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Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area

On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European Regulatory framework, Member States were allowed to send comments and suggestions up until March 20th of this year. Then, on May 5th,2019 the official documents for the (EU) MDR 2017/745 and IVDR 2017/746 corrigenda were released by the Official Journal of the European Union.

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    The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope of EMA’s activities and should be read in alignment with the new Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on In Vitro Diagnostic medical devices.

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       A recent survey was conducted by Team-NB to determine how notified bodies were approaching the application process for designation under the new EU IVDR 2017/746. The survey report was closed on January 11th, 2019 and reveals that a total of 35 notified bodies responded, twenty of those were members of Team NB and fifteen were not (non-members NB).

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November 26th , 2017 saw Notified Bodies able to engage with their designated Competent Authority (CA) to apply for a notification status under the EU MD (2017/745) and/or IVD (2017/746) regulations.

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      Since its publication, many articles have been published regarding the potential implications of the new European Medical Device Regulation (MDR) on the CE-marked medical devices within the European Union. However this change of regulation goes further than only the European Union (EU) and affects also other European countries (Not European Union Member-State).

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A survey was recently administered by ISO TC210 WG1 to obtain critical information to evaluate the experiences of key stakeholders such as, medical device manufacturers, subcontractors, suppliers, European Authorized Representatives, specialized consulting firms etc., during the ISO 13485:2016 transition. ISO TC210 is a taskforce focused on the quality and performance of medical devices. They have numerous deliverables that consist of, standards, risk management, guidance documents, usability, and quality management, to name a few.

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Join us on Wednesday, September 26th, 2018, 2:00 Eastern Time as GMED North America Inc. will be hosting a free informative session on Stepping into an MDSAP audit.

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Health Canada published on August 21st, 2018 a notice confirming its “intention to Adopt the Use of the Table of Contents Format for Class III and IV Premarket Medical Device Licence Applications”, a gesture towards the efforts sustained by the IMDRF group to support medical device market authorization requests and encourage the global convergence of documentation requirements for medical devices and in vitro diagnostics.

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Meet our speakers!

Vancouver Convention Centre West |Canada| October 1 - 4, 2018 |

Booth #415

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From one Medical Device Manufacturer to another, from one Notified Body to a Medical Device Manufacturer or from one Competent Authority to a Medical Device manufacturer, from Standards to Standards or Regulations, the word “Performance” can be used in a wide different way.

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