For those regulatory professionals who thought the UDI quagmire was sorted, have you thought about the unique identification requirements as legislated by Peoples Republic of China via the NMPA? On 10 August 2020 the NMPA launched Unique Device Identification (UDI) Database on its website.
From 01 January 2021 (43 days from blog posting date)
the first group of 64 Class III medical devices shall have unique identifiers
Please be aware, even though only 50 data attributes are necessary for submission to the China UDID database, less than US FDA and significantly less than under MDR, 30% of these attributes are UNIQUE for China UDI. Thus, yet another set of regulatory data to capture and maintain.
It really took a bit of trolling through the internet to finally find a complete list (in English) of the 64 devices assigned for the first phase of UDI implementation (It would appear that access to English translations of the 64 product names are carefully shrouded in unobtainability ):
The Chinese medical device and in vitro diagnostic market is growing substantially. When conceiving and articulating your global regulatory strategy, the requirements for global UDI demand to be at the forefront for accurate decision making. Regulatory professionals, ensure that senior management understands your operational workflow constraints and prerequisites for capturing, maintaining, accessing, amending and transmitting global UDI data necessary for maintaining compliance and therefore marketability. Compliance translates into revenue and patient satisfaction.
As always, please refer to the original NMPA data sources for confirmation of requirements as translations may be inaccurate.
If your organisation does not have a physical location in Europe, you are required, by the medical device regulation MDR 2017/745, to appoint an EU Authorised Representative (AR) or (EC REP) to represent your company to the European authorities. You must retain an AR for as long as you market your medical device in Europe. This legal obligation is effective for the marketing of all classes of medical devices, whether or not a notified body is required for CE marking. If you do not appoint a representative, your products destined for the EU market may be stopped at the border.
Who is the AR?
An AR is any natural or legal entity established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s legal obligations under the Regulations for particular device families. (A manufacturer may have more than one authorised representative!)
What is the written mandate?
The mandate is the agreement document signed by the authorised representative and the manufacturer declaring the specific tasks to be performed by the AR on behalf of the manufacturer. The Authorised Representative will assume and share appreciably more risk and liability than currently assigned under the medical device directive. The MDR stipulates a list of minimum requirements for mandate declaration and agreement.
What are an AR’s specific legal obligations according to the regulation?
As per Article 11 (3), the agreed mandate shall require, and the manufacturer shall enable, the authorised representative to perform the following minimum tasks in relation to the devices that it embodies:
The AR must verify that the EU declaration of conformity and technical documentation have been prepared and, when applicable, that an appropriate conformity assessment procedure has been performed by the manufacturer;
This task requires the AR is allowed access to the manufacturers DoC andTFs for the device family as specified and has the applicable expertise to determine compliance
The AR must keep available a copy of the technical documentation, the EU DoC and, if applicable, maintain a copy of the relevant certificate, including any amendments and supplements, issued according to Article 56 (Certificates of Conformity), at the disposal of competent authorities (CA) for the period of 10 years (15 years for implantables) after the last device has been placed on the market
The manufacturer must enable access for the AR to the current DoC, TF and certificates of conformity for the devices specified and all updates for up to 15 years, including the ability to produce the current version when requested by the CA.
The AR must register with EUDAMED prior to a conformity assessment requiring notified body involvement and verify that the manufacturer has complied with the EUDAMED registration obligations for UDI for all device classes
The AR, when requested, must provide the CA with all the information and documentation necessary to demonstrate the conformity of a device, in the official language determined by the Member State
The mandate should specify who is responsible for obtaining and updating the translated conformity documentation and how the AR will be allowed access
The AR is required to forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
The mandate should include methods of communication and timeliness of appropriate actions
The AR must cooperate with the competent authorities on any corrective or preventative action taken to eliminate or, mitigate the risks posed by the devices for which they are responsible
As the AR will be held jointly and separately liable for defective medical devices, one can assume that an AR will be monitoring a manufacturers compliance very thoroughly and insistent on complete cooperation with CAs
The AR must immediately inform the manufacturer about complaints from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated
The AR and manufacturer will need processes and systems for monitoring, capturing, analysing and exchanging complaints data
The AR is obligated to terminate the mandate if the manufacturer acts contrary to its legal obligations as per the Regulation.
The change of authorised representative requires an agreement that defines the arrangements between the manufacturer and both the outgoing and the new authorised representative (Article 12). Changing an AR may be costly as the AR details are included in the labelling.
Be mindful that Article 11(4) also specifies the tasks that a manufacturer cannot delegate via the mandate agreement to their AR. This includes requirements related to the device design, QMS system, clinical evaluation, writing technical documentation and labelling; as these are the individual responsibilities of the manufacturer.
Does having an Authorised Representative impact labelling? The manufacturer must include the name and address of the AR on the product label, outer packaging and/or Instructions for Use. This information of the AR should be shown next to the official logo.
Are Authorised Representatives Audited?
The Competent Authority can audit an AR at any time, including unannounced, to determine if they understand their role, have direct access to the manufacturers documentation and have systems in place to ensure fulfilment of its role according to their mandate.
What about Brexit?
Following the UK’s departure from the European Union, anyone based outside the United Kingdom (EU or non-EU) will require a UK-based responsible person to act on behalf of the manufacturer to initiate or continue selling in the UK. This includes registering with the MHRA before the device is placed on the UK market. Furthermore, UK-based companies will require an EU-based AR, as illustrated above, to initiate or continue selling in the EU.
Non-European Medical Device Manufacturers:
Your choice for authorised representative is critical for initiating and/or continuing the successful marketing of your devices within the European community.
Your AR will dictate and manage your relationship with the competent authorities.
Your appointed AR must be willing and capable to share and administer legal obligations under the Regulation to support your products.
Are you ready to begin communicating with and sharing your technical documentation as obligatory for the next 10 -15 years?
Within each regional UDI system (Unique Device Identification), manufacturers are legally obliged to identify and register their medical devices. It all instances, this is not just about receiving a single UDI code, and recording what was submitted and to which authority, but requires the collection, management and submission of perhaps a hundred odd data elements in addition to the UDI code. A fact often overlooked and underappreciated.
Meeting these complicated and variable needs for each health authority’s “unique” device identification requirement in a global environment is an arduous task. UDI data compliance adds an additional layer of complexity to an already resource stretched team. Managing the regulatory data across regions, languages, timezones and facilities without a robust and efficient process is not sustainable. Non-compliance is not an option.
As always, please free to contact me with blog comments or suggestions for future post topics. I appreciate all feedback 🙂
The topics for discussion serve as a stark reminder that our medical device industry remains inadequately prepared for application of the MDR and IVDR regulations. For example:
Path to Compliance: Industry EU MDR
EUDAMED update: Status and Future Timelines of Implementation of the EUDAMED Database
Strategies to Manage your Distributor Regulatory Risk
Meeting the New PMS Reporting Requirements of MDR & IVDR with Future-Proof Systems
Granted, I understand that 2020 has been a challenging, arduous and hellacious year but it appears, based upon some of the audience questions, that there are organisations who have not yet begun considering how they will implement actions to ensure compliance.
If an organisation is still asking basic questions today, at 233 days (5352 hours) until application of MDR, when will they actually be prepared??
I would really like someone to explain to me, just what is the problem with preparedness??
Is it a lack of understanding or awareness of the requirements?
Who lacks the understanding?
How do we get them to understand?
Is it a lack of resources?
How to approve the funding allocations?
Do they think application will be delayed again, therefore have even more time?
Wishing for another crisis? I hope not.
This lack of readiness does not bode well for the future of the European medical device market from 2021. Well at least in the immediate future.
Will those companies who are “ready” dominate the EU market?
Will the smaller SMEs disappear altogether?
What will happen to product availability?
I know that I have asked a lot of questions. If anyone has the answers, I would love to hear from you.
European Regulatory requirements1 DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether:
the device has the (CE) mark and an EU Declaration of Conformity has been issued;
the importer’s name is affixed on each device or is in the attached documentation (where applicable);
the device bears a unique device identifier assigned by the manufacturer (where applicable);
the device is labelled properly and has instructions for use (IFUs) in an official language of the country in which it will be marketed
In addition, distributors are responsible for:2,3
ensuring storage and transportation of devices under appropriate conditions as defined by the manufacturer; and
notifying the manufacturer and competent authorities when they suspect a device has been falsified or presents a serious risk to patient health
These are the facts.
A question for medical device and IVD distributors: How will you ensure compliance?
As the regulatory operations teams working for medical device and IVD manufacturers are struggling to manage the myriad of internal MDR/IVDR data requirements,
Who in your organisation is managing and supporting all of your economic operators to ensure no disruption to your supply chain and revenue stream?
Are you assuming your distributors have got it covered as it is their responsibility?
Can you even link your economic operators to a specific device or even device family?
How will you exchange the necessary data between yourselves and your disparate distribution chain?
For those of you who cannot confidently answer these questions, I suggest giving me a call.
How many of you have initiated contact with someone you haven’t met (in person) as you struggled to answer a challenging internal query? During this period of lockdown and working from home, I have found myself reaching for my contact lists, both internal and external, more often than in previous months. Sitting alone in one’s home office, bereft of professional human contact (pets, children and the postie doesn’t count), I find it is much easier to pick up my mobile phone, submit a Teams meeting request, or send an email in order to collaborate.
All of us, regardless of professional status, require help or assistance from time to time. One shouldn’t shy away from reaching out to a friend, colleague, acquaintance when in need of an authoritative opinion or advice of a specialist expert.
Sometimes it is difficult to acknowledge expertise in areas with which we are unfamiliar. There are those that know a little about a lot of things and others who know a lot about a niche subject matter. Organisations do try to fill roles with individuals on both sides of the spectrum. Difficult as it may seem to acknowledge, no one knows everything! Your fellow team members are just that – part of your team.
Utilising a closed collaborative system expects an organisation to develop and grow competitively in the long term; whilst commercialising new products and services within a protected boundary. Copyrighted collateral, intellectual property and innovative ideas are thus protected. This approach may work for some. Openness to utilising external resources and ideas throughout a functional process development, such as an MDR gap analysis review, allows a team to explore and possibly build new capabilities.
External collaboration might be as simple as colleagues exchanging ideas over a coffee (with social distancing of course) or as formal as zoom meeting with a prescribed agenda.
No incentives or motivation
Limited resources (time, funds, people)
The Covid-19 lockdown, with its seemingly draconian policies and regulations, has provided a stark example of how it really is better if we work together.
There are concepts, facts or ideas I may know, that you may not be aware. I could possibly support resolution of one of your challenging activities. Please reach out, even if just to chat. No obligation.
Apologies to everyone for the lack of RIMtelligence blog traffic over the last few weeks.
The need for quality, family holiday time, superseded my weekly and ever scintillating blog writing. Even with all of the various restrictions, the holiday was absolutely fantastic, (in spite of my breaking one toe on each foot the day before travel), especially as self-isolation was not compulsory upon our return.
My arrival home, at 03.35 Sunday morning, was immediately followed by attendance at the 2020 annual #RAPSConvergence. I have to say, the virtual approach to this years conference created a very different atmosphere for session participation, solution provider engagement and overall networking opportunities. I would be interested in reader opinions, both positive and negative of the RAPS affair.
Virtual webinars are proliferating at an amazing rate. Please join me on Wednesday 30th September for an informative 60 minutes: https://lnkd.in/dk4Pp9P
During this webinar, I will discuss the less considered yet critical topic of how managing Global UDI data requirements directly impacts the multiple medical device industry stakeholders (manufacturers, healthcare providers, competent authorities and patients) and approaches considered across industry for organisational system implementation. UDI compliance requires the right regulatory operational strategy to ensure an increase in efficiencies and at a lower cost. Our key objective is to enable those in senior decision making roles to make informed choices as to which methods best suits internal regulatory processes, product portfolio and market requirements.
A Regulatory professional’s role in the life-science industry demands a special adherence to a code of ethics.
Dignity and Respect
Our employers, employees, peers, and all external parties with whom we interact, not only expect compliance with these ethical codes, but also rely on our competent guidance to support the life-cycle management of life-enhancing medicinal products. This reliance is based upon the knowledge that regulatory processes are developed and implemented with this aim in mind.
“the quality of being able to be trusted or believed because of working or behaving well”
Regulatory reliability is critical in today’s evolving and demanding regulatory environment. As per the above, reliability is realised only when one is working or behaving well. A well-resourced, focused, and a highly regarded regulatory team with the proper executive leadership can be an effective way for an organisation to support “working well”. This team is fundamentally no different than any other risk averse discipline that requires targeted investment.
Unfortunately, without examining all causes, organisations often fault the regulatory professional when reliability suffers a decline. Facilitation of a forward-looking investment approach is de rigueur to achieve the highest level of regulatory reliability, essential for your organisation.
Please ensure that your regulatory teams are supplied with the correct tools and resources to execute their multiple responsibilities.
Safeguarding regulatory reliability will equal organisational success.
August is holiday season for the northern hemisphere regions. Those of you down “under” (Santiago, Cape Town, Sydney, Christchurch) are hopefully enjoying a lovely winter. 😊
Summer holidays in the UK are a very much anticipated annual ritual. Whether one spends the holiday time pootling around the garden, sightseeing locally, visiting friends and family or yachting across the Atlantic, time away from daily work tasks (even when working from home!) is necessary to recharge mentally and physically. The worldwide travel advisories due to the Covid-19 crisis have made for a difficult and frustrating time for those of us who wish to holiday abroad.
As such, I have found myself, over the past few weeks, dealing with a significant magnitude of data information entry:
Data entry for multiple refund requests for cancelled holidays
Submitting personal track/trace details to destination governments x 2
Submitting personal track/trace details to UK government for return arrival
Data entry for new groups of 10 and 6 persons for separate trips
Keeping track of all the various reservation numbers – new and cancelled
Keeping track of the refunds received
Yes, at one point thought I would require an excel spreadsheet to track all of the changes…..
The process was fraught with challenges and of course, human beings invariably make mistakes:
Clicked wrong button during refund requests which lead to multiple phone queries to update status
Destination government forms were unwieldy, difficult to understand, unclear where the individual data points were to be captured, all undertaken without clear guidance
Spelled my husband’s name incorrectly (LOL) thankfully discovered prior to boarding pass issue
Needed to double and triple check each “numbered” entry such as birthdates and passport details from the individual source documents
I am a regular user of on-line forms and databases. I can image how those individuals not familiar with such processes would struggle to complete each field accurately.
Is the data saved whenever I move to the next page?
Can I go back and change the information?
Why am I getting an error message?
Why do I have to re-enter the same data every time?
Did the form save correctly?
Will I be charged for a mistake?
I don’t understand what data the field is requesting
If the form is incorrect will I be denied entry at my destination?
The holiday data entry requirements were laborious due to its manual process, coupled with the nonintuitive nature of the form designs. For those non-Regulatory Affairs personnel in the medical device industry who are performing these same input tasks in relation to their holiday travels, try to imagine multiplying those data management requirements by 10xx as appropriate per 1000’s of device product codes.
Misspelling my husband’s name for the holiday flight could have cost me £50. Misspelling and incorrect data entry for your medical device information will certainly cost your firm much more.
Behind every regulatory operations workflow, registration submission, health authority interaction, there lies data ripe for analysis. This data is probably one of the most important resources a life science organisation can possess. Utilising analysis of this regulatory data can help drive change with positive outcomes to support increases in efficiency and revenue generation. There is a wealth of information available to your organisation if you are ready to embrace it.
It is vital for every regulatory strategic plan and decision to be grounded in solid data. Data analytics can provide you with key insights that help you make the best choices in the ever-evolving regulatory environment. Analysis of this data supports the regulatory team in:
the development of a clear idea of the right road to achieving targeted business goals
what is happening in real time with regulatory submissions
establishing the next steps to remain competitive
Set Realistic Goals
Setting goals for your regulatory submissions sometimes involves educated guesswork without the right information. Submission goals should not be a moving target. Using analytics, you will be able to assemble data from historic trends and previous regulatory interactions, enabling the team to have a clear idea of what the goals should and can be, right from the project initiation. This ensures that you do not miss opportunities to obtain faster approvals and thus achieving a revenue generating marketing status. Review of the analytics supports a transparent understanding of when achievement of certain described goals are not possible. Analysis may also show the weaknesses of your processes so that you can initiate timely improvement.
Regulatory affairs intuition and experience are invaluable, but some decisions that affect key business objectives ought to rely on actual data. Regulatory strategy and determination of possible registration outcomes rely on this background data. Even when it comes to resource management, actionable data can help determine how best to deploy limited resources. Organisations utilising regulatory analytics are more likely to improve their decision-making process for optimal success.
Senior management relies on the regulatory function to provide guidance for cross-functional decision making, affecting the efficiencies across the organisation. Presenting the data in a visually captivating way, making the data more interesting (wow – interesting data!) and helps to address the need for faster, accurate reviews and an agile decision turnaround.
Curtailing Regulatory Risks
Making the right decisions based upon sound data should decrease the prospect for added risks. Avoidance of unacceptable regulatory risk may be achieved in the short and long term though data analysis. Regulatory teams should no longer make the wrong decision or subject a project to increased risk due to a lack of information or inaccurate information. As we all know, failing to adequately determine regulatory risk may have catastrophic consequences in the form of field safety actions, market withdrawal or a reduction in health authority confidence.
Analytics can play a major role in decreasing the burden of regulatory costs. Measuring performance and effectiveness makes it easy to see which regulatory strategies worked and which presented sophisticated challenges. Saving time and resource in the pursuit of registration approval, key performance indicator for RA, becomes more manageable with the right data supporting decisions.
Your regulatory processes capture data unique to your company, regions, teams, and product portfolios. No one outside the organisation has access to this information. The analysis output, when combined with publicly available information, can be leveraged to increase competitive advantages. A breakdown of the past helps to draw your plans for the future.
Data analytics is the cornerstone of regulatory information management software solutions. It is now easier than ever to obtain the pertinent data and reports that will support your regulatory business decision making objectives. Imagine a dashboard tool that creates easy to read and interpret visual representations of your valuable data.