Thursday Thoughts….

Communicating Regulatory Information

Everyone, especially senior regulatory executives, has a preference for communication styles. Does your line manager request a departmental update via a one-hour presentation with lots of colourful graphics, an email composed of <200 words or a 10-minute telephone call? Regulatory professionals spend enough time justifying their role without supplementing any negative perception by presenting information to key stakeholders utilising the wrong approach. Each of these information dissemination scenarios are difficult to fulfil if your regulatory data is inaccessible or at worse, inaccurate. The ability to easily access your up-to-date regulatory data in multiple formats and layouts will provide you and your team with the ability to prepare personalised communications for each audience. Once your regulatory data is effectively sorted, communications become a piece of cake (or pie)!

More discussion on this topic soon.

Please contact me to discuss topics related to regulatory communication challenges at KimYoung@Instem.com

K Young

Economic Operators: A new relationship with medical device regulations

Attention all manufacturers. Are you aware that if an Economic Operator (EO) considers your medical device to not be in conformity with MDR requirements, they are obligated to inform the competent authorities, thus impeding progress of your supply chain channels?

The European medical device regulation places more direct responsibility on individual entities in the medical device supply chain. Who are they? Who is responsible for informing these businesses of their responsibilities according to the MDR? How are they to manage their new roles?

Something I continue to find amazing is during this 3 (now 4) year transition period, many legal manufacturers, who have principal visibility of the MDR, have not yet engaged with their economic operators to review and update contractual agreements for data sharing.

If you are a business located within the EU and place a medical device from a third country on the market in the EU, your business, large or small, is defined as an Economic Operator: Importer as per the MDR with prescribed legal obligations. Two such obligations are keeping a register of complaints and the ability to provide the competent authorities with documentation demonstrating compliance.

As an importer managing 1000’s of different devices, received from multiple manufacturers, you must be equipped with the right tools to satisfy these additional data requirements for each and every medical device that pass through your doors. 

Other additional Economic Operators (EOs) described within MDR having legal obligations are the manufacturers themselves, authorised representatives, distributors, end sterilisers and re-packagers.

It is absolutely critical for all parties to establish and confirm the management of the mandatory data exchange requirements to support each entity’s legal obligations. And given that manufactures have the largest stake in maintaining compliance, it behoves you to lead the dialogue with their affiliates. Whether the EO roles are internal or external, well established processes supported by the right technology are necessary for assuring correct and accurate data is available for each designation. Your confidential data must be managed within a secured network with all roles and permissions clearly identified.

I strongly suggest

  • European importers, distributors, re-packagers, re-labellers, replacement part retailers, authorised representatives, procedure pack assemblers and steriliser firms immediately engage with their medical device manufacturers to understand how they will manage data exchange
  • medical device manufacturers provide support for their EOs, as many remain unfamiliar with the regulations, in order to safeguard and maintain a continuous supply chain

Please refer the specific articles of the Medical Device Regulations if you are unsure whether your business meets the criteria for an Economic Operator: https://eur-lex.europa.eu/MDR (EU) 2017/745.

I’d love to hear your thoughts.  Email me at kimyoung@instem.com.

K Young

MDR Delay and Consequences for the UK

Please be advised that on the same day of this original blog posting, 24 April 2020, the MHRA amended the “Medical Devices: EU regulations for MDR and IVDR” which finally provided an official UK update on the delay to full implementation. The details may be found at https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

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?

Also, I found it strange that shortly following the delay decision, BSI posted the following on LinkedIn:  https://www.linkedin.com/posts/bsi-medical-devices_brexit-bsi-mdr-activity-6658629726594187264-YC69 The language of the introduction seems to suggest that the video will address the delay, however Dr. Halliday’s video was recorded prior to the EU commissions proposal. The post doesn’t have any comments.

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 kimyoung@instem.com.

I guess we will all need to watch this space.

K Young

A blog posting that doesn’t mention COVID-19 or MDR…

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.

RIMtelligence Goes Live!

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 kimyoung@instem.com.

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.

Happy reading!