Medical Implants [EU]
Standards of quality and safety of organs intended for transplantation
The therapeutic use of organs poses certain risks which should be limited by a judicial framework covering all stages of the process from donation to transplantation. The safety and quality of organs should be guaranteed, as should the protection of donors and recipients through the competent authorities.
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.
Summary
This Directive sets out a common framework on quality and safety standards for organs * of human origin intended for transplantation into the human body. It also aims to protect donors * and optimise exchanges between Member States and third countries.
Scope
This Directive covers only those organs to be transplanted into the human body, and not the use of organs for the purposes of research.
It applies to:
It does not apply to:
- blood;
- blood components;
- human tissues and cells;
- organs, tissues and cells of animal origin.
Quality and safety of organs
Member States shall implement a quality and safety framework which defines the parameters of all stages of the chain from donation to transplantation *.
These quality and safety frameworks are to fix all of the parameters of the process continuously, from donation to transplantation. They have the following functions in particular:
- to define traceability * procedures from donation to transplantation or disposal of the organ;
- to implement standard operating procedures *;
- to establish the qualifications of personnel.
The procurement of an organ (that has previously been subject to a characterisation) is to be performed in dedicated facilities and under the supervision of a medical doctor as defined in Directive 2005/36/EC.
All procured organs must be characterised before transplantation. The minimum information required includes:
- le type of donor;
- the blood group;
- the cause and date of death of the donor;
- the clinical history of the donor, including aspects such as neoplasia, hepatisis, HIV or IV drug abuse.
Other complimentary information may be requested, such as the medical history of the donor or, for example, physical and clinical data.
The transport of organs shall be carried out according to clearly defined criteria. The shipping containers used by organisations or companies must contain information such as contact details for the procurement and transplantation organisations, be marked ‘handle with care’ and contain safety instructions and method of cooling.
All organs procured, allocated and transplanted on the territory must be traceable from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients.
If a serious adverse event should occur following organ transplantation, a reporting system, put in place by Member States, should allow relevant information to be reported and transmitted.
Donor and recipient protection
Organ donation must be voluntary and unpaid. However, compensation may be granted to make good the expenses and loss of income related to the donation, while avoiding any financial incentive.
Member States shall be prohibited from advertising the need for, or availability of, organs.
Living donors are to be provided with comprehensive information as to the purpose and nature of the donation, and the consequences and risks involved.
Qualified medical personnel are to select donors on the basis of their health and medical history including a psychological evaluation. These provisions guarantee the quality and safety of organs.
The personal data of the donor shall be protected in line with Directive 95/46/EC. Anonymity is guaranteed.
Competent authorities
Member States shall designate the competent authorities to implement the Directive. They will, in particular, supervise the implementation of the quality and safety framework and exchanges with Member States or third countries;
Context
Over the last 20 years, the use of human organs for transplantation has increased considerably. This technique makes it possible to compensate for the failure of organs such as the liver, lungs or heart. However, this medical practice is associated with risks which this Directive aims to reduce by introducing strict standards concerning the quality and safety of organs.
| Key terms used in the act |
| ·        Organ: a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy;
·        Donor: every human source of organs, whether living or deceased; ·        Donation: donating human organs for transplantation; ·        Transplantation: the process of restoring certain functions of the human body by transferring equivalent organs to a recipient; ·        Traceability: the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, this authority, under specified circumstances set out in this Directive being authorised to: identify the donor and the procurement organisation, identify the recipient(s) at the transplantation centre(s), locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ; ·        Standard operating procedures: written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product; ·        Procurement: a process by which the donated organs become available; ·        Donor characterisation: the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation. |
References
| Act | Entry into force | Deadline for transposition in the Member States | Official Journal |
| Directive 2010/53/EU | 26.8.2010 | 27.8.2012 | OJ L 207 of 6.8.2010 |
In vitro diagnostic medical devices
This directive aims to ensure the free movement of in vitro diagnostic devices. It harmonises the national laws on the reliability of these products and on the protection of the health and safety of patients, users and third parties.
ACT
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on
In vitro diagnostic medical devices
The Directive applies to in vitro diagnostic medical devices and their accessories.
These devices are products used for the in vitro analysis of tissues or substances (blood, specimens) from the human body. The types of analysis covered are as follows:
- state of health;
- congenital diseases or anomalies;
- checking the progress of courses of treatment;
- determining compatibility in the case of organ or blood donations.
The Directive lays down the objectives or “essential requirements” of safety, health, design and manufacture which must be met by in vitro diagnostic medical devices when they are manufactured and placed on the market.
Harmonised European standards on the prevention of risks relating to the design, manufacture and packaging of products are drawn up by the European standards bodies on the basis of the essential requirements. These standards, which are not mandatory, are published in the Official Journal of the European Union in the form of national standards with identical contents.
Any product manufactured in accordance with harmonised standards is presumed to conform to the essential requirements.
The product conformity assessment procedures and the essential requirements are based on the modular approach set out in Council Decision 93/465/EEC on the CE conformity marking. Conformity assessment is the responsibility of:
- manufacturers or their authorised representatives themselves; or
- more rarely, bodies which may be designated by the Member States in accordance with joint evaluation criteria and notified to the Commission and the other Member States.
Before they can be placed on the market, devices must bear the CE marking of conformity which:
- confirms that they conform to the provisions of this Directive;
- consists of a single graduated drawing the “CE” mark, accompanied by the identification number of the notified body responsible for following the procedures;
- is affixed by the manufacturer or his authorised representative established in the Community.
If a device is subject to other Directives which require “CE” marking, the affixing of the mark also indicates that the device conforms to the requirements of those Directives.
Any other mark may also be affixed to the devices provided there is no risk of it being confused with the conformity mark.
Penalties can be imposed by the Member States if they find that the mark has been unduly affixed.
A safety clause allows any Member State, in an emergency, to withdraw the devices, when correctly installed, maintained and used for their intended purpose, from the market if they may compromise the safety of property and the health and/or safety of users or third parties.
Administrative cooperation and the exchange of information between the Member States are necessary to guarantee conformity with this Directive.
Any fault (malfunction, inadequate labelling, etc.) which is connected with the use of a device bearing the CE marking and which has caused serious risks to the health of a user or led to the recall of devices of the same type must be recorded and evaluated centrally.
A European databank, accessible to the competent authorities of the Member States, will contain all the regulatory data relating to implementation of the Directive (registration of manufacturers and devices, certificates issued, etc.).
The Directive defines transitional periods of five and seven years during which the Member States may authorise the placing on the market and the putting into service respectively of devices conforming to the rules in force in their territory on the date of adoption of the Directive.
References
| Act | Entry into force | Deadline for transposition in the Member States | Official Journal |
| Directive 98/79/EC | 07.12.1998 | 07.12.1998 | OJ L 331 of 07.12.1998 |
| Amending act(s) | Entry into force | Deadline for transposition in the Member States | Official Journal |
| Regulation (EC) No 1882/2003 | 20.11.2003 | – | OJ L 284 of 31.10.2003 |
RELATED ACTS
Harmonised standards:
Commission Communications in the framework of the implementation Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
Official Journal C 227 of 10.08.1999;
Official Journal C 288 of 09.10.1999;
Official Journal C 293 of 14.10.2000;
Official Journal C 319 of 14.11.2001;
Official Journal C 182 of 31.07.2002;
Official Journal C 314 of 17.12.2002;
Official Journal C 32 of 11.02.2003;
Official Journal C 280 of 21.11.2003;
Official Journal C 83 of 02.04.2004.
These Commission Communications contain the list of titles and references of European standards under the Directive.
List of titles and references of harmonised standards
Notified bodies
The NANDO-IS database will enable you to find the European notified bodies as well as third country bodies which are responsible for carrying out the conformity assessment procedures referred to in the New Approach directives.
Common technical specifications:
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices [Official Journal L 131 of 16.05.2002].
This Decision sets out common technical specifications to replace the former specific provisions in the Member States, which mainly concerned devices used for evaluating the safety of blood supply and of organ donation. The technical specifications in this Decision relate to medical devices used for determining blood groups or for detecting and confirming HIV infection or hepatitis, amongst others.