The European Parliament, with its infinite wisdom, has voted to accept the European Commission’s proposal to postpone the date of application for the medical device directive until 26 May 2021. Barring a major political catastrophe, the amendment will be published in the Official Journal.
The United Kingdom is no longer represented with MEPs, so therefore did not participate in the vote. Following the transition period, the UK will not be part of the European Economic Union, nor required to abide by EU legislation from 31 December 2020 (at least according to the last Brexit statement by Mr Johnson.)
The MHRA adopted the MDR legislation almost in its entirety, bar a couple of additions. That adoption also included acceptance of 26 May 2020 as date for application. The MHRA guidances “Medical Devices: how to comply with legal requirements” was last updated in Feb 2019 and “Medical Devices: EU regulations for MDR and IVDR” was last updated October 2018. Neither guidance mentions the possibility of the current delay.
Will the MHRA expect adherence to the 26 May 2020 date of application for MDR for medical devices marketed (also would include European imports) in the United Kingdom even though the UK was not represented in the parliamentary vote?
I would very much welcome any feedback on when and/or whether the MHRA will also delay application of the UKs relevant MDR legislation during this transition period. Please email me at email@example.com.
Welcome to my first posting for the RIMtelligence blog. As this is number one, let’s start at the beginning. Once upon a time, the regulatory function was not particularly well-defined and seemed to be more focussed on pagination than content. Are they Scientists? Medical Writers? Lawyers? Programme Managers? The answer of course is, all of the above and then some!
Throughout my professional career, I have enthusiastically witnessed an incredible transformation in regulatory affairs roles and responsibilities. No longer are we relegated to hole punching, paper copying and ink stamping. Technological and innovative advances in the Life Sciences field have enabled the industry to produce pharmaceutical cures, medical device software apps and gene spliced biologics. As the manufacture and testing of drugs, devices and biologics become more complex, the inherent risks increase. Mitigation of the risks are paramount for the patients and healthcare professionals. One method to support this important risk mitigation process is via health authority legislation. We, as regulatory professionals, are tasked to support the development and continued maintenance of these life changing interventions in an ever-evolving global regulatory environment.
Regulatory affairs teams of the 2000’s have a greater strategic role to play. We are no longer the closed door to innovation but a supportive guide through the quagmire of the guidances, acts and directives. We have progressed from liaison to diplomat, from undermined to subject matter expert and from following SOPs to leading strategic initiatives. The requirements of the regulatory skill set now includes an increased communication aptitude both internally (cross-functional teams) and externally (health authorities). Computer programmes have increased efficiency for medical writing, document publishing and data storage, requiring another specialised competence. Regulatory teams are constantly challenged to obtain approvals faster for which we wear multiple hats. Many companies have added a regulatory responsible member to their executive committees thus recognising the importance of the role. We are now a vital team member in the innovation funnel, from concept to discontinuation.
Our various regulatory roles (assistant, specialist, project manager, operations, intelligence etc.) come with great responsibility. I look forward to discussing a wide range of topics and some of the challenges faced when performing our day-to-day tasks. Please feel free to drop me a note if you would like to comment, discuss a topic that is close to you or even rant about an unforeseen challenge.
Thank you for reading and I look forward to further engagement.
Welcome to RIMtelligence, Instem’s new bi-weekly blog. We are excited to develop an online community where regulatory professionals can follow our subject matter experts to read and share insights about some of the most important matters facing all of us today. From regulatory updates and compliance, to learning about trends for streamlining processes to increasing efficiencies, we hope this becomes a regular destination for you.
Meeting with clients and prospects around the world, we know the specific challenges the Medical Device industry is faced with – unprecedented change, driven by the need for technology innovation amidst a rapidly-evolving, global regulatory framework.
We believe that Instem is uniquely positioned and look forward to offer insight and expert opinions to help you navigate the new and ever-changing regulatory environment.
Look for blog posts from us every other Thursday. And, reach out if you have any suggestions for content or want to comment on the current topic. You can email Kim Young, Instem’s Regulatory Intelligence subject matter expert and RIMtelligence’s primary author, at firstname.lastname@example.org.
While we have your attention, join us for a TOPRA Course-Webcast on Wednesday, April 22nd to learn how to ensure sustained compliance with the EU-MDR and IVDR utilizing end-to-end technology operations automation. More information can be found here: https://bit.ly/3b57o6y.