Theranos Loophole Explained

Last week, my son, a second-year university student reading microbiology, approached me very excited indeed. He had come across an article on his mobile news feed that was related to mum’s work! He asked, “This blood test described as inadequate and inaccurate, isn’t it a medical device?” Yes, I answered. “If it never worked effectively, how and why did the FDA approve it?” Son have a seat.

The new year began with the news that Elizabeth Homes, billionaire former CEO and founder of Theranos, was found guilty of wire fraud and conspiracy to commit wire fraud.

Theranos developed a diagnostic test, which the company claimed was able to perform a full range of clinical tests using very small blood samples drawn from a single finger stick.  The analyzer was publicly presented to investors, health professionals and patients with the ability to produce results that were more accurate and reliable than those yielded by conventional methods—all at a faster speed than previously possible. Brilliant, everyone said. The wealthy invested, health clinics wanted to partner and the famous were on the board of directors.

However, the criminal investigation revealed that CEO Holmes knew about accuracy and reliability problems, limitations for the number of tests performed, slow speed, and, overall, could not compete with more conventional technologies.  Evidence presented showed that Theranos’ ultimate solution was to utilize equipment bought from third parties to perform the blood testing. Certainly not the golden panacea as promised.

The term Laboratory Developed Test (LDT) is used to describe a certain class of in vitro diagnostics (IVDs) that are designed, manufactured, and used within a single laboratory, often in a hospital and are not distributed or sold to any other labs or health care facilities. Also note that any FDA-approved commercial test that is modified in any way by a testing lab is considered to be an LDT.

In the United States, LDTs are regulated under the Clinical Laboratory Improvements Amendments (CLIA) program. (For more information

LDTs are not centrally registered or tracked, therefore no one knows precisely how many are used, when and why they are used, or how their performance compares with FDA-reviewed diagnostics.

Oversight Comparison Table:

The above table illustrates a fragmented surveillance system, whereby tests are regulated according to where they are developed and used rather than their risk to patients and their outcomes.

Critics say the lack of FDA regulation is a loophole that allows laboratories to perform unproven tests with dubious claims. As per the Medical Device Amendment of 1976, LDTs were intended as limited exceptions to FDA medical device oversight as their application was to be generally low risk, short term for simple analysis.

Every year in the United States an estimated 3.3 billion in vitro diagnostic tests performed, impossible to determine how many are LDTs. Without oversight, LDTs can be high-risk and give the health care providers who rely on them inaccurate information which may potentially pose dangers to general public health via misdiagnoses.

As Theranos did not release the LDT test kit to the commercial market, the fraud remained safely under the FDA radar for many years.

“The FDA’s Office of Criminal Investigations (OCI) will continue to investigate and help bring to justice individuals and companies responsible for putting the public health at risk,” said FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen in relation to the Theranos case.

In 2010, the FDA announced its intent to reconsider its policy of enforcement discretion for LDTs. But not much regulatory progress has been made since publication of an FDA discussion paper on 13 January 2017. The efforts to pass any stringent legislation has stalled and the fate of LDT regulation has met with opposition from various political and healthcare fractions and appears to have an uncertain future under the current administration.

So, darling son, the FDA did not approve the Theranos blood testing regime because current legislation does not require FDA review.

Next week: How IVDR legislation may close this legislative gap for the European market.

K Young


Black Friday

Why is your regulatory data stored in regional silos?

Why is there a requirement for inter-departmental data requests?

Why does it take 3 days, 3 weeks, 3 months to find what you are looking for?

Why must the regulatory team triple check spreadsheets for data accuracy?

Why are weekly registration update meetings scheduled throughout your diary?

  • Data secreted into limited access, regional silos supports the notion that only those personnel in the region “understands” the data, knows where the data is located, and whether or not it is accurate. This is not an efficient or sustainable process, which may actually increase internal expenditures.
  • Whenever regulatory staff move on, you immediately lose access to your data history. Resource, already drained, is now allocated to rebuilding the historical knowledge back into those antiquated spreadsheets to repeat the cycle.
  • Take into consideration and analyse the value return on the salary earned by regulatory professionals performing rote administrative tasks. Automation definitely converts into the least expensive alternative.
  • You have designed your medical devices to provide life-enhancing products for patients across many years, data compliance is not an option.
  • When your organisation successfully maintains one Single-Place-of-TruthTM for your regulatory information, your limited resources are allocated to more value-added activities with the potential to increase revenue.

The speed in which medical device legislation is evolving is unprecedented. The challenges for regulatory compliance activities are further amplified due to the lack of globally harmonized efforts. The role of the regulatory professional in this new and complex data driven environment becomes even more critical.  Take the time to perform lessons learned in order to drill down to discover the legitimate causes of missed submission targets and renewal deadlines, miscommunications with health authorities and regulatory staff turnover.

How can you continue to expect regulatory teams be responsible and accountable when they are unsure, uncertain, unaware and unsupported?

The realization of your innovative product development and continuation of a successful revenue stream depends on the competency of your global and regional regulatory teams. Are you sure your RA teams have all the necessary tools at their disposal?

Let’s talk.

K Young

Photo by Tamanna Rumee on Unsplash

Eye of the MDR Storm

It feels very quiet in the medical device world. The quiet makes me ponder how all concerned parties (and there are many) are managing MDR compliance activities. It is not possible for all medical device products on the EU market to have a MDD certificate valid until 2024, therefore there must be a beehive of activity.

Across social media, regulatory associations and the World-Wide-Web, there remain promotions for a variety of free and fee-paid webinars, training sessions and consultative advice on how to interpret and interact within and around the regulation. A ground-breaking regulation that has been in effect for four years and in application of compliance for the past three months.

The European Commission, together with the Medical Device Coordination Group, continue to drip feed guidance to the medical device industry in an apparent act to convey what they actually meant when the regulation was written. No one outside the EC knows when a newly published guidance will require a 180 degree turnaround from their fundamental, resource intensive, costly and target driven plans.

However; the following predictions for an apocalyptic melt down of the medical device industry has not (yet) come to fruition:

  • Multiple device manufacturers closing up shop
  • Critical life-saving products snatched from the hands of EU healthcare professionals thus risking patient health
  • Products removed from the marketplace due to expiring certification and not enough notified bodies for conformity assessments
  • Number of importers decreasing and costs rising due to increased liabilities
  • Transferring initial registration targets to the US, thus stifling product innovation within Europe and depriving the EU population of new state of the art devices
  • And of course, one must mention Brexit, GB and Northern Ireland….

The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available in September 2021 (except for the mechanism for scrutiny and the clinical evaluation consultation procedure functionalities). Based upon roll out of the actor module, activation of the second and third modules is not anticipated to go very smoothly.

Were these doomsday prophecies falsely promoted by hand-wringing pessimists or are they yet to materialise to wreak havoc?

If you have an opinion to share on the state of play for the MDR or other legislation, I would love to hear from you.

For those of you who remain unsure as how to manage the globally required increase in data management efficiencies, regulatory operational support for compliance is just a click away at

Do not get swept away in silence, we are here to assist you and provide a warm and welcoming shelter from the storm.

K Young

Actor ID v SRN

The actor module for EUDAMED was released live on 01 December 2020. In advance of this date, the European Commission (EC) provided the medical device industry with a 60 page Actor Registration Guide illustrating the required data entry methodology. Since December, the EC and Medical Device Coordination Group (MDCG) have issued various FAQs, position papers and infographics to further explain the functionality and define terms necessary for those economic operators obligated to upload data into the EUDAMED system.

Seven months after the actor module deployment (and 18 months following the original date of full EUDAMED deployment) the medical device industry remains confused. Our friends at the MDCG have posted guidance MDCG 2021-13 rev.1 July 2021 in the effort to deliver additional clarification on the obligations and rules for the registration in EUDAMED, in this instance, for the “other” actors.

Actor ID: is the identifier issued to all actors registered in EUDAMED for their identification in the system. It will be automatically generated by EUDAMED and issued once the registration request is approved by the relevant competent authority.

SRN: is the Single Registration Number that is issued through EUDAMED to manufacturers, authorised representatives and importers by the competent authority.

The actor registration request for any manufacturer, authorised representative, importer or a system/procedure pack producer must be verified and approved by a competent authority.

It must be noted, if an actor entity subsequently takes on the role and obligations of a manufacturer, Authorised Representative or importer of a non-custom-made MDR device, the Actor ID will then be considered as an SRN.

System and Procedure Pack Producers (SPPP)

Before placing a system or procedure pack on the market, the legal person responsible has an obligation to assign a Basic UDI-DI to be provided to the UDI database. In order to fulfil this obligation and before placing the system or procedure pack on the market, the SPPP must be registered in EUDAMED (deadline 6 months after notice of full EUDAMED functionality). Registered SPPPs are assigned an Actor ID.

The continued ambiguity, for what should be a straight-forward process data entry for the actor registration module, does not bode well for a smooth roll out for the remaining EUDAMED modules.

We trust many more clarification documents for EUDAMED and MDR compliance will be forthcoming from the EC Commission and Medical Device Coordination Group to support industry’s drive to retain and obtain the marketing status of life-enhancing devices for the European population.

Please feel free to contact me if you have any additional questions – I am available to help

K Young


MDCG 2021-13 rev.1

MDCG Endorsed Documents and Guidance

Actor Roles Infographic

Actor Module FAQs

Legacy Device Challenges

Ok, so 26 May 2021 has come and gone. To date, no horsemen of the apocalypse or world annihilating meteor strike has befallen the medical device industry. However, the continued management of MDD legacy device data is an altogether different cataclysm.

According to the European Commission (EC), Legacy Devices are defined as         Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).                 It must be noted that this definition DOES NOT apply to Class I devices that are not sterile or with a measuring function as these devices did not require notified body certification.

As Class I sterile and those Class I with a measuring function are not considered legacy devices, application of a transition period does not apply and therefore immediate and complete MDR compliance is necessary for continued marketing.

Legacy devices with applicable directive certification may legally remain on the European market until:

  • The device undergoes a significant change in design or intended use thus requiring compliance to MDR legislation; or
  • 26 May 2024 provided no significant changes and the MDD/AIMDD/IVDD certificate remains valid

Legacy devices must be registered in EUDAMED if:

  • A post-market surveillance and/or a vigilance report ensues; or
  • By the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED

Eighteen months ago, the EC issued guidance to describe how legacy devices will be identified in EUDAMED without entering the MDR obligatory Basic UDI.

An identification element EUDAMED DI (the equivalent of the Basic UDI-DI) will be required. The EUDAMED ID will be automatically and fully generated by EUDAMED from the EUDAMED DI, in case a UDI-DI is not assigned to the device. The EUDAMED ID corresponds to the UDI-DI. The EUDAMED ID is a virtual Device Identifier. It exists to keep the structure and format homogeneous for the registration of devices in EUDAMED. It is not applied on labels. The Legacy Device will therefore have the following identification elements: a EUDAMED DI (generated based on the UDI-DI) and a UDI-DI (assigned by the manufacturer). Easily understood??

For those medical device companies waiting until the last possible moment to implement an approach for MDR compliance for their 1000s of legacy devices (for example; CE certificate expiry in 2 years or no changes planned) remember you must be fully prepared for any EUDAMED post-market surveillance and/or a vigilance reporting activity. Once EUDAMED goes live, all medical device serious incidents must be captured in the database, legacy or MDR certified.

Regulatory affairs teams, and those responsible for EUDAMED data transmission, will need to be included in the post-market surveillance team process to guarantee that the applicable data is collected and transmitted within the appropriate timeframes. Failure transmit the data in a timely manner risks non-compliance.

The date of application has passed. The medical device industry did not spontaneously implode. However, do not become complacent when executing the mandatory, on-going and resource intensive activities essential to keep life enhancing products on the European market.

Supporting your regulatory affairs teams by providing the appropriate data capture tools before MDR compliance crunch time, will ensure greater a efficiency, increase in consistency and a significant reduction in human errors.

More to come…

K Young


MDR: New Beginning

The beginning is the most important part of the work” – Plato

Exhale. The regulatory affairs team has successfully managed to bring the required portfolio data into a state of compliance to meet the portentous date, 26 May 2021. Surely the cross-functional teams and key stakeholders have celebrated the end of the programme and are now ready to move on to the next business target.

Stop, right, there.

The difficult work is just starting. The act of maintaining MDR compliance now represents one of the biggest challenges for Medical Device companies entering or continuing business in the European market. Survival dictates establishment of a sustainable MDR continuation plan for successful and long-term business stability.

Maintaining company awareness that compliance to the MDR “is not just for Christmas” is critical.

Preparation for a stable continuity plan entails bringing together internal and external stakeholders across the entire device supply chain to ensure the correct communications and data infrastructure are utilised. Regulatory affairs teams will need to implement effective delivery methods for continued company-wide information exchanges and to track on-going progress and processes. The usual workarounds and patchy gap filling process will eventually become not fit for purpose.

As with most change, compliance to MDR will cause major disruptions, possibly cause significant increases in internal spending, resulting in a possible reduction in product revenue potential and reduce availability of investments in R&D. Senior management decision makers must allow regulatory affairs teams to engage in approaches to minimise the possible negative effects attributed to conformity to the regulations.

MDR is pushing medical device companies, their regulatory teams and supply chain partners to actively embrace integrated solutions for effective data access, visibility, management and governance. Innovative digital technologies can support the newly implemented regulatory requirements for increased data volume and speed of data transmission whilst maintaining data integrity. When software solutions are implemented, costs are decreased as regulatory professionals are able to apply their skills and knowledge to developing regulatory strategy and other significant value-adding activities rather than completing rote data administrative tasks.

MDR has shifted the legislative enforcement spotlight from approvals to encompassing the entire medical device life-cycle management as a means to engender increased device safety, effectiveness and transparency throughout the European medical device market. Integrated solutions will support industry in meeting those requirements for greater transparency, identification, traceability though to continuous postmarket surveillance.

It is clear from monitoring the association websites, guidelines, conferences and social media, that all European medical device industry players — manufacturers, NBs, PRRCs, ARs, importers, distributors— must invest heavily in their respective application of the new regulations, or risk considerable financial and competitive losses.

“The secret to change is to focus all of your energy, not on fighting the old, but on building the new.” -Socrates

K Young

EUDAMED Alternative Solutions

Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2021-1 Rev.1

The objective of the guidance is to describe the harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional, anticipated for 26 May 2022. The proposed solutions aim to allow all relevant parties to meet their applicable MDR obligations whilst minimising additional burdens.

To remind you, the intended purpose of the EUDAMED modules is to: facilitate the collation and processing of information under the MDR regarding the registration of relevant economic operators, devices and systems and procedure packs (UDI), notified bodies & certificates, certain aspects of conformity assessment, clinical investigations, vigilance and market surveillance as well as post-market surveillance.

MDCG 2021-1 Rev.1 changes
Third paragraph, sentence deleted: “Parties should also note that, in principle and unless otherwise concluded by the MDCG, the reporting obligations with regard to EUDAMED apply to all information generated and collected under the MDR from its date of application (e.g. UDI, certificates) and therefore must be carried out as soon as EUDAMED becomes fully functional”

▪ Manufacturers should be well aware that the obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 (Art. 27(3) MDR). Labelling requirements will apply gradually, starting from 26 May 2021 (Art. 123(3)(f) MDR).

Compliance with this obligation requires manufacturers to assign, capture and store UDI information until the requisite module is capable of accepting the data.

▪ As the functionality is available in Eudamed, the system may now be used for the registration of manufacturers, authorised representatives and importers before the notice of full functionality of Eudamed has been published. Nevertheless, EU economic operators should refer to the national provisions in Member States. Readers of this guidance are requested to refer to MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.

There has been mention in various regulatory channels, of an awareness of individual member states/competent authorities requesting information above and beyond what would be required for the Eudamed database registration. And, even worse, not responding to the requisite actions, ie. confirmation of SRN numbers.

Manufacturers certainly do not need additional burdens. Why isn’t consistency the aim of the game?

▪ Manufacturers should report serious incidents and field safety corrective actions to the respective/relevant national vigilance systems. The new MIR form has been adapted to MDR requirements and should be used accordingly or manufacturers may use the current FSCA form with the additional information required under the MDR added to the general comments section of the form.

So which form will your company use?

The guidance makes reference to CircaBC as alternative solution for the relevant parties who should endeavour to make use of already existing CircaBC directories to the extent that this is possible and appropriate.

Example of the types of activities and data to be collected in the alternative directories until EUDAMED is functional:
Nomination list of experts for joint assessment of applicationsCommission
Monitoring and re-assessment of notified bodiesMember States
Inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body’s decision regarding the conformity assessment.Notified Bodies
Clinical evaluation consultation procedure for certain class III and class IIb devicesNotified Bodies
Communicating analysis of SIs and FSCAs  Commission and Member States            
The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authoritiesCompetent Authorities

Due to the unavailability of EUDAMED, the commission, member states, notified bodies and competent authorities will be required to manage separate (confidential) directories to store and share your company data.

EUDAMED was due to become the panacea for all things related to the safety of medical devices in the European market. It is woefully inadequate (and unacceptable) that all relevant parties are subject to and are required to implement “work arounds” due to the continued delays.  

Data stored and managed in various, disparate systems, is not a great start for the application of a new regulation.

Let’s hope, this time next year we will be praising the commission for a job finally done.

K Young


Photo by Brett Jordan on Unsplash

Class I MDR Compliance

The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices. Whilst the guidance is most welcome, and industry is humbly grateful, this publication now appears when the regulation goes into effect 28 Days Later (yes, reference to the zombie apocalypse film). Better late than never?

The EC factsheet provides clarity buried on page 3 item 2:

2. When do MDD Class I medical devices that remain as Class I under the MDR need to meet the requirements of the MDR?

Class I medical devices placed on the market under the MDD, that continue to be Class I under the MDR, will need to comply with MDR requirements as of 26 May 2021.

All Class I medical devices destined for the European market are required to guarantee compliance with all applicable requirements of MDR 2017/745 as of 26 May 2021. If a manufacturer of a Class I device (as per MDR classifications) already placed on the market was patiently waiting for this additional guidance prior to implementing internal processes, well it is a bit too late. European patients, hospitals, and healthcare workers should trust that astute regulatory teams have performed well within their organisations to facilitate these devices remaining available to provide foundational treatment and also to support life-enhancing therapies.

Since 2017, medical device manufacturer’s cross functional teams have been struggling to decipher the requirements, implement new processes, review/update documentation and source electronic tools, all essential to support continued regulatory compliance with MDR.

Compliance with the regulation for Class I medical devices will entail much more data exchange and collaboration between internal functions, external supply chain actors and regulatory authorities, with increasing volume and velocity. Device data, the company’s most valuable asset, needs special handling, care and security. Regulatory operations teams who have successfully manoeuvred through the myriad of requirements, should not be let down, so close to the finish line, by a lack of tools for data governance and management. Compliance with the MDR must be viewed by senior management as the opportunity to enhance capabilities of regulatory affairs which promotes a sustainable and scalable organisation.

Ensure your regulatory affairs operations have the support they need to keep Class I medical devices on the market.

K Young


EC Factsheet for Class I Medical Devices:

MedBoard LinkedIn Post:

Photo by Brandi Redd on Unsplash

Importers – Strategic Partners

Importers – Strategic Partners

According to multiple regulations, importers of medical devices into the European marketing space must co-operate with the product manufacturers and authorised representatives to achieve an appropriate level of traceability of the devices they manage. Each economic operator connected in a medical device supply chain shall be able to check compliance of all the others involved.


Importers are responsible for making sure that the devices they place on the market

  • bear CE marking,
  • are accompanied by any required information,
  • are labelled in accordance with the regulations,
  • have been assigned a UDI where applicable,
  • are registered in EUDAMED


  • If an importer considers a device is not compliant with the regulations, the importer shall not place the device on the market and the importer shall inform the manufacturer and the authorised representative of this action
  • The importer should also inform the authorities if they suspect that a device is counterfeit
  • The importer should inform the competent authority if the device poses a serious risk to public health


Importers shall indicate on the device or its packaging, or in a document accompanying the device,

  • name, registered trade name or registered trademark,
  • registered place of business,
  • contact address


Importers have the responsibility to inform manufacturers and their authorised representatives in the event of complaints and escalate matters of non-compliance to the authorities

They should keep a catalogue of

  • complaints,
  • non-conforming devices,
  • recalls,
  • withdrawals from market

Importers are required to cooperate with authorities to provide device samples or grant access to the devices within their purview.

Device Handling

Importers should ensure that the storage and transport conditions do not jeopardise a device’s compliance according to the manufacturer’s instructions.

Medical Device Manufacturers

Manufacturers must be able to demonstrate control and monitoring of economic operators within the entire supply chain, which can be a regulatory compliance challenge during an audit.  This may be successfully accomplished by delineating all new responsibilities for distributors, importers, assemblers, and authorized representatives. Importers and manufacturers should pay particular attention to this issue when formulating contractual agreements.

Importers cannot execute their responsibilities unless the legal manufacturers enables them to do so by supplying the necessary documents and accurate information. Secure electronic database and data exchange solutions, on both sides, are required to ensure the correct data is transmitted to the correct entity in the correct timeframe and stored appropriately.

Manufacturers should realise championing their importers to comply with the myriad of regulations encourages the building of a strategic partnership which supports a stronger supply chain.

Medical device manufacturers must provide regulatory teams with the tools and resources to ensure smooth and compliant interactions with their linked economic operators as supply chain partners rather than third-party service providers.

K Young


EU Commission Blue Guide 2016 (updates currently in draft)

EU Importer/Distributor Fact Sheet

Photo: Photo by Pat Whelen on Unsplash

Authorised Representatives: Effective Collaboration Required

Are you a global medical device organisation without a physical location in Europe? Of course, you are aware of the medical device regulation MDR 2017/745 mandatory requirement to appoint an EU Authorised Representative [(AR) or (EC REP)] to represent your company to the European competent authorities. Remember, this legal obligation is applicable 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, you risk interruption to your supply chain.

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 specific 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.

What are an AR’s specific legal obligations which require effective collaboration?

As per MDR 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 (DoC) and technical documentation (TF) have been prepared and,
  • when applicable, that an appropriate conformity assessment procedure has been performed by the manufacturer;
  • The AR must keep available a copy of the TF, 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 device family as specified and all updates for 10+ (or 15+) years, including the ability to produce the current version as and when requested by the competent authorities. The AR must fulfil and perform these activities for all device classes, as applicable.

  • 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 to the perform documentation assessments and verifications.

  • 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 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

The mandate should include methods of communication and information exchange according to your internal procedures and timeliness of appropriate actions.

  • The AR must immediately inform the manufacturer about complaints from healthcare professionals, patients and end users about suspected incidents related to a device for which they have been designated

The AR and manufacturer will need secure processes and systems for monitoring, capturing, analysing and exchanging complaints data.

Suppose there is a need for a change of authorised representative for a device family. During the transition period, your organisation must communicate and exchange information with both the outgoing and the new authorised representative (MDR Article 12).

Are Authorised Representatives Audited?

The Competent Authority may 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.

The AR will dictate and manage your relationship as legal manufacturer, including specified liabilities, with the competent authorities.

  1. Are you ready to begin communicating with and sharing your most valuable company asset, technical file documentation, as obligatory for the next 10 -15+ years for each device?
  2. Can your regulatory information management system effectively and securely comply with the required 3rd party data exchange?
  3. Have you upgraded your procedures to incorporate these additional communication and data exchange actions, including staff training?
  4. Do you have senior management and key stakeholder commitment for supporting these new collaborative commitment activities?

Regulatory professionals, please engage with your internal cross-functional teams, you are the experts in creating the appropriate MDR strategy. Do not let a lack of organisational understanding of the vital importance of the AR collaboration activities negatively impact MDR compliance and therefore successful management of your medical device supply chain.

Next time: Importers

K Young


Factsheet for ARs, importers and distributors:

MDR overview:

Actor registration module:

Actor roles:

Photo by Paweł Czerwiński on Unsplash