Europe - UK - USA
Publications
Download free reprints of publications authored by Donawa Lifescience Consulting staff
- M.E. Donawa, Proposed MDR Amendments and Clinical Data Requirements, January 2026
- M.E. Donawa, Clarifying MDR Terminology: The Problematic Definition of ‘Similar Device’, October 2025
- M.E. Donawa, MDR Clinical Data Mandate Threatening Device Access in Europe, February 2025
- M.E. Donawa, CEPs: What Does “State of the Art” Modify? September 2024.
- M.E. Donawa, CEPs: Parameters vs clinical outcome parameters, February 2024.
- A. Ciriello, Importatori e distributori: i nuovi requisiti dei regolamenti europei – Parte 1, July 2023.
- M.E. Donawa interviewed by Amanda Maxwell for Medtech Insight, Guidance Needed To Explain Scope Of MDR’s Confusing Clinical Investigations Clause, October 2019 (subscription required).
- M.E. Donawa and S. Pesci. Avoiding delays when conducting medical device clinical or IVD performance evaluation studies in Germany, May 2019.
- M.E. Donawa. RoHS Is a RoHS Is a RoHS . . ., European Medical Device Technology, November/December 2013.
- M.E. Donawa. The Critical Task of Selecting a Notified Body, Part Two, European Medical Device Technology, September/October 2013.
- M.E. Donawa. The Critical Task of Selecting a Notified Body, Part One, European Medical Device Technology, July 2013.
- M.E. Donawa. UK Public Consultation on New Medical Device Legislation, European Medical Device Technology, Jan/Feb 2013.
- M.E. Donawa. Proposed New European Medical Device Regulations, European Medical Device Technology, Nov/Dec 2012.
- M.E. Donawa. Proposed Guidance on IVD Clinical Evidence and Performance Evaluation, European Medical Device Technology, Jul/Aug 2012.
- M.E. Donawa and R.L. Gray. The Breast Implant Scandal and European Medical Device Regulation, GMP Review, April 2012.
- M.E. Donawa. Guidance to Notified Bodies on Checking Clinical Evaluations, European Medical Device Technology, Nov/Dec 2011.
- R.L. Gray. The European Medical Device Regulatory Process (in Chinese), China Medical Device Manufacturer, Summer 2011.
- C. d’Alessandro. IVD Directive Recast – What’s in Store? White Paper, Aug 2011.
- M.E. Donawa. European Medical Device Usability Requirements, European Medical Device Technology, Jun 2011.
- M.E. Donawa. The Notified Body Consultation Procedure; Part 2, European Medical Device Technology, Feb 2011.
- M.E. Donawa. The Notified Body Consultation Procedure; Part 1, European Medical Device Technology, Jan 2011.
- M.E. Donawa. Newly Updated European Classification Guidance, European Medical Device Technology, Sept 2010.
- M.E. Donawa. European Device Regulatory Revolution: A Personal View, European Medical Device Technology, Jun 2010.
- M.E. Donawa. Revised European Guidance on Clinical Evaluations: Part 2, European Medical Device Technology, Apr 2010.
- M.E. Donawa. Revised European Guidance on Clinical Evaluations: Part 1, European Medical Device Technology, Mar 2010.
- M.E. Donawa. New European Device Clinical Requirements: Part 2, European Medical Device Technology, Feb 2010.
- M.E. Donawa. New European Device Clinical Requirements: Part 1, European Medical Device Technology, Jan 2010.
- M.E. Donawa. New European Guidance on Borderline Products, Medical Device Technology, Sept 2009.
- A.J. Vaughan. Environmental Legislation in the EU – What Medical Device Manufacturers Need to Know, Regulatory Affairs Journal, Jan/Feb 2009.
- M.E. Donawa. Addressing European Environmental Legislation. Medical Device Technology, Jan/Feb 2009.
- R.L. Gray. A Regulatory Primer – Critical Regulatory Issues, Hurdles, Myths, and Realities, Examined, Explored, Explained, The Trendletter, December 2008.
- M.E. Donawa. The Evolving Process of European Combination Product Review Part 2. Medical Device Technology Nov/Dec 2008.
- M.E. Donawa. The Evolving Process of European Combination Product Review Part 1. Medical Device Technology October 2008.
- M.E. Donawa. Addressing US and European Device Testing Requirements. Medical Device Technology September 2008.
- M.E. Donawa. New Italian Device Registration Requirements. Medical Device Technology May/Jun 2008.
- R.L. Gray. Revised EU Directives: Many Changes in Store. Medical Device & Diagnostic Industry Feb 2008.
- M.E. Donawa. Scope of the European Medical Device Directives. Medical Device Technology Jan/Feb 2008.
- M.E. Donawa. Implementing New European Vigilance Requirements. Medical Device Technology Nov/Dec 2007.
- M.E. Donawa. Competent Authority Conference on Medical Devices. Medical Device Technology Sept 2007.
- R.L. Gray. Understanding the Italian Device Registration Process. ABHI Focus, Sept 2007.
- R.L. Gray. Postmarket Vigilance in Europe: New Guidance for Manufacturers. Medical Device & Diagnostic Industry Sept 2007.
- M.E. Donawa. Organising European Technical Documentation to Avoid Duplication. Medical Device Technology Apr 2006.
- M.E. Donawa. Proposed Amendments to the Medical Devices Directives. Medical Device Technology Jan-Feb 2006.
- M.E. Donawa. US and European Postmarket Clinical Data Requirements. Medical Device Technology Mar 2005
- M.E. Donawa, European Animal Tissue Directive, Medical Device Technology Jan-Feb 2004
- M.E. Donawa, European Medical Device Regulation: A New Era?, Medical Device Technology Dec 2004
- M.E. Donawa. Updated regulations on FDA acceptance of clinical data in effect soon, Donawa Lifescience Consulting, February 2019.
- M.E. Donawa. What You Need to Know About FDA IVD Test Requirements, European Medical Device Technology, Autumn 2014.
- M.E. Donawa. US FDA Publishes Proposed Rule on Non-US Studies, European Medical Device Technology, May/Jun 2013.
- M.E. Donawa. New US Regulation on CGMPs for Combination Products, European Medical Device Technology, Mar/Apr 2013.
- M.E. Donawa. The Pre-IDE Programme Becomes the Pre-Submission Programme, European Medical Device Technology, Sep/Oct 2012.
- M.E. Donawa. Early Feasibility Medical Device Clinical Studies, European Medical Device Technology, January-February 2012
- M.E.Donawa. US FDA Draft Revised Guidance on when to Submit a New 510(k), European Medical Device Technology, September 2011
- R.L. Gray. The US Medical Device Regulatory Process (in Chinese), China Medical Device Manufacturer, Autumn 2011.
- M.E.Donawa. Continuing Evolution of the US FDA 510(k) Process, European Medical Device Technology, October 2010
- M.E. Donawa. The Evolving US 510(k) Review Process, European Medical Device Technology, May 2010
- M.E. Donawa. US Regulation of Combination Products. Medical Device Technology October 2009
- R.L. Gray. A Regulatory Primer – Critical Regulatory Issues, Hurdles, Myths, and Realities, Examined, Explored, Explained, The Trendletter, December 2008.
- M.E. Donawa. Addressing US and European Device Testing Requirements. Medical Device Technology September 2008.
- M.E. Donawa. Who owns the 510(k)? Medical Device Technology Mar/Apr 2008
- M.E. Donawa. Strategic Planning For US Premarket Approval Submissions. Medical Device Technology Sep 2006
- M.E. Donawa. US Regulation of Advertising and Promotional Materials. Medical Device Technology May 2006
- M.E. Donawa. US Guidance on Formatting 510(k)s. Medical Device Technology Mar 2006
- M.E. Donawa, Useful US Guidance on Device Software, Medical Device Technology Dec 2005
- M.E. Donawa. US Importer and Distributor Requirements. Medical Device Technology Jun 2005
- M.E. Donawa. US Medical Device Reporting: Who Is Responsible? Medical Device Technology Apr 2005
- M.E. Donawa. US and European Postmarket Clinical Data Requirements. Medical Device Technology Mar 2005
- M.E. Donawa. FDA Draft Guidance on Computerised Systems Used in Clinical Trials. Medical Device Technology Jan-Feb 2005
- M.E. Donawa, Beyond the US Submission Process, Medical Device Technology Apr 2004
- M.E. Donawa interviewed by Amanda Maxwell for Medtech Insight, Guidance Needed To Explain Scope Of MDR’s Confusing Clinical Investigations Clause, October 2019 (subscription required).
- M.E. Donawa and S. Pesci. Avoiding delays when conducting medical device clinical or IVD performance evaluation studies in Germany, May 2019.
- M.E. Donawa. Updated regulations on FDA acceptance of clinical data in effect soon, Donawa Lifescience Consulting, February 2019.
- M.E. Donawa. Adverse Event Reporting in European Premarket Clinical Studies, European Medical Device Technology, Spring 2015.
- M.E. Donawa, How Will Proposed Changes to European Regulation Affect Clinical Data Requirements? European Medical Device Technology, Spring 2014.
- M.E. Donawa. US FDA Publishes Proposed Rule on Non-US Studies, European Medical Device Technology, May/Jun 2013.
- M.E. Donawa. Proposed Guidance on IVD Clinical Evidence and Performance Evaluation, European Medical Device Technology, Jul/Aug 2012.
- M.E. Donawa. In Vitro Diagnostic Performance Evaluation Studies: Part 2, European Medical Device Technology, May 2011.
- M.E. Donawa. In Vitro Diagnostic Performance Evaluation Studies: Part 1, European Medical Device Technology, April 2011.
- M.E. Donawa. Serious Adverse Event Reporting During European Device Clinical Investigations, European Medical Device Technology, March 2011.
- M.E.Donawa. Revised Medical Device Clinical Study Standard Introduces Sweeping Changes, European Medical Device Technology, Nov/Dec 2010.
- M.E. Donawa. Revised European Guidance on Clinical Evaluations: Part 2, European Medical Device Technology, Apr 2010.
- M.E. Donawa. Revised European Guidance on Clinical Evaluations: Part 1, European Medical Device Technology, Mar 2010.
- M.E. Donawa. New European Device Clinical Requirements: Part 2, European Medical Device Technology, Feb 2010.
- M.E. Donawa. New European Device Clinical Requirements: Part 1, European Medical Device Technology, Jan 2010
- M.E. Donawa. Clinical Studies in Italy, Medical Device Technology, Nov/Dec 2009
- M.E. Donawa. Auditing Device Clinical Studies for US Requirements. Medical Device Technology Oct 2007
- M.E. Donawa. Insurance Coverage for European Device Clinical Studies, Medical Device Technology Feb 2007
- M.E. Donawa. New Efforts to Harmonise Clinical Evaluation, Medical Device Technology Nov 2006
- M.E. Donawa, Managing Clinical Data For Worldwide Acceptance, Medical Device Technology Oct 2006
- M.E. Donawa, Conducting Clinical Studies in Italy, Medical Device Technology Oct 2005
- M.E. Donawa. US and European Postmarket Clinical Data Requirements. Medical Device Technology Mar 2005
- M.E. Donawa, Successful Recruitment for Medical Device Clinical Studies, Medical Device Technology Oct 2004
- M.E. Donawa, Avoiding Rejections by European Ethics Committees, Medical Device Technology, Jun 2003
- M.E. Donawa, US Inspections of Clinical Investigation Sites, Medical Device Technology June 2001
- M.E. Donawa. Preparing for a US FDA Medical Device Inspection, Part 2. European Medical Device Technology May 2012.
- M.E. Donawa. Preparing for a US FDA Medical Device Inspection, Part 1. European Medical Device Technology Mar/Apr 2012.
- M.E. Donawa. Meeting US and European Supplier Control Requirements. Medical Device Technology May/Jun 2009.
- M.E. Donawa. Avoiding Surprises When Implementing a Single Quality System. Medical Device Technology Mar/Apr 2009.
- M.E. Donawa. Effectively Incorporating Risk Management into Quality Systems. Medical Device Technology Jun 2006.
- M.E. Donawa. European Requirements for Product Returns. Medical Device Technology Nov 2005
- M.E. Donawa. Preparing for More Active Market Surveillance. Medical Device Technology May 2005
- M.E. Donawa, Guidance on Submitting Quality System Information, Medical Device Technology Mar 2004
