Biomedical and Clinical Engineering Education, Accreditation, Training and Certification    

Medical/Biological/Clinical Engineering Providing a Safe Health Care Environment      

Career Development
Study Guide
CE Regulation
3rd Conference
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Though harmonising the European education systems and making European education policies more dynamic are high on the list of European political priorities, there are strict regulations and limitations on what is possible and who can decide which way to go within the EU. The 1997 Amsterdam treaty clarifies which activities of the European Commission in the area of education are allowed in cooperation with the member countries in order to reach the common goal of high quality educational systems in all regions of the EU. The treaty emphasizes the European dimension of education, but nevertheless insists on subsidiary, clearly limiting the power of the Union, and leaving full and unrestricted responsibility for the structuring of educational systems as well as for curricula with the individual member state. The responsibility of the Union is to support and supplement activities of the member states in the area of education. The treaty does, explicitly, not allow harmonisation of national laws and administrative procedures by unilateral decisions of any European entities.

Thus, implementation of the European Higher Education Area cannot be decided or dictated by the European Commission, it can only be achieved by European bodies that include all member states and that are able to reach unanimous decisions. Therefore, the Bologna process, i.e. the realisation of the European Higher Education Area through the consensus of all 40 Bologna signatory states, is very important and needs to be fully supported by the MBES community.

For this purpose, a Europe-wide participation project, BIOMEDEA, has been launched in 2004 by Joachim Nagel in cooperation with Dick Slaaf and Jan Wojcicki as well as colleagues from 32 European countries, aiming at contributing to the realisation of the European Higher Education Area in MBES. The project coordinates previously started initiatives, using the available synergies to facilitate the implementation of the European Higher Education Area in the field of Medical and Biological Engineering and Sciences for the benefit of the universities, the students and last but not least the European people.

The project aims at establishing Europe-wide consensus on guidelines for the harmonisation of high quality MBES programs, their accreditation and for the certification or even registration and continuing education of professionals working in the health care systems. Improved quality assurance of MBES education and training is a vital component and is also directly related to the issues of health care quality. It offers the advantages of providing confidence for the employer that the employee has the necessary education, training and responsible experience, and the reassurance for the user of the service, meaning the patients, that those providing the service are effective and competent. Adherence to these guidelines will insure mobility in education and employment, and improved competitiveness of the European biomedical industries.

Thinking about how to realise the requests for employability, mobility, compatibility, and quality assurance, it becomes obvious that the most urgent issues in this context are to harmonise and to generate agreement on the recognition and transparency of qualifications, specifically accreditation of educational programs, training, continuing education, certification of individuals and a regulation of safety-critical professions.


Achievements, Trends and Developments

Several studies have been published on the recent changes in the European national educational systems in general which indicate mostly positive influences on the quality of education. Information on the post Bologna developments of education, training and accreditation in the area of Biomedical Engineering has been gathered in the IFMBE White Paper on the status of MBES in Europe, organised and edited by Joachim Nagel. Information has been obtained about the situation and practice in 28 European countries and contains an overview, written by Joe Barbenel (University of Strathclyde, Glasgow, UK), attempting to compare and contrast the different national models. When looking at all the information it is necessary to bear in mind two important constraints. The field of Biomedical Engineering is changing and growing rapidly, which means that some of the information was out of date almost as soon as it was written. The sections on different countries also show the enormous national variability in both educational practice and nomenclature that makes comparison difficult. It is to be hoped that the implementation of the ideas and aims of the Bologna Declaration will lead to more consistency and simplicity in the future.

BIOMEDEA, the European participation project preparing Medical and Biological Engineering and Sciences for EHEA, is moving ahead very successfully with its goal to harmonise MBES education and training in Europe. The first two meetings that took place in Eindhoven (2004,, and in Warsaw (2005, dealt with Biomedical Engineering (BME) curricula, the training of clinical engineers, and the accreditation of BME programs in Europe.

The Eindhoven meeting consisted of 4 workshops:

  1. The Undergraduate Biomedical Engineering Curriculum, with the goals to delineate the core topics in biomedical engineering science that all BME students should understand, the biomedical engineering science topics, underpinning areas of BME specialization, and the critical skills expected of all undergraduate biomedical engineers.

  2. The Biomedical Engineering Master Curriculum. The goals were to delineate at the graduate level intellectual underpinnings for the future of biomedical engineering, integration of the engineering sciences and modern biology, engineering opportunities in the hospital, and critical skills.

  3. Educational methods and best practices. The goals of the workshop were to discuss educational methods and to illustrate best practices adapted to teaching biomedical engineers how to solve clinical and biological problems.

  4. Training. The goal of this part of BIOMEDEA was to gather the information necessary to write a survey on BME/CE Training in Europe and to establish guidelines for the minimum requirements for the training of Clinical Engineers in Europe.

The Warsaw meeting included workshops on:

  1. Guidelines for the accreditation of BME Programs in Europe: why do we need them and what should they specify? The goal of the workshop was to specify the general requirements of the guidelines.

  2. BME/CE training – a European training scheme, with the goal to establish a European Protocol for the formation and training of biomedical or clinical engineers working in a hospital environment.

  3. BME core competencies and specialisations that should be recommended in the guidelines for the accreditation of BME programs in Europe.

  4. Guidelines for curricula, specifying a flexible framework of BME curricula as a guide for the accreditation of BME programs.

  5. Basic competencies in engineering/science, biology and medicine and general competencies including “soft skills” as minimum output requirements for accredited BME programs.

The next BIOMEDEA meeting, to take place in Stuttgart in September, 2005, will be organised in cooperation with the World Health Organization (WHO) and mainly be dedicated to the development of a European scheme for the certification and continuing education of clinical engineers. The meeting will also, in cooperation with the responsible bodies in other parts of the world, establish international cooperation with the goal to achieve global harmonisation on the education and certification of biomedical/clinical engineers. 

The expected results of BIOMEDEA will be a white paper on BME education, educational methods and best practices in Europe, protocols for the formation, training, certification and continuing education of clinical engineers in Europe, and guidelines for the accreditation of BME programs in Europe. The International Federation for Medical and Biological Engineering (IFMBE), the main sponsor of BIOMEDEA, will, in cooperation with WHO, as a part of the initiatives of the World Alliance for Patient Safety, set up a global registry of certified clinical engineers with the goal of international mutual recognition of certification, and strive towards making certification and/or registration of clinical engineers mandatory everywhere in the world, based on the same criteria.

Primary goal of BIOMEDEA remains, however, to prepare the BME European Higher Education Area and to find recognition by the national governments throughout Europe, the European Union and the European bodies that are the main players in engineering education and accreditation.

A new project with broad support from the European bodies entrusted by the Bologna countries with the task of establishing European standards and procedures for quality assurance and accreditation in higher education, EUR-ACE (Accreditation of European Engineering Programs and Graduates) aims at setting up a European system for accreditation of Engineering education [8] with the following main aims: provide an appropriate “European label” to the graduates of the accredited educational programs, improve the quality of educational programs in engineering, facilitate trans-national recognition by the label marking, facilitate recognition by the competent authorities in accord with the EU Directives and facilitate mutual recognition agreements. The system will be based on a set of common European standards that will be proposed, tested in a number of countries, refined and tuned, and then tested again in order to achieve the largest consensus. A detailed proposal will also be formulated on how to set up and run the system that must become self-supporting within five years. The project will thus interest several target groups, from higher education decision-makers at the European level to governing bodies of Higher Education (HE) Institutions, from national and local HE authorities to engineering teachers, from professional organisations to employers of engineers. It will be a significant contribution to the harmonisation of European higher education, and possibly pave the way for analogous initiatives in other professional fields.

BIOMEDEA, and thus the European BME community, has been accepted to represent the specific biomedical engineering issues and interests within EUR-ACE, and to test its specific criteria for accreditation within the project. For the BME community this is a major step forward towards the establishment of EHEA under due consideration of the specific needs of Medical and Biological Engineering and Sciences.



The evolving European Higher Education Area will substantially influence the development of medical and biological engineering and sciences. These developments will be beneficial to the biomedical engineering profession and to society as a whole. The biomedical engineering community must grasp this opportunity through focused national and European actions and cooperation with the relevant bodies.


Last update: Nov-08