This is the first part of an article series about MDR transition, what it means for manufacturers and how transition can be sussessful.

The European Union's Medical Device Regulation (MDR) marks a significant departure from its predecessor, the Medical Device Directive (MDD), ushering in a new era of regulatory standards for medical devices.

This article explores the transformative changes introduced by MDR, emphasising its key areas of improvement over MDD. From heightened safety and performance requirements to extended scope and classification, enhanced post-market surveillance, and stricter clinical evidence mandates, MDR aims to bolster the regulatory framework and ensure a higher level of protection for public health and safety for the patients and users of medical devices.

However, higher level of requirements for medical devices have to be fulfilled by manufacturers and other stakeholders of the medical device market - which leads to increased efforts for all of them. In our series of artocle, we will try to give you an overview about the changes and their challenges, and how to respond effectively to cope with the challenges.

Increased Stringency in Safety and Performance Requirements

Key difference

MDR introduces a substantial increase in stringency by implementing 23 General Safety and Performance Requirements (GSPRs), a notable leap from MDD's 13 Essential Requirements (ERs). This heightened emphasis on safety and efficacy extends throughout the entire lifecycle of medical devices, promising a more robust regulatory approach. 

Effects for manufacturers

Manufacturers will need to adapt to a more stringent and complex set of requirements. A broader range of safety and performance aspects must be addressed in the design, manufacturing, and post-market phases of medical device development. More effort is needed by the manufacturers to prove compliance with all 23 GSPRs.

Strategy for compliance

The increased stringency in safety and performance requirements emphasise the need for automation of traceability and information re-use for the product documentation to keep documentation manageable while aligning it to an increased number of the GSPRs.

Extended Scope and Classification:

Key difference

MDR expands the scope of regulatory oversight, encompassing a broader range of products, including certain software, aesthetic devices, and those designed for cleaning and disinfection. The regulation provides more specific and detailed rules for classifying devices, ensuring clarity and consistency in determining their risk categories.

Effects for manufacturers

Manufacturers need to thoroughly understand and interpret these definitions to ensure accurate classification and compliance. The MDR introduces more specific and detailed rules for classifying devices, which can add complexity to the classification process, and require a thourough understanding of the regulatory requirements. Manufacturers may need to reevaluate the classification of their existing products in accordance with the new rules. This process can be resource-intensive, requiring a reassessment of the risk associated with each device and potential adjustments to meet the updated classification criteria.

With the more detailed classification rules, manufacturers may face increased documentation requirements to support their classification decisions, and potentially a new regulatory strategy. For those manufacturers who need to re-classify their product, that mostly means more efforts and resources are needed for additional risk management activities including adoption of product design, testing, and documentation. Since re-classification of products must be supported by quality measures, also processes must be adopted and documentation accordingly. Especially manufacturers of software as medical device will have to face these challenges.

For both manufacturers and notified bodies the extended scope and classification of product requires more resources and time to interpret, align, and validate products, processed and documentation accordingly.

Strategy for compliance

Start early with classification of the device - already with the idea of the product, and create the regulatory approach at the beginning of product development. Whit existing devices and potential re-classification, start prioritizing evaluation based on business and patient need for the products.

Enhanced Post-Market Surveillance (PMS) Requirements:

Key difference

MDR places a stronger emphasis on post-market surveillance, holding manufacturers accountable for actively monitoring and reporting on the performance and safety of their devices post-market. This includes more detailed reporting requirements, quicker reporting timelines for specific incidents, and improved traceability.

Effects for manufacturers

This requires manufacturers to implement internal processes and tools for incident gathering and reporting of their devices, as well as adding monitoring measures to the design of their products or product components and user information. Expertise on clinical evaluation criteria and resources for market surveillance methods is needed for all products which poses risks for resource accessibility to manufacturers.

Strategy for compliance

Larger, mature manufacturers should prioritize their products regarding availability of clinical and monitoring data and market importance. Generally, a PMS strategy can only be derived from traceability of product features to risks and clinical effects. To achieve this, digitalized technical documentation ("eTD") should be set up to ensure traceability for the future. Also, in an eQMS with digitalized processes PMS activities that include various users and departments will me much easier to follow and demonstrate to auditors.

Stricter Clinical Evidence Requirements

Key difference:

MDR mandates more robust and comprehensive clinical evidence, requiring manufacturers to conduct clinical evaluations based on clinical data and scientific literature. The focus is on demonstrating the safety and performance of the device throughout its entire lifecycle, elevating the standards for evidence-based assessments.

Effects for manufacturers

This puts a higher burden on resources that create clinical evaluation, and especially on those creating clinical data - may that be from clinical studies, or from literature research. Especially for legacy device manufacturers this may create unexpected higher market access hurdles due to a lacking of clinical use monitoring and data gathering in the past. Conducting clinical trials, collecting data, and performing comprehensive evaluations demand substantial financial investments and can extend product development timelines. Smaller companies are disproportionately affected by the resource demand for stricter clinical evidence requirements.

Strategy for compliance

Think about the needed clinical data when setting up the intended use in the beginning of product development and evaluate their accessibility before starting the development of a new product. Early include clinical experts. Raise funds, or collaborate with later users / payer organisations. Start early to include clinical state of the art information. Create digitalized technical documentation ("eTD") to allow easier communication with clinical experts, and support product changes before and after market access according to clinical evaluation outcomes.

Increased Transparency and Traceability

Key difference

MDR introduces measures to enhance transparency and traceability through initiatives like the European Database on Medical Devices (EUDAMED) and the implementation of unique device identifiers (UDIs). These measures contribute to clearer identification and traceability of devices, fostering a more transparent regulatory environment.

Effects for manufacturers

Manufacturers have to set up processes for UDI definition and adopt the labelling of their products. Although "full functionality" of EUDAMED has recently been postponed to 2029, medical device and IVD manufacturers are required to register their products in EUDAMED. Again, manufacturers most likely have to dedicate time and resources for investigating, planning and implementing the re-labelling of their products and communication efforts with UDI and EUDAMED related institutions.

Strategy for compliance

Plan resources for product identification as dedicated activity. Include an existing product portfolio in ID creation. Use the support of external experts to help save internal resources. Use digitalised technical documentation ("eTD") to ease the process of re-labelling and support labelling validation.

Strengthened Notified Body Oversight

Key difference

MDR imposes stricter requirements on Notified Bodies (NBs), the organizations responsible for assessing conformity to regulations. Increased competency and transparency requirements contribute to a more consistent and rigorous assessment process, ensuring a higher standard of regulatory scrutiny. However this has lead to a shortage of NB capacities since 2022 which increases the need for early and complete applications for medical device market access in the EU.

Effects for manufacturers

Getting a Notified Body to evaluate the conformity with MDR can be hard to impossible for new manufacturers. Existing manufacturers will have to face longer waiting time for acceptance and validation of an application - up to 18 months!

Strategy for compliance

Start involving NBs as early as possible when starting a new product development. Collaborate with existing manufacturers or external development service providers with existing relation to notified bodies. Provide complete documentation for application - validate your documentation by a pre-audit. Create your application documentation from digital documentation systems that allow easy change, ensure information reuse, and have inbuilt review and approval capabilities on any level of content ("eTD").

Improved Vigilance and Market Surveillance

Key difference

MDR strengthens vigilance and market surveillance activities, facilitating quicker identification and response to safety issues. Extensive reporting obligations for manufacturers, distributors, and competent authorities enhance the ability to address potential risks promptly.

Effects for manufacturers

Manufacturers will have to put more resources in the design of effective vigilance and market surveillance processes. Also, traceability from market incidents to risk management, process and product changes is a must for manufacturers - covering various tools and processes throughout authority and manufacturer's infrastructures. To setup robust and easy-to-use integrations of these, standardisation of product information and digitalisation of product documentation is essential. Again a task that requires additional resources, tools adoptions, and that includes waiting time for inclusion of stakeholders to derive relevant standard formats and information exchange procedures and protocols.

Strategy for compliance

Use fully digitalised tools for process and product documentation to support overview of actions and changes from market feedback. Also, digitalised systems like eQMS or ticket applications will support standardising market feedback content and decision criteria how issues shall be managed to make sure the feedback response serves the safety of products.

Clearer Roles and Responsibilities

Key difference

MDR clarifies and strengthens the roles and responsibilities of stakeholders in the medical device supply chain. This includes manufacturers, importers, distributors, and authorized representatives, establishing a more transparent and accountable regulatory framework.

Effects for manufacturers

All stakeholders including manufacturers are facing challenges from this change - transitioning within an existing process and resource ecosystem, increased oversight and scrutiny from regulatory authorities, consistency of roles within complex supply chains and others increase the need for skilled resources and more infrastructure which most likely may result in higher costs of products.

Strategy for compliance

Implement digitalised quality management and documentation systems and digitalise quality processes like supplier management to support setting up and traceability of roles and responsibilities throughout the process landscape. Set up more frequent internal auditing and monitoring of the processes that involve other stakeholders - also this will be easier with a digitalised quality management system ("eQMS").

Harmonization and Alignment with International Standards.

Key difference

MDR aligns closely with international standards, promoting harmonization in the regulation of medical devices. This alignment enhances global competitiveness for manufacturers and facilitates international trade, fostering a more interconnected and standardized approach to regulation.

Effects for manufacturers

That might ease international market access for manufacturers based on the same design decisions and product and process documentation. As standards and expectations for clinical evidence evolve, manufacturers must stay informed and adapt their practices accordingly. Continuous monitoring of regulatory updates and guidance is essential to ensure ongoing compliance and successful product submissions.

Strategy for compliance

Use external expertise to catch up with evolvement of regulations and evaluate their effectiveness on products and processes. Allow easier implementation of regulation changes by using digitalised systems for quality management ("eQMS") and product documentation  ("eTD") that reuse information and support changes of procedures and documentation on any level and easy evaluation of change effectiveness.

In summary, the European Union's Medical Device Regulation represents a comprehensive and forward-looking regulatory framework, addressing the limitations of its predecessor, the Medical Device Directive. Through heightened safety requirements, an expanded scope, strengthened post-market surveillance, and overall improvements in transparency and accountability, MDR aims to ensure a higher level of protection for public health and safety in the rapidly evolving landscape of medical device technology. On the other side, challenges for all stakeholders in medical device manufacturing, marketing and operation have increased which might potentially result in significant changes in the European medical device market landscape.

For manufacturers of medical devices, most of these new requirements raise the hurdles for entering the EU market, even with existing devices. More resources, more expertise, more time are required for setting up appropriate processes and documentation. You could say, that for new manufacturers it is more easy to create the landscape for quality and product processes and lifecycle regulatory requirements than for existing manufacturers since they have to change and adopt what they had been investing into in the past. Especially to meet the higher requirements for risk management in design and processes, and to create evidence based on data, product documentation will have to be much more detailed than before, and allow traceability throughout the product lifecycle including the development phase.

MatrixRequirements is a platform that is here to support the detailed documentation and traceability due to the item based approach that allows linking to risk management activities throughout the product lifecycle phases for every feature, function, component and part, and automated creation of documentation re-using the information items and data. This way, setting up of complex product documentation according to the respective classification of a medical device will be possible while focussing on the processes and product development and risk evaluation rather than on document management.

Check out our next parts of this series with more details on how manufacturers can cope with MDR requirements.