and inspect each individual case of SAR or 
SAE. If other Member States are involved, this case is reported 

32 

 
 
 
 
 
CY  No 
CZ  No 
DE  No 

DK  Yes 

EE  Yes 

EL  No 
ES  No 

FI  No 

through the RATC system (Rapid Alert Tissues Cells). Our system is 
organized at a national level. 
Regional 
regional and national cooperation 
The German organ procurement organization (Deutsche Stiftung 
Organtransplantation (DSO)) in close cooperation with 
Eurotransplant is responsible at the national level for reporting, 
investigating, documenting, and transmitting relevant and necessary 
information concerning serious adverse events and serious adverse 
reactions that may influence the quality and safety of organs in 
accordance with para.9 and para. 10 of the Regulation on the Quality 
and Safety of Organs under the Transplant Act. In case of cross-
border organ exchange all centres from the different countries that 
received an organ are involved. The initial and final report is 
provided by the Competent Authority / Delegated Body of the 
respective donor country. 
The SARE reporting are handled through the Scandiatransplant 
systems and reported to centres and CAs 
All the SARE reports and final investigation reports are sent to State 
Agency of Medicines, where they are assessed and registered. 
Relevant information that may influence the quality and safety of 
organs is exchanged between transplant centres. All this must be 
covered with handler's biovigilance system. This is a national system 
and requirements are outlined in the law.  

For organs, which are sent to other countries notification system was 
established by Scandiatransplant, so all transplant centres and 
competent authorities receive the first notification at the same time. 
Further communication and investigation depend on the countries 
involved. 
National level 
The system is organized at three levels, as a mirror of the 
transplantation system and the healthcare system in the country. 
Cases appear at the hospital level but are transmitted bottom up for 
analysis and evaluation at the regional / national level, depending on 
the geographical and administrative distribution of the cases affected 
(whether it is within a particular region or affects several regions). 
The immediate measures are taken at hospital level and reported. The 
measures are agreed upon by the affected levels. The follow up 
contacts are made as per a national protocol agreed upon by all 
regions. A final report of every case is delivered. The system is 
advised by a committee of experts. 
FIMEA receives national SARE-reports from organ transplantation 
centre (Helsinki University Hospital) and all Scandinavian SARE-
reports from Scandiatransplant. 

33 

 
 
 
FR  Yes 

HR  No 
HU  No 

IE  No 

IT  No 

LT  No 
LV  No 

NL  No 

PL  No 

In 2016, the Agence de la Biomédecine became the CA for Organs 
vigilance. The system is a national one: the CA coordinates vigilance 
organization at national level, develops tools, provides help for 
SAREs investigations, publishes an annual report, organizes 
training… Locally, there are local biovigilance coordinators (MD or a 
nurse under the responsibility of a MD) located in each health 
establishment in charge of organs procurement and transplantation. 
These vigilance coordinators must collect and notify to the CA, 
SAREs that occur along the chain from the selection of donors to the 
follow-up of the recipients. They are implicated in the investigations 
and whenever possible in the management of correctives measures. 

There is another system for alerts. It is a 24/24 system managed by 
ABM (at CA level) in charge of allocation of the procured organs. 
There are operational links between vigilance system and alert system 
since an alert can lead to a vigilance notification (e.g., following a 
bacterial or viral contamination of the graft, following tumour 
identified on the graft). The purpose of both systems is 
complementary, one (ALERT) gives information to the clinician in 
charge of the recipients to help them quickly adapt the recipient care, 
second (VIGILANCE) is to improve the system (process, 
organization, etc.) and avoid recurrence of deleterious events. 
EOEO, national level 
Nationally and internationally as well in cooperation with 
Eurotransplant 
The CA function is delegated through Department of Health to Organ 
Donation Transplant Ireland (Clinical) Health Product regulatory 
authority (Non-Clinical). Dual reporting to which then determine 
clinical/non-clinical status. Clinical reports are managed through the 
National Organ Donation Transplantation Advisory Group which 
oversees investigations, corrective/preventative actions and 
continuous improvement measures agreed. 
An ad-hoc reporting function has been developed in the national 
transplant info system, where hospitals can report to Clinical Risk 
Manager and Regional Transplant Centre. A national protocol has 
been adopted for the purpose of reporting and managing adverse 
events and reactions. 
National and international 
National, through the delegated body - P. Stradin's University 
Hospital, National Transplant Coordination Department 
First alert sent by Eurotransplant; final report by Dutch Transplant 
Foundation for Dutch donors 
Polish legal regulations are adapted to Directive. The regulations 
define SARE and the procedures by which SARE should be 
monitored (in organ donation, procurement, testing, preservation, 
distribution, and transplantation), impose registration requirements on 

34 

 
 
 
 
donation and transplant centres and require reporting of SARE with 
detailed information describing events or reactions as well as the 
procedures enacted to resolve and prevent future problems. 
Poltransplant is the authority that refers and manages the data on 
SARE related to organ transplantation in web-netted tool. The 
National Transplantation Council appointed by the Minister of Health 
analyses the aggregate data on SAREs to evaluate its effect on the 
quality and safety of the transplantation system and submits proposals 
for improving the quality of the current system. 
National 
- 
EOEO-reporting, collecting data and cases investigation, co-
preparing corrective measures 

National: 24/7 reactivity on the level of Slovenija transplant, 
reporting to and from donor and transplant centres, collecting data, 
investigation of cases, preparing corrective measures to increase 
quality and safety for patients in cooperation with clinicians, issuing 
annual reports, 
System is organized at national level. Due to law all medical 
providers must report SARE to National transplant organization. 

PT  No 
SE  No 
SI  No 

SK  No 

8. Do you have 
operating 
procedures in 
place for the 
notification, in 
due time, of 
any SARE to 
the Competent 
Authorities 
and to the 
concerned 
procurement 
organisation or 
transplantation 
centre? 

AT  No 

8.1 Do you 
have 
operating 
procedures 
in place for 
the 
notification, 
in due time, 
of the 
management 
measures 
with regards 
to SARE to 
the 
Competent 
Authority? 
No 

8.2 Please explain how this notification system works in 
practice: 

Notification of SARE must be done immediately with the 
report of the EOEO (Eurotransplant) and within three working 
days to the delegated body. 

Additionally, there is an exchange of information in case of 
involvement of tissue procurement. 

35 

 
 
 
 
 
 
BE  Yes 

BG  Yes 

CY  Yes 
CZ  Yes 

Yes 

Yes 

Yes 
Yes 

DE  Yes 

Yes 

DK  Yes 

Yes 

EE  Yes 
EL  Yes 

ES  Yes 

Yes 
Yes 

Yes 

Each SARE coming in from Eurotransplant is discussed in a 
national workgroup 
In Bulgaria we have published normative acts in which it is 
defined in which case it is reported, there are published 
serious adverse reaction or event (SAR/E) forms, there are 
certain responsible persons who are responsible for reporting, 
deadlines and the sequence of actions are determined. 
Reports are sent to MOH 
SARE have been implemented into Czech legislation through 
Regulation No. 111/2013 Coll. (on setting requirements for 
working procedures to ensure the system of quality and safety 
of human organs intended for transplantation) as of April 30, 
2013. SARE has been implemented into practical procedure 
of reporting serious details of an adverse reactions/effects 
(SARE) on the special forms - reporting measures taken in 
respect of the incident. Both forms have been distributed to 
individual transplant centres, the centres were instructed how 
to report, and filled-in reports are being regularly checked by 
KST. Apart from that, empty forms are easily accessible on 
the website of KST. The Ministry of Health is informed about 
the most serious events. 
The DSO has – based on the German Transplant Act – issued 
guidelines for the reporting of SAEs and SARs by donor 
hospitals, laboratories/pathologies, and transplant centres to 
the DSO. After the initial reporting the DSO takes care of the 
work-up of the cases as described und 7.1 
All the transplant centres in the Scandiatransplant area are in 
direct contact with each other 24/7 by phone, e-mail etc. as 
follows: 

Non-urgent: E-mail is sent out the day after reporting at 10.00 
to CAs and transplant coordinators 

Urgent: E-mail is sent to CAs and E-mail + SMS is sent to all 
transplant coordinators at time of reporting 
Please see answer to question 7.1. 
Direct and immediate reporting to any involved professional 
and authority 
The answer considers notifications bottom up, and top down. 
The donor transplant coordinator detects a possible case and 
makes an initial notification triggering the system. Initial 
measures are decided by the hospital and notified bottom up. 
Those include a notification to the centres possibly affected 
and to the Tissues and cells system. The biovigilance contact 
person fills up a predesigned form. After the analysis of the 
case at an upper level, the measures to be taken are decided, 

36 

 
 
 
 
FI  Yes 

Yes 

FR  Yes 

Yes 

HR  Yes 

HU  Yes 

IE  Yes 

Yes  

Yes 

Yes 

IT  Yes 

Yes 

agreed upon, notified top down, and then carried out. The 
case is supervised and followed up as per a national protocol. 
A final report is made and issued to all the centres affected. 
Organ donation hospitals report all events to organ 
transplantation centre (Helsinki University Hospital). Organ 
transplantation centre reports all SARE to FIMEA (CA). 
Operating procedures for the notification are inspected 
regularly during official inspection. 
ABM’s IT application centralizes SAREs notifications and 
allows national analysis and publishes annual national 
vigilance report 

In the IT system, the local biovigilance coordinator (LBC) 
describes SAR or SAE. The CA can identify the donor or the 
recipient and can access us with additional information (like 
medical history) through living donors registry, deceased 
donors’ registry, or recipients’ registry. The application 
informs the concerned procurement or transplant centre that 
can follow each step of the investigation.  

In the application, the LBC can assess imputability and 
severity for SAR. For the SAE, the LBC can detail the steps 
where the SAE occurred and mention possible causes.  

Each LBC needs to provide an annual report summarizing 
relevant corrective measures implemented in their 
establishment. 

Since 2021, CA organises training on vigilance for the LBCs. 
We also published a guide to help them in their biovigilance 
tasks. 
Rapid alert from donor or transplant centres to NCA and 
Eurotransplant 
All identified SAE/R cases are reported to the HNBTS, which 
investigate all cases, prepare reports that are sent to the 
Ministry of Human Capacities 
Currently notification is through the National Organ Donation 
Transplant Advisory Group and local centre procedures. The 
biovigilance system is currently undergoing review. Objective 
to further align with latest guidance and best practice. 
All adverse events/reactions should be reported and classified 
in terms of seriousness/likelihood of recurrence. Actions by 
regional and national CAs are requested on the basis of higher 
scores. A panel of 6 experts at national level revises the self-

37 

 
 
 
 
 
 
 
 
LT  Yes 

Yes 

LV  Yes 

Yes 

NL  Yes 

PL  Yes 
PT  Yes 

SE  No 
SI  Yes 

Yes 

Yes 
Yes 

No 
Yes 

SK  Yes 

Yes 

evaluated scores and takes decisions about remedial action 
and audits (if necessary). 
If SARE happens, centre must inform competent authority 
and institution which took, distributed, or received organ, 
tissue, or cells without any delay. After that, centre should 

carry out an investigation and notify the competent authority 
with reasons of SARE and conclusion. 
We have only one procurement organization - P. Stradin's 
University Hospital, National Transplant Coordination 
Department, which manages all reports and SARE 
investigations. P. Stradin's University Hospital is also 
delegated body for tasks regarding Article 5,6, 7 of Directive 
2012/25/EU including SARE reports) and acts as a 24/7 
contact-point required by Directive 2012/25/EU 
(http://www.txcontactlist.eu/index.php?action=details&id=lv). 
In order to provide information also for State Agency of 
medicines (SAM) as the competent authority in the field of 
organ transplantation as per Directive 2010/53/EU Article 17, 
SAM maintains online SARE reporting (Annex I, and II of 
Directive 2012/25/EU; bilingual - Latvian, English) tool with 
possibility to download report in PDF after submitting and 
subsequently to send it to other transplant centres and 
procurement organizations in case of organ exchanges 
(https://dati.zva.gov.lv/biovg/?&t=org-bn-s and 
https://dati.zva.gov.lv/biovg/?&t=org-bn-f ). 
Written procedure and national registration of incoming 
SAER; short annual report 
As it is described in 7,1 
Notified in the digital platform (Biovigilância), with a specific 
codex, to be analysed and validated by the competent 
authority. 
- 
Usually, Slovenija transplant is receiving first info. Based on 
the nature of case or situation the first report is sent to the 
target centre in Slovenia or to Eurotransplant. The collection 
of data is starting in cooperation with clinicians. If the 
situation is not urgent then we are collecting data and 
preparing final report in due time. If the situation is urgent, 
we send alarm to target centres and Eurotransplant to stop 
using organs, send to pathology and based on the results 
prepare the report. Our communication with all involved 
experts and centres is made on the non-blaming principle and 
we try to be precise and correct as much as it is possible. 
National transplant organization is working at 24/365 basis. In 
case of SARE the duty office can connect every procurement 

38 

 
 
 
9. Is an interconnection 
in place between the 
reporting system for 
organ transplantation 
of Directive 2010/53/EU 
and the notification 
system established for 
the transplantation of 
tissues and cells in 
accordance with Article 
11(1) of Directive 
2004/23/EC?   

AT  Yes 

BE  Yes 
BG  Yes 

CY  No 
CZ  No 
DE  Yes 

DK  Yes 

and transplant centre. Also is in connection with transplant 
coordinators. Management goes on in close coordination with 
relevant medical and other actors. 

Please specify how this interconnection is organised: 

The information exchange is between the delegated body 
organs and tissue vigilance and is done by email. 
tissue banks are informed by the transplantation centre 
All establishments (procurement organizations or 
transplantation centres) send reports to the Medical 
Supervision Executive Agency, which is the competent 
authority in the field of organ, tissue and cell transplantation 
and assisted reproduction for Bulgaria. The Agency is one 
institution (Competent Authority) for organs, tissues and 
cells and there is no need to make a connection between 
them. We don’t have connection with Blood sector. 

According to para 40 subsection 3 of the Drug and Active 
Ingredient Manufacturing Regulation the tissue 
establishments are obliged to report SAE/SAR to the DSO, 
in case the tissue or cell donor had also donated organs. 
Respectively the DSO is obliged according to para. 9 
subsection 3 of the Regulation on the Quality and Safety of 
Organs under the Transplant Act to report SAE/SAR to the 
tissue establishment in case the organ donor had also 
donated tissues or cells. For this purpose, a designated 
system has been established to allow a reliable linkage 
between the organ procurement organization and the 
different tissue banks in case a donor donated both organs 
and tissues or cells. 
There is not an "automated electronic" link. Relevant 
information will be passed through phone or mail (see 
above). 

39 

 
 
 
 
 
 
EE  Yes 

EL  No 
ES  Yes 

FI  Yes 

FR  Yes 

HR  No 
HU  Yes 

IE  Yes 

IT  Yes 

LT  Yes 

LV  Yes 
NL  No 
PL  Yes 

PT  No 
SE  No 
SI  Yes 

SK  Yes 

It's the same reporting system with the principal 
requirements outlined in the law. If SARE that may affect 
organs is found by tissue handlers, organ transplantation 
centre is also notified. 

The CA is the same, so, as soon as a case is reported, 
possible affected T&C recipients or tissue establishments are 
identified and notified as well as organ transplantation 
centres.  
All SARE (organ/tissue) reports are reviewed by same 
authority (same register) and same official. 
Agence de la Biomédecine is the CA for organs, tissues and 
cells, and the same biovigilance tool is used in all those 
fields. 

As many of organ donors are also tissue donors, we involve 
all tissue establishments, if they procured tissue 
There is an arrangement between both functions which will 
be further developed as a result of service review. 
The Competent Authority in charge of both notification 
systems is the same. 

A flow chart has been developed to ensure proper 
notification between different involved actors. 
Same procedure of reporting SARE between organs and 
tissues and cells 
It is managed by the same biovigilance officers in SAM. 

Tissue donation from organ donors is coordinated by the 
same institution (Poltransplant). Info on SARE in organs are 
referred to Poltransplant and via this institution to tissue 
entities - and vice versa. 

We have a common 24/7 on-call team for organs and tissues 
and cells vigilance system. In this way, the system is very 
rational and practical. For Slovenia is only realistic to 
organize a common system in order to cover requirements 
for being vigilant and able to react in all urgent cases. 
National transplant organization has the register of deceased 
and living donors of tissue and can connect the TE and 
transfer information and manage the SARE. 

40 

 
 
 
 
 
 
 
 
 
 
10. Please describe the procedure for you to contact 
competent authorities/delegated bodies of other 
Member States in case of a related SARE within 
your country that might affect other Member 
States: 

AT  The information exchange is done via EOEO 

(Eurotransplant). 

BE  The transplantation/donor centre informs 

Eurotransplant which in turn the other centre or 
country 

BG  The Medical Supervision Executive Agency will 
report by the RATC system (Rapid Alert Tissues 
Cells). The Agency is going to create a new signal to 
the other affected Member States. 

CY  Communication between Cyprus MOH and the 
Competent Authority of the other member state 
regarding SARE 

CZ  NA 
DE  s. 7.1 – The key element guaranteeing the information 
and involvement of the CAs of all countries that either 
donated or received an organ in case of an SAE/SAR 
is the international organ allocation office 
Eurotransplant (Leiden/The Netherlands) 
Eurotransplant is responsible for the allocation of the 
organs and the documentation of all parties involved, 
allowing full linkage between donor and recipient. The 
individual donor country is responsible for the work-
up of the case. Eurotransplant facilitates the process, 
so that the DBs/CAs of all countries are involved. The 
procedure is regulated in para. 10 of the Regulation on 
the Quality and Safety of Organs under the Transplant 
Act. 

DK  This is rarely - if ever - needed because the transplant 
centres in the Scandiatransplant area have well 
established procedures for such events. If needed the 
CAs can contact each other individually by phone or 
mail. 

EE  For organs, which are sent to other countries 
notification system was established by 
Scandiatransplant, so all transplantation centres and 
competent authorities receive the first notification at 

41 

10.1 Please describe the 
procedure for you to be contacted 
by competent 
authorities/delegated bodies from 
other Member State(s) in case of 
a related SARE within the other 
Member State(s) that might 
affect your Member State: 
The information exchange is done 
via EOEO (Eurotransplant). 
Eurotransplant inform me which 
SARE from which country and I 
send the information to the 
transplant/donor centre 
When we receive a signal through 
the RATC system that includes our 
country, we register it, analyse it, 
investigate it, and take action, if 
necessary, in each case. 

s. 7.1 

Ensure that the relevant transplant 
centre is also informed in a relevant 
manner. 

Competent authorities/delegated 
bodies from other Member States 
will be contacted if there is a need 
for it. The decision to contact other 

 
 
 
 
 
the same time. Further communication and 
investigation depend on the countries involved. 

EL  E-mail 
ES 

It is established that the CA of other MS are notified, 
and any information transmitted as for a national 
centre. The procedure stated in Directive 2012/25/EU 
is fulfilled.  

Whenever an organ from a donor in Spain is 
transplanted abroad (EU MS) and a case of vigilance 
might affect this case, the biovigilance team at the 
ONT notifies the case to the corresponding competent 
authority. Updates of the situation as per protocol are 
communicated to the CA of the other MS. The other 
CA is also asked actively for information for a 
comprehensive analysis of the case. The final report is 
transmitted to the CA of the MS transplanting the 
organ.  
FIMEA informs Scandiatransplant which organize all 
organ exchange between Finland, Denmark, Sweden, 
Norway, Iceland, and Estonia. 

FI 

FR  We have no specific procedure regarding vigilance 

information that must be shared with other competent 
authorities. The majority of organs are collected and 
transplanted in France. If needed, we contact directly 
known colleagues in the country concerned. It was the 
case notably during the COVID-19 pandemic crisis. 

A system like RATC/RAB might be a useful tool for 
information sharing between competent authorities 
regarding alert and vigilance events in the field of 
organs. 

HR  Rapid alert from our donor or transplant centres to 

Eurotransplant 

HU  It is always centrally managed by Eurotransplant. All 

initial and final reports are sent to them. 

IE  When an organ has a SARE reported, ODTI reports 
this out to the impacted transplant centres for 
immediate action. When further action is deemed 
necessary it is reported to the relevant competent 
authority in conjunction with the recipient centre. 

42 

Member States is based on the 
information in the initial report. 
E-mail 
According to a national protocol,  

It is established that MS different 
from Portugal should contact and 
inform OCATT and this one 
informs ONT as NCA.   

Portugal must contact directly ONT 
as NCA to exchange information.  

ONT issues the information to the 
regions / hospitals, except 
Catalonia, which is informed by 
OCATT.   

FIMEA receives all SARE reports 
from Scandiatransplant. 

It might be the same informal 
circuit described in the question 10. 

Also, rapid alert from 
Eurotransplant through SARE 
national contact person who 
immediately reports our donor or 
transplant centres  
It is also managed centrally via 
Eurotransplant 
Reverse of 10 above. 

 
 
 
 
 
 
 
 
IT  The list of Competent Authorities for SARE linked to 

organs, available at http://txcontactlist.eu/, 

The contacts of Italian National 
Transplant centre are available at 
http://txcontactlist.eu/ 

allows to alert other CA, that could be affected by a 
SARE within our country. 

LT  Other Member states about related SARE would be 

informed directly by phone and email 

LV  http://www.txcontactlist.eu/index.php?action=details&

id=lv 

RATC/RAB bilateral inquiry. 

NL  SAER alert is sent to Eurotransplant; Eurotransplant 

send the first alert SAER to each transplant centre that 
received an organ 

PL  Phone and/or mail. The list of competent authorities is 

accessible on Poltransplant pages: 
https://ec.europa.eu/health/system/files/2020-
02/competentauthorities_organs_en_0.pdf 
PT  Portugal has an organ exchange agreement with a 
member state (Spain). This agreement follows 
Directive 2012/25/EU of October 9th, 2012, regarding 
information procedures for the exchange of organs 
including the report of serious adverse events and 
reactions. These procedures are also applied to the 
crossover kidney donation under the South Alliance 
for Transplantation (SAT). 
- 

SE 
SI  Notification goes via Eurotransplant, which is in 

charge to inform target country or countries. All next 
steps go as on the national level in all directions and 
with cooperation between responsible clinicians via 
competent authorities and Eurotransplant. 

SK  National transplant organization is responsible for 
contact of other member states if it is the case. 

Other Member states about related 
SARE would inform us directly by 
phone and email 
http://www.txcontactlist.eu/index.p
hp?action=details&id=lv 

RATC/RAB bilateral inquiry. 
see 10 

Phone and/or mail to Poltransplant 
coordinating office working 24/7 

1) Through ONT. 

2) 

- 
The circulation of info goes in the 
same way if Slovenian patients are 
affected, or our country is only in 
the position to transfer info and 
data of the case. Sometimes we 
have just to check our patients if 
the results are ok and at the end, we 
distribute the results. 
The contact place is national 
transplant organization. 
www.nto.sk 

43 

 
 
 
 
 
 
 
 
 
 
 
UK(NI): 

Were there any changes to the reporting 
system for information concerning SARE since 
the last report? 

No 

7.1 Please briefly outline how your 
reporting system works in practice. 
Please explain at what level the system 
is organised (e.g., EOEO, regional, or 
other): 
All incidents must be reported to 
NHSBT who undertake an assisted 
function role on behalf of HTA. NHSBT 
reports any SAE or SAR that meet the 
relevant legislative criteria to HTA. We 
have regular meetings to ensure quality 
and governance of this process. This is 
organised at a national level. 

8. Do you have operating 
procedures in place for the 
notification, in due time, of 
any SARE to the Competent 
Authorities and to the 
concerned procurement 
organisation or 
transplantation centre? 
Yes 

8.1 Do you have 
operating procedures in 
place for the notification, 
in due time, of the 
management measures 
with regards to SARE to 
the Competent 
Authority? 
Yes 

8.2 Please explain how this 
notification system works in 
practice: 

There is a template national 
operating procedure which 
each transplant centre adapts 
to reflect their local practice 
and defines how to report 
incidents to NHSBT. NHSBT 
has standard operating 
procedures of their own which 
set out how they must report 
SAE and SAR to the HTA. 

9. Is an interconnection in place between the 
reporting system for organ transplantation of 
Directive 2010/53/EU and the notification 
system established for the transplantation of 
tissues and cells in accordance with Article 
11(1) of Directive 2004/23/EC? 
Yes 

Please specify how this 
interconnection is organised: 

This detail is set out in the Service Level 
Agreement for example, ensuring the 
HTA reporting system for SAE or SARs 
involving tissues and cells records 
whether a tissue donor was also an organ 
donor. Some HTA staff work across the 
teams looking at SAE & SARs for organ 

44 

 
 
 
 
 
 
transplantation and tissue and cells, so 
there is an ability to link relevant cases. 
10.1 Please describe the procedure for 
you to be contacted by competent 
authorities/delegated bodies from 
other Member State(s) in case of a 
related SARE within the other 
Member State(s) that might affect 
your Member State: 
NHSBT would be contacted by the 
relevant Member State to follow up any 
cases of a related SAEAR within that 
might affect NI. 

10. Please describe the procedure for you to 
contact competent authorities/delegated bodies 
of other Member States in case of a related 
SARE within your country that might affect 
other Member States: 

As part of NHSBT’s assisted function, NHSBT 
will ensure that the information transmitted 
relating to 

the reporting of SAEARs, following the exchange 
of organs between Member States, is carried out 
in 

accordance with Article 4 of the Implementing 
Directive. 

45 

 
 
 
 
4. COVID-19 

Others*  None 

Facilitate 
logistics, 
including 
those 
required 
for cross-
border 
exchange 
of organs 
and travel? 

11. Has your country taken steps to adapt your national procedures for organ donation and 
transplantation in your country in response to COVID-19 and the associated needs? Please select all that 
apply: 
Streamline 
harmonized 
safety and 
quality 
protocols and 
standards 
across 
Member 
States, also to 
allow for the 
cross-border 
exchange of 
organs, based 
on guidance 
such as that 
from ECDC 
on testing 
protocols? 

Support the 
implementati
on of organ 
preservation 
technologies 
that allow 
longer ex-
vivo time 
windows to  
facilitate 
transplants 
when 
logistics are 
more 
complex, 
e.g., in the 
case of local 
outbreaks? 

Implement 
digital 
solutions for 
EU-wide 
data 
collection 
and 
monitoring 
of post-
transplant 
outcomes 
and  
vigilance? 

Strengthen 
common 
research to 
answer 
questions 
on the 
effects of 
communica
ble diseases 
on  
transplantati
on? 

Strengthen 
capacities and 
skills of 
critical care 
professionals, 
donor 
coordinators, 
transplant 
professionals,  
organ 
procurement 
organisations 
and/or 
inter/national 
transplant 
organisations 
to deal with 
these changes  
and 
challenges? 

*Please specify 
which other steps 
you have taken: 

AT 
BE 
BG 
CY 
CZ 
DE 

x 
x 
x 
x 
x 

x 
x 
x 
x 
x 
x 

x 

x 
x 

x 

x 

x 
x 
x 
x 
x 

46 

x 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DK 

x 
x 

EE 
EL 
ES 

x 
x 
x 

x 

x 

x 
x 
x 

x 

x 

47 

x 

x 

The countries in the 
Scandiatransplant 
area were very early 
in the pandemic 
able to test 
thoroughly for 
Covid and take the 
derived issues into 
account. 

Most of the 
transplant activities 
therefore continued 
as usual without 
any greater or 
sustained drop of 
transplant activities. 

ONT has been 
working thoroughly 
on this situation 
from the very 
beginning.  

Transplantation was 
declared to be a 
healthcare priority, 
so donation should 
be prioritized 
whenever possible.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A specific data 
collection was 
launched regarding 
COVID-19 to 
gradually acquire 
knowledge of the 
disease in the area 
of D&T. 

A task group 
composed of 
professionals in 
donation and 
transplantation 
/D&T), and 
infectious diseases, 
was created to 
discuss and 
establish measures 
to prevent / mitigate 
any SARS-COV-2 
transmissions in the 
field of 
transplantation. 
These protocol and 
recommendations 
are updated 
regularly according 
to the bibliography 
and the results.  

A donation 
recovery protocol 

48 

 
 
 
 
was drawn up with 
different phases for 
the gradual 
incorporation of the 
D&T activity. 

A protocol for the 
vaccination of those 
transplanted has 
been developed and 
kept up to date. 

No transmissions of 
SARS-COV-2 have 
been detected so 
far.  

Please note the 
question does not 
match the answers 
(beyond MS). 

Organization of 
webinars for 
patients/transplant 
recipients, setting 
up a platform for 
monitoring 
mortality risk for 

FI 
FR 
HR 
HU 
IE 
IT 

x 

x 
x 

x 

x 
x 

x 

x 

x 
x 

x 

x 

x 

x 

x 
x 

x 

49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
transplant 
recipients, 
periodical update of 
safety protocols 
based on pandemic 
evolution, issuing 
of a national 
protocol for use of 
COVID-19-positive 
donors, indications 
for vaccination of 
immunosuppressed 
patients, 
identification of 
COVID-free 
pathways inside 
hospitals 

Adopting legal 
procedures of 
centres 
accreditation to on-
line forms. 

LT 
LV 
NL 
PL 

PT 
SE 
SI 
SK 

x 
x 
x 
x 

x 

x 
x 

x 
x 

x 
x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 
x 

x 

x 

50 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11.1 Which of those items remain relevant to your country? 

AT  Every information regarding crossing the border and entering the country. 
BE 
BG 

following the ECDC guidelines 
- Facilitate logistics, including those required for cross-border exchange of organs and 
travel, 

- Implement digital solutions for EU-wide data collection and monitoring of post-
transplant outcomes and Vigilance, 

- Implement digital solutions for EU-wide data collection and monitoring of post-
transplant outcomes and Vigilance, 

- Strengthen capacities and skills of critical care professionals, donor coordinators, 
transplant professionals, organ procurement organisations and/or inter/national transplant 
organisations to deal with these changes. 

CY  1,3,5 
CZ  Strengthen capacities and skills of critical care professionals. 
DE  As long as the SARS-CoV-2 pandemic is ongoing, monitoring and if 

necessary/appropriate adaptation of the above indicated aspects remain relevant. 

DK  (See above for this and the following) 
EE  At the moment all the ticked items remain relevant. 
EL  All the mentioned above 
ES  All of them. 
FI 

1. Protocols are based on the first pandemic wave and basically all test positive donors 
were not used for organ tx, as well as recipients positive for covid were not operated 
unless for vital indications. 

FR  None 
HR  safety and quality protocols 
HU  Advanced organ preservation technology: Machine Perfusion 
IE  All of the above 
IT  All of the above 
LT  All previously mentioned 
LV 

In line with the planned collaboration with Scandiatransplant, all our procedures will be 
harmonized according to Scandiatransplant procedures. 

NL  harmonization of criteria, procedures and exchange of best practices 
common rules and practices between Eurotransplant countries 

PL  Streamline harmonized safety and quality protocols and standards across Member States, 
also to allow for the cross-border exchange of organs, based on guidance such as that 
from ECDC on testing protocols? 

PT  1) Definition of national contingency protocols. 

2) All-year professional courses and clinical/technical updates. 

SE  The covid-19 pandemic has not had a negative impact on transplantation frequency in 

Sweden; in 2021 we had a record number of transplantations. 
1,2,3,4,5,6 

SI 

51 

 
 
 
 
 
 
SK  For Slovakia remains a/ implementation for organ preservation technologies, b/ 

strengthen capacities of ICU professionals and donor coordinators, c/strengthen common 
research in transplantation not only the communicable diseases 

11.2 Which challenges have you faced in the context of implementing measures 
responding to COVID-19? 

AT  Lack of collaboration and information exchange with the national crises management. 

Rapidly changing situations and measures. 
BE  making guidelines and protocols regarding covid 
BG 

- Organ shortage. 

- Difficulties in finding solutions for our patients, for which we do not have a transplant 
program. 

CY  Shortage of donors because ICU units were full of Covid 19 patients, difficulties in 

having operation theatres available for surgeries during the pandemic, less hospital beds 
for patients and donors 
CZ  collaboration with laboratories 
DE  The SARS-CoV-2 pandemic is characterized by extreme dynamics both due to the 

changes in the characteristics of the virus (virus variants) and the continuous advances in 
scientific knowledge about the medical aspects (epidemics, clinical manifestation, 
impact on society, donor hospitals, transplant centres, organ donors and transplant 
recipients). Therefore, national, and international (Eurotransplant countries) standing 
working groups had to be established to monitor the most recent developments and to 
adapt policies and procedures where necessary. 
. 

DK 
EE  The international transport logistics has been problematic. Since there are a lot of 

COVID-19 cases, some risk-based decisions must be made. 

EL  Time-consuming transportations, donor/ recipient screenings 
ES  All the former mentioned measures obey to a systematic approach of the problems found 

over time. Still there are others that cannot be forgotten:  

The lack of information at the beginning.  

The fear of transmitting the disease to transplant patients, who are undergoing 
immunosuppression therapy. 

The exhaustion of the personnel of the critical care units. 

The shortage of critical equipment and beds, mostly destined for the COVID patient. 

FI  Lack of proper scientific data at the moment when would have needed that (first 

pandemic wave). 

FR  PCR negative donors, Covid-free hospital circuits. 

In France, an expert group provided recommendations on donor testing in order to avoid 
transmission of COVID to the recipients. These recommendations are taken into account 

52 

 
 
 
 
 
 
 
 
 
 
the nature of the organs (vital versus non vital organs). The main difficulties were the 
territorial location of the laboratories able to test the donors and provide results in due 
time.  

Another difficulty was to adapt quickly in order to take into account the rapid evolving 
scientific knowledge. 

HR  Lack of healthcare workers involved in donor /transplant program because of lack of 

intensivist due to the redistribution of intensive care specialists in COVID departments 

HU  Appointment of responsible SARS-CoV-2 PCR laboratory. 

Additional transport logistics for the samples.  

Additional information collection regarding COVID-19 risk or infection of the deceased.  

IE 

Evaluation and judgment regarding COVID-19 contact potential organ donors.  
- Transplantation infrastructure is not ring fenced in our health service. COVID impacted 
on ICU capacity which directly impacted donation and transplant services 

- Keeping up to date on guidance as it was published and ensuring the system was 1) 
informed 2) had capability to adapt 

IT  Difficulties in managing the pressure on ICUs which suspended in some cases the 
donation activity; inhomogeneous epidemic spread in different regions; setting up 
COVID-free pathways inside hospitals for waitlisted/transplanted patients 

LT  Transplantation of organ after overwhelmed COVID disease when result of PCR test is 

still positive 

LV  Sometimes additional time is needed to repeat Covid19 tests 

Absence of Covid free hospital has significantly deceased transplantation activities 

NL  coordinating the development and continuously adaptation of   national protocols 

tune actions to enable international exchange of organs; synchronisation of definitions, 
criteria, and logistic conditions 
- 

PL 
PT  Adequate in-time application and implementation due to the novelty effect of the 

COVID-19 pandemic, and rapid technical and clinical changes/updates. 

SE  We would welcome more frequent updates of the recommendations for testing and 

SI 

deferral of donors from the ECDC. 
In the period of pandemics, we were facing many different challenges. To keep 
transplant medicine active many meetings between Eurotransplant member countries 
were needed as well constant online contacts on a national level between responsible 
experts. We had to inform all involved people with topical information related to 
preventive measures, related to novelties in connection with a virus, vaccination, 
complications after Covid-19, etc. Patients on the waiting list were very afraid of the 
Covid -19 and even of vaccination. We were trying to collect as much info as it was 
available and relevant. Cross-border organ exchange required balancing between 
different country measures and using a new combination. 

53 

 
 
 
 
 
 
 
 
SK  The problems arise from capacities of health care system (ICU capacities considerable 
influenced the donor program). Organization of health care for transplant patients, 
especially with COVID-19 at transplant centres. 

12. Which aspect(s) do you think should be prioritised to ensure that detrimental 
effects of COVID-19 in the organ sector are mitigated and the sector is 
strengthened in the long term? 

AT  Raising awareness of decision-makers, that organ donation and transplantation is a life 

saving measure. 

Development and maintenance of an information network with cross border partners. 

BE  EU related guidelines and protocols 
BG 

- Streamline harmonized safety and quality protocols and standards across Member 
States, also to allow for the cross-border exchange of organs, based on guidance such as 
that from ECDC on testing protocols, 

- Facilitate logistics, including those required for cross-border exchange of organs and 
travel, 

- Support the implementation of organ preservation technologies that allow longer ex-
vivo time windows to facilitate transplants when logistics are more complex, e.g., in the 
case of local outbreaks, 

- Implement digital solutions for EU-wide data collection and monitoring of post-
transplant outcomes and Vigilance, 

- Strengthen capacities and skills of critical care professionals, donor coordinators, 
transplant professionals, organ procurement organisations and/or inter/national transplant 
organisations to deal with these changes and challenges. 

CY  Developing safety protocols in order to assure that transplant activity will not be 

decreased again in case of a new pandemic wave 
CZ  close cooperation with regional transplant centres 
DE  The SARS-CoV-2 pandemic had direct and indirect effects on organ donation and 

transplantation. Direct effects are linked to the medical risk related to the disease for 
transplant recipients and the medical staff (nurses and doctors) involved in donor 
management, organ procurement and transplantation. 

International scientific cooperation including comprehensive data collection and 
exchange would help to speed up developing evidence-based approaches to this and 
potential future pandemics. Many recommendations in this field were and are still based 
on expert opinion, scattered small case series etc. Indirect effects derive a) from the 
availability of resources (perfusion fluids, medical devices (testing)). Another indirect 
effect of the pandemic was the extreme burden for the health care personal. 
. 

DK 

54 

 
 
 
 
 
 
 
 
 
 
EE  Problems in international organ exchange and logistics should be addressed. An updated 

guide from ECDC would be very helpful. 

EL  Procedures’ harmonisation / digital harmonisation 
ES  More resources.  

Rapid recommendations and a space to share them with the NCA and allow them to put 
national recommendations in common for comments or suggestions. 

FI  Cooperation of experts - common recommendations 
FR  N/A 
HR  Contingency plans need to be drawn up and Sops implemented in practice 
HU  Studies that exclude or prove organ specific SARS-CoV-2 transmission to maximise 

organ transplantation maintaining quality and safety. 
- Streamlined protocols across member state jurisdiction 

IE 

-Strengthen capacity and capability of donation and transplantation personnel and 
organisations to deal with necessary changes and challenges 

- support for ring fencing of donation and transplantation services in member states. 

IT  Need to establish emergency plan to cope with possible epidemic; need to increase the 

number of ICU-dedicated staff and ICU beds; widespread implementation of 
telemedicine tools to ensure remote follow-up of patients 

LT  European recommendations 
LV  Common strategies and practices in EU MS regarding COVID19 positive donors, HCV 

positive donors and similar situations in donation and transplantation. 

NL  availability of ICU beds, for patients and potential donors, vaccines for both professional 

and patients and materials to protect professionals 
- 

PL 
PT  Broaden allocation criteria for solid organs, based upon scientific evidence, 

Professional on-going educative courses. 

SE  Difficult to say, as we did not experience a dip in transplantations. 
SI  Topical information and constant refreshing of knowledge to keep HCP motivated and 

dedicated to work. 

SK  The priority in our country is strengthening the capacities of critical care professionals 
and ICU. The second is additional hospitalization capacity for COVID-19 transplanted 
patients at transplant centres. 

12.1 Which aspects do you think would benefit from further EU coordination? 
Implementation of EU-wide recommendations from EU experts, e.g., from ECDC. 
AT 
BE  Registration of weak positive donors, recover covid donors, follow-up of recipients who 

received organs of recovered donors with covid... 

BG  Organ exchange 
CY  Usage of grafts from Covid 19 positive patients based on experience from some EU 

countries, facilitating logistics within EU 

CZ  No opinion 

55 

 
 
 
 
 
 
 
 
DE  S. 12. Indirect effects of the pandemic derive from the availability of resources 

(perfusion fluids, medical devices (testing)). Many of these products come from outside 
the EU, it might be advisable for the EU to be more self-sufficient in this area. Another 
indirect effect of the pandemic was the extreme burden for the health care personal. 
European Strategies to address the challenges in this area should be considered. 
. 

DK 
EE  Updated and harmonised guidelines would be useful. Common EU risk analysis on 

utilisation of COVID-19-positive donors and COVID-19 positive recipient management 
would be appreciated. 

EL  Exchange experience and knowledge 
ES 
FI 

Increasing the donor pool for those with difficulties in reaching an organ. 
Strengthen role of ECDC? 

Strengthen common research to answer questions on the effects of communicable 
diseases on transplantation? 

FR  Harmonization of donor testing measures 
HR 

In order how to respond to a critical situation, to avoid or minimize damage and to 
provide direction on staffing, resources and communication, the help of further EU 
coordination and support in this time of crises (contingency plan) is more than 
welcomed. 

HU  Sharing real-time the changes in national organ donation protocols regarding COVID-

IE 

19, preferably in English. 
- Member state rapid response forum as a resource to inform on updates to guidance as 
they happen, 

- Streamlined protocols across member state jurisdiction, 

IT 

- support for ring fencing of donation and transplantation services in member states. 
Strengthen common research to answer questions on the effects of communicable 
diseases on transplantation 

LT  European recommendations of donation and transplantation with past or active COVID-

19 

- 

LV  all aspects, mentioned in Q11 
NL  synchronization of measurement, same conditions for cross border exchange 
PL 
PT  Big-data platforms can improve scientific knowledge,(cid:13)Harmonization and 
standardization of some procedures and/or criteria,(cid:13)Improve donation and 
transplantation efficacy due to allowing access to a much larger number of individuals. 

SE  Recommendations and guidelines for testing and deferral of donors. 
SI 

Financial support of education, presenting of good clinical practices, composing working 
groups to collect topical info and news, building on on-line EU office with relevant 
experts on call 24/7 or at least during the day to help different experts in conflicting 
situations 

SK  The recommendations and guidelines are a great help in management of procurement 

and transplantation. 

56 

 
 
 
 
 
UK(NI): 

*Please 
specify 
which 
other 
steps you 
have 
taken: 

Others*  None 

Facilitate 
logistics, 
including 
those 
required 
for cross-
border 
exchange 
of organs 
and 
travel? 

Implement 
digital 
solutions 
for EU-
wide data 
collection 
and 
monitorin
g of post-
transplant 
outcomes 
and  
vigilance? 

Strengthen 
common 
research to 
answer 
questions on the 
effects of 
communicable 
diseases on  
transplantation? 

Strengthen 
capacities and 
skills of critical 
care professionals, 
donor coordinators, 
transplant 
professionals,  
organ procurement 
organisations 
and/or 
inter/national 
transplant 
organisations to 
deal with these 
changes  
and challenges? 

11. Has your country taken steps to adapt your national procedures for organ donation and transplantation in 
your country in response to COVID-19 and the associated needs? Please select all that apply: 
Support the 
Streamline 
implementation 
harmonized 
of organ 
safety and 
preservation 
quality 
technologies 
protocols and 
that allow 
standards 
longer ex-vivo 
across Member 
time windows 
States, also to 
to  
allow for the 
facilitate 
cross-border 
transplants 
exchange of 
when logistics 
organs, based 
are more 
on guidance 
complex, e.g., 
such as that 
in the case of 
from ECDC on 
local 
testing 
outbreaks? 
protocols? 
x 
x 
x 
11.1 Which of those items remain relevant to your country? 
Sharing of policies and procedures / any changes to practice amongst Member States and being able to share deceased donor and 
transplant related data across Member States. 
11.2 Which challenges have you faced in the context of implementing measures responding to COVID-19? 
Capacity of critical care units, transplant units and access to ICU beds to care for recipients have been a challenge. This has been 
due to periods of high critical care bed occupancy from COVID-19+ve patients over winter January 2021 but more latterly an 
impact of NHS staffing within winter December - January 2022. 
We have good, clear communication pathways externally within NHSBT from the Clinical Team, Chairs of Advisory groups and 
recipient coordinators enabling implementation of any changes. 
12.1 Which aspects do you think would benefit from further EU coordination? 
Continued clarity of Member States testing for SARS-CoV-2 upper / lower respiratory tract samples for example if centre in NI 
accept an organ, are they clear on what tests have been undertaken? 

x 

x 

x 

57 

 
 
 
 
 
 
Please describe your difficulties: 

5. Open Comments 

13. Have you 
encountered any 
difficulties when 
implementing the 
requirements in 
accordance with 
Directive 
2010/53/EU? 

AT  Yes 

BE  No 
BG  No 
CY  No 
CZ  No 
DE  No 
DK  No 
EE  No 
EL  No 
ES  No 
FI  No 
FR  No 

HR  No 
HU  No 
IE  Yes 

IT  No 
LT  No 
LV  No 
NL  No 
PL  No 
PT  No 
SE  No 
SI  No 
SK  No 

Because of the federal structure of Austria various of 
disseminated stakeholders are involved and the coordination is 
complex. 

This was a large undertaking at National level as it required 
collaboration and consolidation of a number of sectors in order 
ensure continuity of services. As the quality framework and 
regulations were being introduced to the area for the first time. 
Introducing regulators and QMS was challenging and led to an 
extensive learning phase. This is only now maturing to allow 
move to next level. QMS focus needs to focus on continuous 
improvement and International Council for Harmonisation Q10 
focus as opposed to traditional quality model.   

58 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please describe your difficulties: 

14. Have you 
encountered any 
difficulties when 
interpreting the 
requirements in 
accordance with 
Directive 
2010/53/EU? 

AT  Yes 

BE  No 
BG  No 
CY  No 
CZ  No 
DE  No 
DK  No 
EE  No 
EL  Yes 
ES  No 
FI  No 
FR  No 
HR  No 
HU  No 
IE  No 
IT  No 
LT  No 
LV  No 
NL  No 
PL  No 
PT  No 
SE  No 
SI  Yes 

SK  No 

There should be clear and legally written definitions, e.g., 
supervision. 

Actually not. We tried to meet all requirements and principles 
in line we our capacities and availability of facilities and HCP.  
Very helpful was a fact that we succeeded in putting in place 
already in 2002 the competent authority with many tasks 
defined later in the directive 53/2010. All those tasks were 
defined in our transplant law from 2020. 

59 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please specify in which respect or on which aspects: 

15. The Directive 
does not prevent any 
Member States from 
maintaining or 
introducing more 
stringent rules. Has 
your Member State 
maintained or 
introduced more 
stringent rules? 

AT  No 
BE  No 
BG  No 
CY  No 
CZ  No 
DE  No 
DK  No 
EE  No 
EL  Yes 
ES  No 
FI  No 
FR  No 
HR  No 
HU  Yes 

IE  No 
IT  No 
LT  No 
LV  No 
NL  No 
PL  No 
PT  No 
SE  No 
SI  No 
SK  No 

Hungary annually evaluates the national organ donation and 
transplantation programme, which is publicly available as 
Annual Reports.  

The national organ donation registry collects data about all 
discarded organs (via pathology reports), and quality reports of 
the organs at procurement and transplantation phase, and 
Hungary has hospital level quality assurance programme for 
organ donation 

60 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please specify which aspects: 

16. Are there aspects 
of the revision of the 
framework for 
Blood, Tissues, and 
Cells that you find 
relevant to the organ 
sector? 

AT  No 
BE  No 
BG  No 
CY  No 
CZ  No 
DE  No 
DK  Yes 

EE  Yes 

EL  No 
ES  Yes 

FI  Yes 

FR  Yes 

HR  Yes 

HU  No 
IE  Yes 

Deceased organ donors are occasionally also tissue donors. A 
clearer link between the T&C and organ legislation e.g., with 
respect to SAREs would be welcome. 
It is difficult to say since the adoption of the revision has not 
been completed, but it is stated in Directive 2010/53/EU that 
quality and safety requirements for organs should complement 
and be linked with the existing Union system for tissues and 
cells, so revision of Blood, Tissues, and Cells directives can 
have an impact to organ regulation. 

As said before,  

- donor protection for other purposes other than transplantation. 

- profit and affordability of the health care systems (costs for 
the healthcare system from new therapies, or costs derived from 
new requisites, e.g., transport containers with a limited number 
of uses) 
Should the infection test requirements be the same (serological 
tests and PCR tests for HIV, HBV and HCV) for all allogenic 
donors? 
Harmonization of preventive measures for the transmission of 
pathogens would be good.  The role of ECDC might be 
reinforced in that perspective. 
living donor protection and follow up, especially in light of 
commercialisation and growing demand, biovigilance, 
traceability etc. 

The involvement of European Expert Bodies to draft 
guidelines, share knowledge would be of benefit. This could 
lead to resources being available for training programmes 
provided to key personnel and teams. Stakeholder meetings and 

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
IT  No 
LT  No 
LV  Yes 
NL  Yes 
PL  No 
PT  No 
SE  No 
SI  Yes 

SK  No 

workshops to build channels for communication and for 
gathering information etc. 

No commercialisation of SoHO field. 
concerning 16: is already put forward, but not published yet 

I think that revision shouldn't go in the way that all three 
segments would be completely separated. There are the same 
principles that should be covered by the legislation for organs, 
tissues and cells and to some extent even for blood as donation 
principles and promotion activities of altruistic donation. 
Transparency, traceability, quality and safety of organs, tissue 
and cells require absolutely the same principles and should be 
covered by one legislation, and this is of immense importance 
for development in the future. 

If the field of tissues and cells will be joint only with the blood 
issues and will be distanced from organs, commercialization of 
the field might come on the scene and donation of human body 
parts for the purpose of treatment will become a subject of 
processing and profit-making matters. Why? The substrate for 
processing will be interpreted as a technical issue and not as 
part of a human being which requires strong focus on dignity 
and taking care of human rights more than just for technical 
substrates. 

Do you have any other comment not covered in the previous questions? 

AT 
BE 
BG 
CY 
CZ 
DE 
DK  Regarding 2.2: Does your country exchange organs with third countries? 

There has previously existed occasional collaboration with Great Britain. How this will 
proceed is currently unknown. 

Regarding: 2.1 Does your country exchange organs with other EU Member States? 

62 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Yes - Norway on regular basis and Schweitz on rare occasions. 

However - both countries have collaboration agreements with the EU 

Scandiatransplant is a collaboration between transplant centres in Denmark, Sweden, 
Norway, Finland, Iceland, and Estonia - for exchange of organs. Scandiatransplant host 
an IT-system which include a dedicated IT-tool. This system is hosted and managed by 
Scandiatransplant (in Aarhus, Denmark). 

The core Scandiatransplant transplantation registry was established January 1995. Basic 
data on all living donors from this date and forward are found in the Scandiatransplant 
living donor. 

For further information see: www.scandiatransplant.org 
- 

EE 
EL 
ES  Thank you for your attention. Kind regards. 
FI 
FR  The BTC directive appears to implement decisions that would reinforce the role of 
ECDC, which should allow for a better harmonisation of biological qualification of 
donors. A harmonised organ qualification approach would also encourage exchange 
among the EU countries, especially taken into account that organ donors might as well 
be cell and/or tissue donors. 

- 

HR 
HU 
IE  Nil 
IT 
LT 
LV 
NL 
PL 
PT  NA 
SE  Please note that I put in the answer "no" as default on every question in section 3. This is 
not the true answers, but I have no other answers to give, as these questions are under the 
responsibility of another authority, and they do not have the possibility to participate in 
this survey. 
I hope that the suggestions given found out of this survey and of other discussions will 
be taken into account for the future steps related to preparing of refreshed EU legislation. 
We all, who are working at the moment in the field of using human body parts for the 
purpose of treatment and research are responsible for future progress. 

SI 

 We all are obliged to create the basis for our offsprings which should keep human body 
parts as very special drug donated for people in a very bad condition with the intention to 
help them and create positive atmosphere on our planet. 

SK 

63 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UK(NI): 

13. Have you encountered any difficulties 
when implementing the requirements in 
accordance with Directive 2010/53/EU? 
No 
14. Have you encountered any difficulties 
when interpreting the requirements in 
accordance with Directive 2010/53/EU? 
No 
15. The Directive does not prevent any 
Member States from maintaining or 
introducing more stringent rules. Has 
your Member State maintained or 
introduced more stringent rules? 
No 
16. Are there aspects of the revision of the 
framework for Blood, Tissues, and Cells 
that you find relevant to the organ sector? 
Yes 

Please describe your difficulties: 

Please describe your difficulties: 

Please specify in which respect or on which 
aspects: 

Please specify which aspects: 

Based on our understanding of the proposals 
being considered, some of these would also be 
relevant to the organs sector. For example, 
unequal approaches to oversight across EU 
Member States leading to barriers to exchange, 
legislation that lags behind innovation, supply 
vulnerabilities and the evaluation and clinical 
efficacy of novel products (in the organs sector 
this could be relevant to novel organ 
transplants). We would value an opportunity to 
review early any changes that may be 
considered to impact on the organs sector. 

Do you have any other comment not covered in the previous questions? 
For ease and clarity, we are submitting one joint country response from HTA and NHSBT, 
applicable to NI for 2015-2021. 

64