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Quality Nightmares #37: The Matador

29 March 2018

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MasterControl Sponsors Free RAPS Webinar: Preparing for Medical Device Single Audit Program (MDSAP) Audit Success

15 March 2018

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How an EQMS can make the transition to MDR seamless

14 December 2017

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Contact: Theresa Gubler, Association Relations, MasterControl
Phone: 816.634.0725

MasterControl Hosts BioUtah’s Medical Device Regulation EU 2017/745 Seminar

SALT LAKE CITY, UTAH, USA¬ – July 30, 2018 - - MasterControl Inc., a leading global provider of software solutions that enable life science and other regulated companies to deliver life‐improving products to more people sooner, hosted BioUtah’s Medical Device Regulation EU 2017/745 seminar on July 25, 2018. Utah life science and regulatory affairs professionals heard directly from one of Europe's leading regulatory authorities, Dr. Michael Rinck, a dignitary from the German state of Saarland. As part of an economic cooperative agreement between Utah and the Saarland Economic Promotion Corporation (gwSaar), Dr. Rinck presented a half-day seminar on significant regulatory changes in Europe.

Dr. Rinck, managing director, pharmacist and microbiologist, MT Promedt Consulting GmbH, discussed facets of the new European medical device regulation that are creating major changes to the way medical device manufacturers deliver their products to the European market while remaining compliant through a device’s life cycle.

Dr. Rinck explained that on June 27, 2016, the final drafts of the Medical Device Regulation (MDR) and In-vitro Medical Device Regulation (IVDR) became public and enforceable as of May 26, 2017. The transition period will be three years for the MDR and five years for the IVDR, meaning that the dates of application will be May 26, 2020 and May 26, 2022, respectively.

Among other enforcements, the new directive EU MDR will:

  • Apply stricter pre-market control of high-risk devices at an EU level
  • Provide a new risk classification system for diagnostic medical devices
  • Allow better supply chain traceability from manufacturers to end users
  • Reinforce rules on medical device clinical data and clinical studies
  • Encourage manufacturers to collect real-world data for devices

Dr. Rinck stressed that companies do not have three or five years to prepare for compliance with these regulations. He said that medical device manufacturers need to be managing the transition process now, so funding and other resources can be available for implementing the regulations.

One of the roadblocks companies may encounter lies in locating a Notified Body (NB) to help them with their transition. Notified Bodies will have to apply for and receive new designations to demonstrate their compliance with MDR. There is concern that the number of NBs available to help manufacturers attain compliance will decrease. A decreasing number of available NBs means there will be a bottleneck for medical device companies seeking approval and designation, leading to a possible bidding war for their services, according to Dr. Rinck.

Dr. Rinck stressed the need for post-market surveillance and post-market clinical follow-up. He said companies must update their clinical data, technical documentation and labeling programs to remain or become compliant.

A breakfast reception opened the meeting and a question and answer period was held at the end of the presentation for guests to meet Dr. Rinck.

About BioUtah

BioUtah is an independent, non-profit 501(c)(6) trade association serving Utah's life science industry. Its primary members include organizations focused on research and development, manufacturing and commercialization or support services to life science technologies and treatments.

About MasterControl

MasterControl Inc. produces enterprise software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit MasterControl Inc.