About us

Our purpose

MDlaw.eu was created in March 2017 as a public utility project to meet the information needs of the medical devices sector on the new regulatory framework.
Since the beginning, MDlaw.eu was owned and managed by Ajda Mihelcic. In autumn 2018, ownership has been transferred to Obelis Group with the goal to transform the platform into a reference point for both industry and other stakeholders when it comes to the European MDR and IVDR legislation.
MDlaw.eu gathers reference documents, implementation tools including checklists, guidelines, analysis documents, as well as regulatory updates, all in a single place.
Obelis Group remains committed to raise knowledge and spread information about the European MDR and IVDR – while keeping the Platform quality-driven, neutral or balanced in terms of opinions provided. Greater comprehension of the new law will help economic operators to develop efficiently innovative medical technologies and furthermore increase product safety to the benefit of patients and users.

Editorial Committee

MDlaw Editorial Committee has been developed to steer the MDlaw Platform, to offer a room for exchange of views on the new regulatory framework and to review crucial documents.
We are proud to present you the below prominent experts being part of our Editorial Committee!
Dr. Bassil Akra

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation.

Dr. Akra was the Vice President of strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products.

Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He was also actively engaged in the application and finalization of the designation and notification process of TÜV SÜD Product Service GmbH for both the MDR and IVDR.

He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

Eric A. Klasen

Life Sciences expert in Regulatory Affairs and Quality Assurance systems with focus on solutions underpinning Healthcare strategies and Business objectives.

Member of the Board of Directors and Treasurer of the European Forum of Good Clinical Practice, Belgium. Member of the Board of Directors of SimpliNext, Switzerland. Member of the Supervisory Board of DIABETER, a group of Diabetes clinics in the Netherlands, and chair of the Supervisory Board of NOK/Best Care Foundation, a group of Obesity Clinics in the Netherlands.

From July 2004 – May 2019, he was Vice President EMEA Regulatory Affairs & Quality at Medtronic International Trading, Switzerland, and founder and President of Medtronic BioPharma Europe. He retired from Medtronic in May 2019.

Prior to Medtronic, he held the following positions:

1998-2004, Head of Global Drug Regulatory Affairs at Novartis Consumer Health, Switzerland (currently GSK Consumer Healthcare).

1994-1998, Director Regulatory Compliance, Quality Assurance and Quality Control at Chiron Vaccines (currently GSK Vaccines), Italy.

1986-1994, Director R&D at Serono Diagnostics, Italy, Director Operations Technical Support at IFS (Istituto Farmacologico Serono), Italy, and Director of QA/QC at Serono Biotech, Switzerland (currently Merck–Serono).

1982-1986, Head of the Immunochemistry Department at TNO Medical Biological Laboratory, Netherlands.

1977-1982, Researcher at the Dept of Human Genetics of the University of Leiden, Netherlands.

He obtained a BSc. degree (1975) in Biochemistry and an MSc. degree (1977) in Biochemistry & Genetics from the University of Leiden, Netherlands.

John L. Webster

Mr. Webster has over 40 years of quality assurance, regulatory and management experience and served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. in UK.

Most recently, he was Principal Consultant and Managing Director of the European office of US based organisation providing medical device consulting and European Authorised Representative services. Since 2010, Mr. Webster has served as Senior Regulatory Consultant for the Obelis Group based in Brussels and providing EU Consultancy Services and Authorised Representative Services for the Medical Device and other Directives.

During the writing of the Medical Device Directive, he was responsible for technical affairs at EUCOMED representing the medical technology industry in Europe, and chaired the committee writing the Essential Requirements in Annex I of the Directive. Mr. Webster has chaired the committee responsible for writing the European standards on labelling and symbols used with medical devices (CEN/CLC/TC 3/WG 1) since its creation.

He regularly speaks at professional conferences on all aspects of medical device quality and regulatory compliance. He holds a higher degree in Chemistry from the University of Newcastle upon Tyne, is a Chartered Chemist and a member of the Royal Society of Chemistry (C.Chem, M.R.S.C.), holds a Diploma in Management Studies from the University of East Anglia, is Certified as a Quality Engineer by the American Society of Quality, is a Fellow of the Regulatory Affairs Professional Society (RAPS), serves on the European Operating Committee and is Regulatory Affairs Certified (RAC).

Mika Reinikainen

Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR).

He is the founder of Abnovo Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company focuses on regulatory strategy and compliance, as well as resolving manufacturers’ conflicts with Notifies Bodies and Competent Authorities. He also provides regulatory interpretation and advocacy, in particular on borderline determination between legal regimes.

Mr. Reinikainen has more than 30 years of experience in the European medical device field: as regulatory affairs manager in industry (Pfizer Hospital Product Group of companies), as healthcare legal counsel (Hogan & Hartson) and as as a regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles).

He was directly involved in the development of the Medical Devices Directives (chairing the working group that developed the European medical device classification system and later as a consultant to the European Commission on classification) as well as through various roles in trade associations. He also served as the  former Chairman of CEN TC 257 (technical standards).

Mr. Reinikainen is currently a member of the European Commission’s Medical Device Expert Group and of the Commission’s Working Groups on Borderlines and Classification, Software and New & Emerging Technologies. He is a former Vice President, Europe, of the Regulatory Affairs Professionals Society (RAPS).
He holds a Master’s degree in law from the University of Nice (France) and a Master’s degree in Business Administration from Wharton (University of Pennsylvania, USA).

Roland Gerard

Roland Gerard is a regulatory affairs expert with 30 years of experience in the field of high risk implantable medical devices.

Roland has worked for the European Committee for Standardization (CEN), Intermedics and more recently for St. Jude Medical where he occupied the position of Vice President RA/QA in the International Division.

During all those years, he has developed an in-depth knowledge of EU Medical Device Directives and Environment Legislation as well as standards and quality management system (ISO 13485) implementation and certification, has extensive experience in CE marking and in dealing with competent Authorities and Notified Bodies, has experience in working with senior management to support business needs, speed up market access and manage crises.

Mr. Gerard has been a member of GHTF study group 2, GHTF Steering Committee, President of RAPS Europe, President of IAPM, Chair of the Regulatory Affairs Committee of IAPM and more recently Chair of the Regulatory Affairs Committee of EUCOMED. He has been involved in numerous conferences as a speaker as well as in the development of the new Medical Devices Regulation.