Articles and presentations by Mika Reinikainen


  • Human enhancement: will the integration of technology and humanity create a regulatory dilemma?, Clinica, 29 November 2010
  • Standalone software as a medical device: Regulatory issues, TOPRA Regulatory Rapporteur, May 2010
  • The New Approach Revision: Impact on the Regulation of Devices in the EU, RAJ Devices, July/August 2008
  • Analysis of the impact of the MDD review amendments on active implants, Clinica, 27 April 2007
  • Analysis of the impact of MDD review amendments, Clinica, 6 April 2007
  • Authorised representation – an essential element of the European regulatory system for medical devices, Business Briefing: Medical Device Manufacturing & Technology 2004, Touch Briefings, August 2004


  • Software as a medical device: recent developments relating to standalone software in the European Union, Annual Conference of the Regulatory Affairs Professionals Society, San Jose, California, USA,  24–27 October 2010
  • Luokintamuutokset [Changes in classification], Webinar, FIHTA, 15 September 2010
  • Medical device classification, Medical Device Summer School, Pharmaceutical Training International,  London, UK, 8 – 10 September 2010
  • Post-market surveillance ja tuotteen elinkaaren hallinta [Post-Market surveillance and the management of the product life cycle], Turun Ammattikorkeakoulu, Turku, Finland 28.5.2010
  • Registration and regulation:  understand the time and cost, ABHI International Business Conference, London, UK, 13 May 2010
  • Classification of medical devices, Medical Device Spring School, Pharmaceutical Training International,  London, UK, 10 – 12 May 2010
  • Update on the current legal and compliance – challenges for medical device manufacturers, Medical Device Law and Compliance Forum, Informa, Brussels, Belgium, 6 – 7 May 2010 [EC]
  • Software as a medical device: European legal and regulatory basis, Medtec UK, Birmingham, UK,  27 – 28 April 2010
  • Software as a medical device: European legal and regulatory basis, Medtec Europe Conference, Stuttgart, Germany, 23 – 25 March 2010
  • Basic legal and general aspects of PMS, Workshop on Practical Issues in Developing a Strategy and Organisation for PMS, Informa, 5th Annual Conference on Medical Device Post Market Surveillance & Vigilance , Berlin. Germany, 16 – 18 February 2010
  • Developing effective clinical studies for combination products, Biomedevice Conference, Paris, France , 1 – 2 February 2010
  • Update on classification and Revision of the New Approach, Informa, 4th Annual The Medical Device Directive Conference, Brussels, Belgium, 27 -29 January 2010
  • Drug/device borderline – latest developments, Informa, 4th Annual conference on Drug Device Combination Products, Prague, Czech Republic, 18 November 2009; Basic legal and general aspects of PMS during a workshop on Post Market Surveillance for Combination Products
  • Direktiivin 2007/47/EY (medical devices) sisältö ja merkitys alan eri toimijoille (The contents and significance of Directive 2007/47/EC to different stakeholders in the field) and Laiteluokittelu, raja-alueet, tulkintaohjeet, MEDDEV-oppaat – mitä uutta on tulossa (Device classification, borderlines, guidance, MEDDEV documents – what else is coming), Uudet vaatimukset – Terveydenhuollon laitteet ja ohjelmistot – Mikä muuttuu 21.3.2010? [New requirements for medical devices and software – what changes on 21.3.2009?], Helsinki-Vantaa, Finland, 11 November 2009
  • The Borderline and Classification Work Group – industry perspective, TOPRA Medical Devices Symposium, Stockholm, Sweden, 8 October 2009
  • Regulatory framework for combination products in the EC, Medtec Ireland, Galway, Ireland, 23 – 24 September 2009
  • Medical device classification, Informa, Medical Device Summer School, Cambridge, UK, 7 – 9 September 2009
  • The future of medical device labelling in Europe and Conducting clinical trials under the revision, Medtec UK, Birmingham, UK, 25 – 26 March 2009
  • The future of medical regulations in Europe, MEDTEC Europe, Stuttgart, Germany, March 3-5, 2009
  • Interface of the medical devices directives with other legislation, Informa, Managing the Revisions to the Medical Device Directive, Informa, Brussels, Belgium, 27-29 January 2009; Basic legal and general aspects of Post-Market Surveillance during a workshop on How to conduct Post Market Surveillance correctly
  • Issues and specifics in clinical development of combination products, Course on Regulation of Combination Products and Other Technologies in the EU, University of Cranfield, UK, 11 December 2008
  • How have the revisions to the Medical Device Directive impacted on combination product approval?”, Informa 3rd annual conference on Drug Device Combination Products, Barcelona, Spain, 27 – 29 October 2008; Combination products: legal considerations in borderline determination and clinical implications during a workshop on Developing effective clinical studies for combination products
  • The revision of the New Approach, Eucomed Regulatory Committee, Brussels, Belgium, 13 – 14 October 2008
  • Borderline issues: The demarcation of medical devices from other products: medicinal products, ATMPs, machinery, PPEs, food supplements and cosmetics, Medical Device Law and Compliance Forum, Brussels, Belgium, September 23 – 24, 2008
  • Overview of the EU medical device regulatory framework and the role of EAAR and authorized representatives in It, RAPS Annual Conference, Boston, USA, 14 – 17 September, 2008
  • Medical device legislation and Competent authorities, TOPRA Medical Devices Regulatory Affairs course, Manchester, UK, 10 – 12 June 2008
  • Changes in classification and legal regime borderline, Medtec Europe, Stuttgart, Germany, 11 March 2008
  • Current state and future evolution of European regulatory requirements, Medtec UK, Birmingham, UK, 13-14 February 2008
  • Strategies for achieving the CE mark for combination products quickly and with minimal complexities, Drug Device Combination Products, Brussels, Belgium, 4 – 5 December 2007
  • Implementation and update on the revision to the Medical Devices Directive, Medtec Ireland, Galway, Ireland, 19 September 2007
  • Vigilance reporting and revision of the Medical Devices Directive (MDD), Medtec UK, Birmingham, UK, 14 February 2007
  • Introduction to the Medical Devices Directives and Classification, An Introduction to Medical Device Regulations, Informa Workshop, Brussels, Belgium, 29 January 2007
  • Revision of the Medical Devices Directive (MDD), Medtec UK, Birmingham, UK, 15-16 February 2006
  • Medical devices in Asia-Pacific markets: global perspective, Conference on Medical Device Regulations in Asia-Pacific Markets, Management Forum, London, UK, 10 November 2005
  • The new Europe: overview for device manufacturers, Webinar, Foreign Exchange Translations,  16 September, 2004
  • Review of the medical device directives: industry view, RAPS 2004 European Symposium, Paris, France, 6 – 8 September 2004
  • Reclassification of medical devices, Conference on Safeguarding Medical Devices – Managing Legal and Regulatory Risk to Protect Your Products and Users Across an Expanded Europe, The Lawyer Conferences, Brussels, Belgium, 29 – 30 January 2004
  • Increased requirements for European authorized representatives, RAPS Annual Conference, Baltimore, Maryland, USA, 19 – 22 October 2003
  • National implementation of vigilance systems, Conference on Post-Market Surveillance and Risk Management, IBC, London, UK, 11 December 2001
  • Revision of the medical device directive (93/42/EEC) (MDD), OSMA meeting, 27 April 27 2001, Annapolis, Maryland, USA
  • Examining vigilance and legal enforcement, Conference on Medical Device Vigilance Reporting, IIR, London, UK, 19 – 20 February 2001
  • How to comply with the requirements of authorized representation, In Vitro Diagnostic European Conference, Advanstar Communications, Paris, France, 25 – 26 September 2000

If you are interested in articles or presentations from before 2000 please email

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