On May 25th, 2017 a novel Medical Device Regulation (MDR) came into effect for the European Union, triggering a transition period of three years before the current Medical Device Directive (MDD) will be obsoleted by May 24th, 2020 . Even before this date new revisions of the guidelines for the assessment of a Clinical Investigations (MEDDEV 2.7/2, 2015) and performance of a Clinical Evaluation (MEDDEV 2.7/1_Revision 4, 2016) came into force to ascertian an adequate Validation and Assessment of Regulatory Conformity for Medical Devices in Europe.Simultaneously also for Medical Device Quality Management Systems (QMS) complying with the ISO 13485 standard the transition period to it's most recent version (ISO 13485:2016) ends by February 28th, 2019. By then a risk based QMS approach needs to be demonstrated to comply with the new standard and obtain the re-certification under ISO 13485:2016, which is critical to our industry.
MD squared offers advice in assessing how your current Medical Device Portfolio and future product releases will be impacted by these novel rules and standards, how to navigate the transition and how to establish an effective compliance to the latest Quality Standards and Regulatory Requirements for Medical Devices..
MD squared is certified as Manager Regulatory Affairs - Medical Devices and Manager Regulatory Affairs International by TUEV SUED Academy, as Lead Auditor ISO 13485:2016 (Quality Management Systenms for Medical Devices) by the British Standards Institution (BSI) and is registered as a general practicioner (basisarts) at the Dutch Physician's Registry (BIG-register)