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Navigating the European Union's Medical Device Regulation: Challenges and crucial aspects for manufacturers

This article is Part 2 of our series about challenges and strategies for manufacturers to master the transition to MDR.

The European Union's Medical Device Regulation (MDR) represents a significant regulatory framework aimed at ensuring the safety and effectiveness of medical devices within the EU market. This article delves into key aspects of MDR, addressing crucial questions for manufacturers, including startups, looking to comply with the regulations. Also, this article explores the bottleneck effects created by the introduction of MDR and provides insights into how manufacturers can cope with these challenges.

Key aspects of MDR and how to address them

Aim of EU Commission with MDR

The primary objective of the EU Commission with MDR is to enhance the safety and performance of medical devices while ensuring a transparent and harmonized regulatory framework across member states. The MDR aims to improve the assessment of medical devices throughout their lifecycle, from design and manufacturing to post-market surveillance.

CE Process Duration

The CE marking process, essential for placing medical devices on the EU market, varies based on the device's classification. Generally, it involves conformity assessment procedures, and the timeline can range from a few months to several years. Stringent testing and documentation are crucial elements influencing the duration.

For all other than risk class I, conformity assessment for MDR requirements is done by the Notified Bodies (NBs) - organisations that audit and evaluate the product safety for medical devices (and other regulated product categories). Those organisation play a key role in the market access for medical devices.

Both, requirements of MDR for notified bodies, and the increased number of devices having to be evaluated by notified bodies due to increased classification requirements and the transition period from MDD to MDR, lead to much higher demand on NB resources. As an effect, the duration for the certification process is mostly longer than 12 months - even 18 months are not unusual, not included the time waiting for acceptance of an application request.

Crucial aspects for manufacturers

Incomplete documentation at the time of application at the Notified Body (NB) will lead to refusal of the application which means waiting time will start again, adding to the duration for certification.
Careful preparation of an application is therefore crucial to reduce time for certification, as well as planning business continuation for the period in which development is finished and market access is not yet possible. 

Need for Clinical Data

The requirement for clinical data depend on the risk class of the medical device. Higher-risk devices typically necessitate clinical evidence to demonstrate their safety and performance. The MDR emphasizes the importance of clinical data, promoting evidence-based assessments for all devices. Also for products already in the market, clinical data need to be gathered, documented and evaluated. In case there was no feedback from the market created in the past, potentially clinical studies will have to be run to get the information needed to create evidence for the appropriate performance and safety regarding the intended use of the device.

Crucial aspects for manufacturers

Since evaluation of clinical data needs to be reflected in the risk management, it is necessary to update any risk management file, also for products that had MDD certifications. If clinical data are available, they need to be thoroughly evaluated. In case of missing clinical data, research and even clinical studies need to be performed.

Creating a Post-Market Surveillance (PMS) System

Establishing an effective PMS system is vital for compliance with MDR. Manufacturers need to monitor the device's performance post-market, collect data on adverse events, and continuously update risk assessments. A well-structured PMS system ensures ongoing product safety and compliance. 

Crucial aspects for manufacturers

Gathering and evaluating data from PostMarket Surveillance requires data-based evaluation criteria for product performance evaluation that are linked with risk and safety considerations.
That means, the PMS plan must be based on the risk management, and demonstrate how the data to be monitored relate to the risk evaluation. Also, in the QMS, the PMS process needs to be layed down accordingly to the more stringent procedure. Tools and procedures need to be introduced for PMS.

Obtaining a Notified Body (NB)

Manufacturers must engage with a Notified Body for conformity assessment. Selecting a suitable NB involves considering their expertise, reputation, and the device's classification. It's essential to establish a collaborative relationship with the NB throughout the certification process.
The challenge is, that several NBs do not offer certifications according to the MDR. The demand for NB resources to get trained on MDR requirements lead to performance decrease in all NB's who qualified for MDR certifications.
This leads to the situation that companies who did not have a contract with a NB for MDD, are having a very hard time finding a NB for MDR now, due to the resource bottleneck of the NBs.

Crucial aspects for manufacturers

Taking into consideration the time for certification, another 6 months should be foreseen to obtain a NB for new medical device manufacturers.
A workaround for startups might be to align with legal-manufacturers-as-a-service companies or have a close relation to well-established consulting companies.

Deliverables to the Notified Body

To obtain CE marking, manufacturers must submit a Technical File or Design Dossier to the Notified Body. This comprehensive documentation includes details on the device's design, performance, risk assessment, and compliance with MDR requirements. Thorough preparation and adherence to regulatory guidelines are crucial.

Crucial aspects for manufacturers

Since incomplete / obviously incoherent documentation can lead to refusal of an application by the NB, and to make sure all risk management related activities are well traced throughout the device design and documentation, a digital system that supports the creation of the technical documentation is recommended. Of course this digital system will have to be well integrated with the quality management system.

Opportunities for Startups

Startups face unique challenges, but they can certainly navigate the MDR landscape successfully. With strategic planning, early engagement with regulatory experts, and a focus on quality and safety, startups can bring innovative medical devices to the EU market. 

Crucial aspects for manufacturers

Startups have the best situation to set up a QMS and Technical Documentation (TD) system from scratch to make sure that they are aligned with the requirements of MDR, and easily allow reflection it's individual specialty of innovative product design. Collaborating with experienced partners, including Notified Bodies and external legal manufacturers can also facilitate the process.

Strategies to overcome the bottleneck effects of MDR on Notified Bodies and other resources

Decide whether to re-certify existing products vs. new product application

The re-certification of existing products poses a significant challenge for manufacturers, requiring extensive documentation updates, potential design modifications, and adherence to stricter regulatory standards.

Coping Strategies:

  • Prioritize a systematic review of existing products against MDR requirements.

  • Plan and allocate resources for necessary modifications and updates to technical documentation.

  • Engage with Notified Bodies (NBs) early in the process to streamline re-certification procedures.

Utilize existing relations with NBs vs. Finding NBs

Some manufacturers may face challenges if their current NBs lack the capacity or expertise to handle the increased workload associated with MDR compliance. New companies will have to identify a NB that has capacities for new manufacturers.

Coping Strategies:

  • Initiate early communication with existing NBs to assess their readiness for MDR.

  • Diversify relationships by exploring partnerships with multiple NBs to ensure flexibility.

  • Consider collaborating with NBs specializing in specific product classes to enhance expertise.

  • Consider going under the umbrella of a legal-manufacturer-as-a-service who has well established NB relations 

New Products vs. Legacy Products

Balancing the introduction of new products with the continued support of legacy products by the notified bodies can strain resources and slows down regulatory processes for manufacturers.

Coping Strategies:

  • Develop a prioritisation strategy based on the commercial significance and market demand for each product.

  • Consider leveraging regulatory consultants to streamline submissions for both new and legacy products.

  • Implement a phased approach to compliance, focusing initially on high-priority products.

  • start fully digitalizing your legacy device documentation in order to easier make those products compliant with MDR (very likely this does not only refer to the documentation)

Pass by "dinosaurs" blocking Notified Bodies

Concerns have been raised that MDR, with its increased regulatory requirements, may hinder innovation by creating barriers for smaller companies and startups.

Coping Strategies:

  • For regulatory authorities:

    • Foster collaboration between regulatory bodies, industry stakeholders, and startups to address regulatory challenges.

    • Encourage regulatory agencies to provide guidance and support tailored to the unique needs of startups.

    • Advocate for regulatory pathways that balance safety with the need for innovation, fostering a dynamic and competitive market.

  • if you are a startup - do not give up and be innovative and creative also regarding your pathway to certification

  • implement all of the above strategies and decide early on the first target markets for new products and how to continue marketing of legacy devices

  • for legacy device manufacturers: consider looking at innovative startups that might develop valuable replacements for legacy devices

The introduction of MDR in the EU has undoubtedly brought about challenges, but with strategic planning, proactive engagement with regulatory bodies, and a commitment to compliance, medical device manufacturers can successfully navigate these bottlenecks. By embracing the changes and leveraging the support of NBs and regulatory experts, companies can not only meet regulatory requirements but also contribute to a safer and more innovative healthcare landscape in the European Union.

Navigating the MDR landscape requires a thorough understanding of regulatory requirements, a commitment to quality, and collaboration with experienced partners. Whether you are a startup or an established manufacturer, compliance with MDR is essential for accessing the lucrative European medical device market while prioritizing patient safety and well-being. Having the right tools in place for QMS and documentation is a crucial success factor for the time to product marketing and thus for the business success of your company.

About the Author
Regina Preysing
Partnerships Manager