What is the MDIS platform by MedQAIR?
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
Which economic operators does MDIS support across the medical device lifecycle?
The software platform is designed to support the contracted Economic Operator, it can be used by the Legal Manufacturer to manage the downstream Economic Operators, such as the Authorised Representative, the Importer and the Distributor. Similarly, the software platform can be used to manage the upstream Economic Operators, such as an Authorised Representative or Distributor managing multiple Legal Manufacturers, and their provided Technical Documentation and or their Accompanying Documentation, such as the IFU and Product Label per Basic UDI and each consequent UDI-DI.
How does MDIS streamline post‑market surveillance and compliance?
It is developed to ensure that the technical documentation and accompanying documentation of the Legal Manufacturers is available to each Economic Operator in the medical device distribution chain. In the event of Post-Market incidents, the Economic Operators have continuous access to the latest version of the Documentation, and the system will facilitate Vigilance reporting to regulatory databases, such as EUDAMED through the IMDRF coding systems.
What types of documents can be managed in MDIS?
The software platform is designed to support an effortless upload of technical documentation and accompanying documents to facilitate quick and easy sharing across Economic Operators. The technical documentation and accompanying documents are split into separate sections to ensure that each Economic Operator only gains access to those sections relevant to their duties, for example, the Distributor will only gain access to the Labeling materials relevant to their region.
Is MDIS integrated with EUDAMED registration processes?
The software platform is designed to automate registration into regulatory databases such as EUDAMED. Once all data for EUDAMED is present, it can be pushed through the EUDAMED API towards EUDAMED, any new UDI-DI added to the system can simply upload the new UDI-DI into EUDAMED, and into future supported databases, such as GUDID and SWISSDAMED.
Can MDIS facilitate rapid device recall documentation?
If, for any need, access to documentation needs to be cancelled, the user can withdraw access. Note that there are legal obligations for Economic Operators for continued access, even when a contract with a Legal Manufacturer has been cancelled. As such information shared prior to end of contract date will continue to be accessible for the relevant Economic Operators.
How does MDIS support manufacturers specifically?
When a Legal Manufacturer makes use of MDIS, they can add their Authorised Representatives, Importers and Distributors (within and outside of the EU), share their Technical Documentation through a single portal, and update each of the Economic Operators in the event of adding or changing Basic UDI and UDI-DI details. It ensures that the Legal Manufacturer can demonstrate that they have fulfilled their duties per the medical device regulations, and provide continuous (24/7) access in a secure manner to all Economic Operators involved.
Similarly, the Legal Manufacturer can embed the use of MDIS into their QMS procedures on national product release level. For example, after a review of the local Distributor of their required duties in the system (e.g. review of Accompanying Documentation in a local language), the Distributor can ‘approve’ the documentation, so that a Legal Manufacturer can securely release their medical devices onto national markets in the EU after the CE mark has been granted. A level of national release that is often complex to manage for Legal Manufacturers, since the CE mark applies to the full European Union.
What features does MDIS provide for authorised representatives under Article 11 compliance?
When an Authorised Representative makes use of MDIS, they can document their reviews and approvals of the Technical Documentation, CE certificate, registration in EUDAMED completed by the respective Legal Manufacturers. As shown in 2024 by the Dutch healthcare inspectorate, many Authorised Representatives lack the required documented approvals of Technical Documentation and associated documents prepared by the Legal Manufacturer.
These tasks can be assigned in MDIS to the PRRC, which can be an employee of the Authorised Representative, or in the event of a micro-enterprise or SME, an external PRRC who is contracted by the Authorised Representative to perform these duties.
The use of MDIS further supports Authorised Representative to gain 24/7 access to the documentation of each of the manufacturers they are representing in their local markets. The Authorised Representative can easily create accounts for Legal Manufacturers to upload the required documentation. Similarly, these Legal Manufacturers can use the system to facilitate EUDAMED registration.
How are importers assisted in regulatory compliance via MDIS?
As an Importer of medical devices, you also share a portion of the liability of the making available of medical devices onto the market. Similar as an Authorised Representative, tasks may be assigned to the Importer, which include review of parts of the documentation and accompanying documentation. The Importer may further add its own product label to the product prior to bringing it onto the market.
Within MDIS, Importers are capable of managing the information that belongs to various Legal Manufacturers in a single software system, and ensure they stay abreast with the latest changes made by the Legal Manufacturers.
What compliance support does MDIS offer to distributors?
As a Distributor of medical devices the number of Legal Manufacturers represented could easily run into a larger group of Legal Manufacturers. More limited than the Authorised Representative and the Importer, the Distributor has fewer verification tasks assigned, and may be able to sample verification activities.
Irrespective, as a Distributor where regulatory compliance might not be at the forefront of business activities, ensuring compliance with the regulatory requirements may not be straightforward. MDIS can support Distributors in ensuring compliance with regulatory activities, such as review of accompanying documentation and review of EUDAMED registrations.
Does MDIS include automated workflows for secure document exchange?
MDIS is designed to support the verification workflows between all Economic Operators as intended by the regulatory frameworks. When using MDIS compliance is evidenced for the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor.
Even when you are an Authorised Representative and an Importer, the system allows you to fulfill both roles and evidence compliance in both roles.
How does MDIS handle document verification and validation?
The Legal Manufacturer is requested to share their Technical Documentation, Accompanying Documentation (e.g. IFU, Product Label), DOC, and potentially the CE certificate in the MDIS system. Consequently, the relevant parts of those documents are shared with the Authorised Representative, Importer and or the Distributor.
Each party can use the system and provide access to the other Economic Operators, unlocking the required verification workflows. Verification refers to the activity at the party completing the information, and validation by the Economic Operators reviewing and completing their validation activities.
Is MDIS designed with centralized and traceable database management?
Within MDIS, all Documentation, verification activities, and past revisions are stored to ensure full traceability for Basic-UDI DI’s and their UDI-DI history. Logs are stored and made available to each of the Economic Operators to ensure their actions completed are traceable and can be used to evidence compliance.
Can MDIS accommodate role-based access for different stakeholders?
As a paying customer of MDIS, there are more functionalities available. When making the system available to other Economic Operators, they will be required to complete the tasks to support the paying customer, but won’t be able to link other Economic Operators.
For example, as a Distributor, you can request a Legal Manufacturer to share their Accompanying Documentation in MDIS, yet at the same time the Legal Manufacturer cannot share the information with other Distributors, unless they become themselves customer of MDIS.
Specific user roles can be assigned to the PRRC of the Legal Manufacturer and the Authorised Representative, so that the execution of the PRRC required activities become more transparent.
What type of expert consultancy is available through MDIS?
At MedQAIR, we have a full team of regulatory experts available to support with the implementation of MDIS, and to provide generic Regulatory, Quality and Information Security support.
Which medical device regulations is MDIS aligned with (e.g., MDR, QSR, AI Act)?
The MDIS system is designed to support compliance with generic medical device distribution regulations that apply globally. It currently adds compliance with EUDAMED in specific, however other databases will be added in time.
Can users book a demo or access support directly through the MDIS page?
When visiting the MedQAIR website, users can schedule a free demo with the team of MedQAIR.
Who are the key team members behind MDIS, and what are their roles?
MedQAIR was founded by Leon Doorn, who has over 15 years of regulatory affairs experience, and Ivo Flipse, who has a similar background. MedQAIR is advised by Willibrord Driessen, who once founded Qserve Consultancy, and is a key opinion leader within regulatory compliance. Add-on, lead by Hugo Messer and Jeroen van Duffelen is further a co-founder and support with the software development of MDIS.
Why is post-market compliance becoming more complex under MDR, IVDR, and the EU AI Act?
Post-market compliance activities along the full economic operator chain have been introduced with the implementation of the new Medical Device Regulations in the European Union. Many of the activities introduced did not exist beforehand.
At the same time, the UDI requirements are new and so is the registration need within the EUDAMED System which will be enforced for medical devices in 2026.
Especially for Authorised Representatives, Importers and Distributors, the new regulatory environment adds requirements.
How have regulatory responsibilities shifted from manufacturers to all economic operators?
With the introduction of the MDR and the IVDR, the regulatory responsibilities have not shifted towards the Authorised Representative, Importer and or the Distributor, but have rather been extended. Where prior the main responsibilities resided with the Legal Manufacturer, it is now shared along the full chain of Economic Operators.
What are the major pitfalls of using traditional, decentralized data management systems for medical devices?
There are various challenges when distributing documentation over the full economic operator chain. For example, ensuring that with the release of updates (new UDI-DI’s), each of the Economic Operators receive the updated documentation that is relevant to their business.
Similar it may be challenging to ensure that all verification tasks for each of the Economic Operators along the medical device distribution are documented in a systematic and transparent manner. Additionally, EUDAMED registration may be overlooked when releasing a new UDI-DI onto the market.
The use of a system, such as MDIS can support Economic Operators such as the Legal Manufacturer, Authorised Representative, the Importer and the Distributor to complete their mandatory regulatory tasks.
Why is a centralized data platform essential for regulatory compliance in 2025 and beyond?
Regulatory requirements along the full chain are increasing, and transparency requirements are increasing. This duplicates requirements over various jurisdictions, e.g. registration in EUDAMED, GUDID, PARD, SWISSDAMED, etc, which can be simplified and labour can be reduced by managing the activities through a single platform that integrates APIs to the various regulatory databases. In the future further automation and connections are planned, such as to eQMS systems.
How does a lack of real-time documentation impact post-market surveillance?
Obviously, regulatory authorities may audit the evidence from each Economic Operators to verify compliance against regulatory requirements, which may lead to warnings and penalties.
However, the bigger risk may be associated with Legal Manufacturers bringing faulty medical devices onto the market. In such event, it is pertinent that each of the Economic Operators must be able to demonstrate that they have completed their tasks as demanded by law, to demonstrate they fulfilled their regulatory needs and have done the needed to verify the regulatory compliance of the products involved.
Failure to demonstrate such compliance may lead to liability on the end of the Authorised Representative, the Importer and or the Distributor.
What are the risks of non-compliance for EOs due to poor documentation workflows?
Each of the Economic Operators may be at risks of receiving warnings by Regulatory Authorities, penalties, and potentially in the event of patient harm liability.
How can digital solutions help economic operators collaborate effectively to meet EU regulations and beyond?
Digital solutions, such as MDIS, support Legal Manufacturers, Authorised Representatives, Importers and Distributors to make sure post-market regulatory compliance requirements of the MDR and IVDR are met.
As MDIS connects the various Economic Operators, collaboration between the parties is completely built into the system.
What post-market challenges do manufacturers face under MDR and IVDR?
The increased Documentation sharing and reviewing tasks increase the demand for each party to ensure that they review the right documentation throughout the full product lifecycle and with the release of new UDI-DI’s. Similarly, maintaining regulatory databases which often require similar information leads to unnecessary duplicate regulatory burden.
How do manufacturers struggle with managing large volumes of regulatory documentation?
Legal Manufacturers need to provide Technical Documentation, Accompanying Documentation, Declarations of Conformity and CE Certifications (where applicable) to Economic Operators, of which each requires different portions.
Keeping all these parties up-to-date, especially when releasing new UDI-DI’s may not be a straightforward and simple process, especially when bringing markets into various regulatory jurisdictions, with various requirements, various products and various Economic Operators.
Why do manufacturers need a centralized system to manage PMS, CAPA, and vigilance reports?
Having a centralised system to securely share documentation along the full Economic Operator chain facilitates transparency, and allows for Regulatory Authorities to audit compliance.
Furthermore, it supports Legal Manufacturers to obtain feedback directly from the market for their evaluation and potentially reporting to Regulatory Authorities through future EUDAMED and GUDID API’s.
How can digital platforms support manufacturers in Article 10 obligations?
The requirements set out in Article 10 cover a wide range of quality requirements, specifically those with regards to post-market compliance can partially be covered by using a system such as MDIS. Other systems such as eQMS and eTD solutions are well positioned to support with the other requirements.
How have the responsibilities of Authorised Representatives expanded under MDR Article 11?
Compared to the previous regulatory frameworks (MDD and IVDD), the Authorised Representatives have been provided with more clear instructions under the MDR and IVDR on activities which must be executed to ensure that medical devices they represent are compliance with regulatory requirements.
In addition, the role of the PRRC was non-existent under the MDR and IVDR, and demands that Authorised Representatives have in-house expertise available with regards to Quality and Regulatory Affairs.
What compliance risks do ARs face without real-time access to manufacturer documentation?
As an Authorised Representative, one can only hope that the Legal Manufacturer shares all documentation with regards to medical device releases and updates for review and ensures that Technical Documentation is made available 24/7.
As the Authorised Representative, who is not in the lead of the manufacturing and release of medical devices, the activities of the Legal Manufacturer may not always be transparent, whilst as the same time the Authorised Representative may automatically assume part of the liability for those products placed onto the market.
Why is centralized access critical for ARs to meet EU representation duties?
Specifically for Authorised Representatives having continued access to the Technical Documentation and being able to demonstrate completion of verification activities is important to ensure compliance.
The activities are critical to demonstrate compliance and reduce legal liability.
How can ARs benefit from structured workflows in a shared compliance environment?
Authorised Representatives benefit from structured workflows in demonstrating regulatory compliance with Article 11 of the MDR and the IVDR.
What are the compliance challenges importers face in verifying device documentation before market release?
The Importer role is often a role shared with the Authorised Representative or the Distributor. Both Economic Operators face challenges in obtaining the right documentation at the right time from the Legal Manufacturer. As for the Authorised Representative, these parties may face regulator non-compliance if not demonstrably performing the tasks required by Article 13 or Article 14.
Why do importers need digital tools to manage Article 13 obligations effectively?
Importers require the information from the manufacturers to perform their tasks under Article 13. Especially when representing multiple Legal Manufacturers, it may be complex to receive information in a systematic and structured manner and document the verification tasks in a structured manner. As such digital systems can support to evidence compliance.
What regulatory challenges do distributors face in ensuring documentation completeness?
The Importer role is frequently combined with that of the Authorised Representative or Distributor. Both Economic Operators often encounter difficulties in receiving the necessary documentation from the Legal Manufacturer in a timely manner. Similar to the Authorised Representative, these parties risk regulatory non-compliance if they cannot demonstrate fulfillment of the responsibilities outlined in Article 13 or Article 14.
Why is it difficult for distributors to manage incident reporting and product withdrawals without centralized tools?
Today, medical device feedback processes between Economic Operators are disconnected. Often the Legal Manufacturer has no insight in the post-market feedback received by other Economic Operators. At the same time, there are strict evaluation and reporting timelines in place that require information to be shared.
With added requirements through the IMDR classification coding, tools such as MDIS can help to streamline reporting between Economic Operators and by reporting to the Regulatory Authorities.
How can a digital compliance system improve distributor-level traceability and reporting?
Digital compliance systems, such as MDIS, have the ability to trace products along the full Economic Operator chain, starting with the Legal Manufacturer, all the way downstream to the Distributor, and back up to the Legal Manufacturer.
It ensures the availability of Technical Documentation, Accompanying Documentation, Declaration of Conformity and where applicable the CE certificate for Basic-UDI-DIs and the UDI-DIs.
What features should distributors look for in a post-market compliance support platform?
It is important that systems ensure the traceability of UDI-DI’s for Basic UDI-DI’s from the Legal Manufacturer all the way onto the market. In addition, having integrations with systems of EUDAMED help to streamline compliance processes. Systems should ensure the secure sharing of data, and having the documentation available 24/7.
What makes centralized systems like MDIS more effective for EU-wide compliance collaboration?
The MDIS platform is unique, there are no other systems which facilitate to cross-Economic Operator cooperation. It saves valuable time by sharing the documentation across the Economic Operators, and by facilitating EUDAMED registration.
How can MDIS help reduce the burden of redundant document requests across stakeholders?
As the Legal Manufacturer uploads their documentation, all parties have automatically access to the items that are relevant to them. None of the parties needs to rely on legacy sharing systems which require manual actions, such as sharing drives, folders, or other types of file-sharing systems.
In what ways does MDIS ensure data integrity and audit readiness for all EOs?
All data stored within MDIS is stored in a ISO/IEC 27001 compliant environment. Data integrity is further verified through verification actions by each of the Economic Operators.
Having all information in a single location support audit readiness and makes demonstration of compliance to Regulatory Authorities and Notified Bodies simpler than ever.
