Regulations and Directives—Past, Present, Future

  • Haris MemićEmail author
  • Almir Badnjević
  • Zijad Džemić
Part of the Series in Biomedical Engineering book series (BIOMENG)


Regulations are binding acts which are obligatory in the European Union. All members of the European Union must apply Regulations. On the other hand, there are Directives, legislative acts which represent the base setting the goal which has to be achieved by EU countries for a specific area. Each EU country has individual national laws in order to achieve that goal. Directives which regulate harmonized products in the EU are known as New Approach Directives. One of the Directives which belong to the group of the New Approach is Directive 93/42/EEC on medical devices. The integral part of a Directive is Harmonised Standard which serves Manufacturers, other economic operators, or conformity assessment bodies to demonstrate that products, services, or processes comply with relevant EU legislation. Conformity assessment is a process that is performed by the manufacturer in order to demonstrate if all specific requirements related to the product have been met. Conformity assessment is provided by a competent body (notified bodies) and differs for different classification of medical devices. There are different approaches in conformity assessment of medical devices in the EU and USA which are described in this chapter. Many European countries have recognised the importance of metrology and its influence in providing services which will ensure accurate and precise measurements of medical devices that have a measurement function.


  1. 1.
  2. 2.
  3. 3.
  4. 4.
  5. 5.
    The European Committee for StandardizationGoogle Scholar
  6. 6.
    The European Committee for Electrotechnical StandardizationGoogle Scholar
  7. 7.
    The European Telecommunications Standards InstituteGoogle Scholar
  8. 8.
    Council Directive 93/42/EECGoogle Scholar
  9. 9.
    Approval of Medical Devices, The Law Library of Congress, Global Legal Research CenterGoogle Scholar
  10. 10.
  11. 11.
  12. 12.
  13. 13.
  14. 14.
  15. 15.
  16. 16.
    Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices ‘designating authority’ means the authority(ies) entrusted by a Member State to assess, designate, notify and monitor notified bodies under Directive 90/385/EEC or Directive 93/42/EECGoogle Scholar
  17. 17.
  18. 18.
  19. 19.
  20. 20.
    Stinshoff KE Role of standards in the assessment of medical devices.
  21. 21.
  22. 22.
  23. 23.
    Council Directive of December 20, 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EECGoogle Scholar
  24. 24.
    Directive 2014/32/EU of The European Parliament and of The Council of February 26, 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instrumentsGoogle Scholar
  25. 25.
    Directive 2014/31/EU of The European Parliament and of The Council of February 26, 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instrumentsGoogle Scholar
  26. 26.
    OIML D 1 Considerations for a Law on MetrologyGoogle Scholar
  27. 27.
  28. 28.
    International vocabulary of terms in legal metrology (VIML)Google Scholar
  29. 29.
    Badnjevic A, Gurbeta L, Jimenez ER, Iadanza E (2017) Testing of mechanical ventilators and infant incubators in healthcare institutions. Technol Health Care J 25:237Google Scholar
  30. 30.
    Gurbeta L, Badnjevic A, Dzemic Z, Jimenez ER, Jakupovic A (2016) Testing of therapeutic ultrasound in healthcare institutions. In: Bosnia and Herzegovina, 2nd EAI international conference on future access enablers of ubiquitous and intelligent infrastructures, 24–25 October 2016, Belgrade, SerbiaGoogle Scholar
  31. 31.
    Gurbeta L, Badnjevic A, Pinjo N, Ljumic F (2015) Software package for tracking status of inspection dates and reports of medical devices in healthcare institutions of Bosnia and Herzegovina. In: XXV international conference on information, communication and automation technologies (IEEE ICAT), pp 1–5, 29–31 October 2015, Sarajevo, Bosnia and HerzegovinaGoogle Scholar
  32. 32.
    Gurbeta L, Badnjevic A, Sejdinovic D, Alic B, Abd El-Ilah L, Zunic E (2016) Software solution for tracking inspection processes of medical devices from legal metrology system. In: XIV mediterranean conference on medical and biological engineering and computing (MEDICON), 31. March–2 April 2016, Paphos, CyprusGoogle Scholar
  33. 33.
    Gurbeta L, Badnjevic A (2016) Inspection process of medical devices in healthcare institutions: software solution. Health Technol. doi: 10.1007/s12553-016-0154-2 Google Scholar
  34. 34.
    Karaböce B, Gülmez Y, Akgöz M, Kaykısızlı H, Yalçınkaya B, Dorosinskiy L (2015) Medical metrology studies at Tübitak UME. 17 international congress of metrology, 0 011Google Scholar
  35. 35.
    The role of metrology in medical devices MARIA DO CÉU FERREIRA Instituto Português da Qualidade, Portugal, OIML Bulletin Volume LII Number 4 October 2011Google Scholar

Copyright information

© Springer Nature Singapore Pte Ltd. 2018

Authors and Affiliations

  • Haris Memić
    • 1
    Email author
  • Almir Badnjević
    • 2
  • Zijad Džemić
    • 1
  1. 1.Institute of Metrology of Bosnia and HerzegovinaSarajevoBosnia and Herzegovina
  2. 2.Medical Devices Verification LaboratoryVerlab Ltd SarajevoSarajevoBosnia and Herzegovina

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