Thursday Thoughts: Ugly Data

Do you currently support your lead revenue generating, life-enhancing product with a collection of bench studies from 20 years ago? Can you effectively follow the history of the product data from when it was called project Heart to Heart3, then on to Tech4567 and finally PaceMaker Elite Mach 76A with titanium?

We all know that true beauty comes from within and is recognised via the eye of the beholder. In the case of medical device regulatory supporting data, the eyes beholden the beauty are notified bodies, competent authorities, external auditors and health regulators. Adding a pretty new frock or snazzy tie will not improve inadequate inherent beauty or the mandatory quality of your most precious enterprise asset.

Even if, at first glance, the regulatory data may look quite fetching, lulling you into a false sense of security…..remember “beauty is only skin deep, ugly goes clean to the bone”. Now is the time to take that deep dive into the data stores to uncover the ugly hiding underneath which may place your medical device products at a risk of non-compliance.

Your regulatory data may need a complete makeover

I am pretty handy with a paint brush, email me at KimYoung@instem.com

K Young

Internal Intelligence Supports Change Strategy

Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”

As global regulatory requirements evolve and become increasingly more complex, a solid regulatory strategy for changes, followed by a determined execution, can maximise the opportunity to achieve the identified regulatory goals and provide the ever-elusive competitive advantage for revenue generation.

A suitable approach to regulatory strategy for product changes begins by engaging with internal cross-functional stakeholders to identify those product attributes that may have regulatory impact such as revised intended use, new target market, additional clinical study requirements, etc. Regulatory teams will then conduct a regulatory intelligence analysis on possible precedents, document the proposed strategy, verify the strategy’s viability and finally by reassessing (and when necessary, updating) the strategy as and when circumstances change.

Consideration must be made on what was been done before, what worked for other organisations and, just as importantly, which prior executed strategies were not successful. Key risks, barriers, critical assumptions, issues or questions must be confirmed or resolved. The strategic process must proactively recognise any challenges that may be responsible for delays for the proposed change implementation. Opportunities for positive engagement with the impacted global regulatory authorities should also be encouraged.

Internal regulatory intelligence is a key source of data for strategic planning. Regulatory teams are required to access and review historical product and registration data such as:

  • All registration history for the impacted products and regions
  • Average time from submission of change request to health authority approvals
  • Previously received queries from HA concerning changes and acceptance of company responses
  • Quality and quantity of interactions with specific HA personnel
  • Which products in a different product family with the same or similar change were managed successfully
  • Which implemented regulatory change strategies in the targeted regions were not successful and required re-submission or withdrawal
  • Lessons learned

Without a centralised repository for product and registration data, regulatory teams will struggle to obtain the strategically valuable key information unique to their organisations that is essential to provide regulatory guidance to business executives. Do not allow a flawed regulatory strategy, due to lack of accurate internal data, be accountable for your change not to happen.

KimYoung@instem.com

K Young

PFS – Combination Product or Not?

I recently read with interest a comment by a regulatory colleague about how a pre-filled syringe (PFS) should continue to be regulated as a drug with a primary package rather than a combination product for the principal reason that the product has been on the market for many years and has been proven safe and effective.

Well…. if a syringe without content is regulated as a device, then why would prefilling the device with a drug change its regulatory requirements for registration/approval? Does prefilling the device supersede the product’s device categorisation even though the syringe maintains the same intended use?

GMDN: General-purpose syringe/needle

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

To what standard do we regulate changes to this “primary package” for the PFS? Same as for a hard shell capsule?

At what point does the product change categorisation
from a drug with a primary package
to this device?

I understand, regulatory affairs personnel occupying various roles in pharmaceutical companies without a medical device portfolio may find the compliance requirements related to both FDA’s 21 CFR 3.2(e)(1) and MDR Article 117 onerous and inconvenient. However, these requirements that one may consider an inconvenience are in fact necessary to apply a globally recognised and consistent regulatory approach to support the continued validation of the safety and efficacy of this combined drug/device product.

Please feel free to contact me to discuss your drug/device combination product RIM requirements. KimYoung@instem.com

K Young

Can you Identify your Critical Suppliers?

Can you identify your critical suppliers, link each to their respective product codes and global registration status? Many medical device regulatory affairs teams struggle to connect these dots.

Firstly, who is a critical supplier and why are they important?

“2.2 Critical supplier: A critical supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the device. Note: In the context of the audit of medical device manufacturers, a critical supplier is a supplier of a product or service, the failure of which to meet specified requirements could cause unreasonable risk to the patient, clinician or others, or could cause a significant degradation in performance. This can include suppliers of services, which are needed for compliance with QMS or regulatory requirements, e.g. internal audit contractors or Authorised Representatives.”

Compilation of MDR compliant technical documentation necessitates identification of all sites, including suppliers where design and manufacturing activities are performed.

Annex VII of the MDR requires your notified body to “identify links between, and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers of the manufacturer, and consider the need to specifically audit any of those suppliers”

“…if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer’s suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers”. Notified bodies are expected to perform unannounced audits of your named suppliers, where applicable.

Ensure you connect the dots.

Cross-functional deliberations on the strategy and approach for ensuring medical device suppliers are identified, controlled and managed appropriately via QMS will only succeed if the data is accurately connected within your regulatory information management (RIM) system. Global and regional regulatory operations teams support this process by maintaining adequate linkage, tracking and data retrieval of supplier information per product code.

Feel free to contact me at kimyoung@instem.com for information on how to support supplier data management.

K Young

And now…EUDAMEDgate

Emergo’s blog and EUDAMED.eu Richard Houlihan have announced that specific portals of the postponed European EUDAMED database will made available prior to the officially published May 2022 date of implementation:

  • Actor registration: March 2021
  • UDI/Device: May 2021
  • Certificate/Notified Body: May 2021

Even without knowing whether data entry will be voluntary or mandatory 1st quarter next year, if these dates are accurate for module implementation, the medical device industry and all associated actors, need to get into 6th gear to ensure compliance.

Please note: NO official announcement from the European Commission confirming these details is currently available.

For what purpose has the EC “leaked” this information? This situation is very similar to the original EUDAMED postponement 7 months ago when during a Medical Device Forum meeting, a cavalier announcement from a committee member caused multiple repercussions around the regulatory world. It would be a week following that single comment before any official communication was issued by the EC or MDCG.

Why is this process not transparent? Multiple rumours, unsubstantiated statements, and speculation does very little to support a smooth MDD to MDR transition for industry, competent authorities, and all key stakeholders.   

The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.

During these extremely challenging times of the COVID-19 crisis, regulatory teams are continuing to struggle uphill to support business compliance.  Do not allow a lack of technology keep you at sea level.

Please contact me at KimYoung@instem.com for additional information on software solutions for EUDAMED data.

K Young

Join our own Kim Young, along with FDAnews, on May 20th

We are excited to be sponsoring the upcoming FDANews webcast titled Sustained Medical Device Regulation Compliance: Ensure Your Regulatory Processes and Tools are Fully Optimized.

Join us on May 20th at 1:30 PM US EST to understand how to optimize your processes and tools to ensure that your regulatory operations can help get new products to the global market with improved speed, efficiency, productivity, and quality while also ensuring continued regulatory compliance and life-cycle management of your legacy device portfolio.

For more information and to register, click here.

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.