Articles and presentations by Mika Reinikainen


  • When doctors are replaced by artificial intelligence,,,, TOPRA Regulatory Rapporteur, October 2021
  • Authorised representative concerns – deadline 2020, BSI Compliance Navigator for Medical Devices, 2 August 2019
  • An overview of new and emerging medical technology, TOPRA Regulatory Rapporteur, April 2019
  • From the Directives’ ERs to the new Regulations’ GSPRs: revolution or evolution in the regulation of medical devices in the European Union?, Journal of Medical Device Regulation, 2019
  • Explaining IVD classification issues (in collaboration with Dr. Maurizio Suppo), Medical Device White Paper Series, BSI. 2019
  • General requirements for safety and performance, BSI, 2019
  • Classification issues for manufacturers transitioning to the new Regulation on Medical Devices, BSI 2017
  • Expert guidance on economic operators – importers and distributors, BSI, 2017
  • 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

Frequent workshops and training

  • Introduction to regulatory requirements for medical devices 
  • Post-market surveillance (including vigilance)
  • Risk classification and borderline determination


  • Medical Devices: Brexit and the UK Responsible Person, Educo Life Sciences,Virtual seminar, 23 April 2021 & 24 September 2021
  • Regulatory challenges: a European perspective, Health Mini-Symposium on Graphene, Virtual meeting, 7 December 2020BREXIT – Mitä tapahtuu… mahdollisesti [BREXIT – What will happen…possibly], MDR Working Group, Finnish Health Technology Association, Virtual meeting, 29.9.2020
  • 1) Post Marketing Surveillance  including vigilance and market surveillance 2) Risk Management, MDR/IVDR 3) Classification – MDR, Be Prepared for the Medical Device Regulation, Tel Aviv, Israel, 24 – 25 February 2020
  • Regulatory challenges in the path toward clinical application and beyond: a European perspective, Graphene Connect & Health Investment Forum, Barcelona, Spain, 6 November 2019
  • Workshop on Advanced Regulatory Affairs for Medical Devices, Berlin, Germany, 18 – 19 September 2019
  • Workshop “Medical Devices – The new EU Market Regulation: will you be able to comply in time?”, Business Innovation Institute, Tel Aviv, Israel, 26 – 27 June 2019
  • 1) The Road to 2020: Overview of Regulatory Developments 2) Scope, Borderlines and Classifcation 3) General Safety and Performance Requirements 4) Conficts Between Economic Operators, New European Regulations of Medical Devices, New Jersey, USA, 13-14 June 2019
  • Valtuutetut edustajat – Kokemuksia asetuksen tulkinnasta [Authorised representatives – Experiences in the interpretation of regulations], MDR Working Group, Finnish Health Technology Association, Helsinki, Finland, 22 August 2018
  • Medical Device Regulation, BrainCom Project, Oxford, UK, 28-29 June 2018
  • Drug-Device combinations: Borderlines, current and future regulatory requirements, APV Expert Workshop Drug-Device Combinations, Dortmund, Germany, 6 – 7 March 2018
  • 1) Setting the Scene: The Political and Technological Framework during the Lifetime of the New Regulatory System; 2) Scope, Borderlines and Classification; 3)Conflicts Between Economic Operators , New Medical Device Regulations – Impact on industry -The race to achieve compliance by deadline, Berlin, Germany, 16 – 17 October 2017
  • 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 PMSWorkshop 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 UKBirmingham, 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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