IVDR – Overcoming challenges while establishing Regulatory strategy

May 4, 2023

By Julia Selmani
Regulatory Affairs specialist, Key2Compliance AB

Establishing a strategy for regulatory compliance for your company is a new IVDR requirement, defined in Article 10(8a) where the aspects to be addressed by manufacturer’s QMS are listed. Thought ISO 13485 does not explicitly include requirement for Regulatory strategy, it includes the requirement to incorporate regulatory requirements in the QMS as well.

For all IVD manufacturers, and manufacturers of General IVDs (IVDD) in particular, the ongoing transition to IVDR is challenging in regard of upcoming requirement on Regulatory strategy. Due to implementation of IVDR risk-based classification the involvement of Notified Body for conformity assessment of IVD Medical Devices is mandatory for 80% of IVD manufacturers thus the revision of current regulatory strategies for at least CE-marking is inevitable.

According to new IVDR requirement the Regulatory strategy should be a part of QMS processes which means that manufacturer’s Regulatory strategy must be outlined and established as a controlled QMS document, it should be put into effect and kept up to date.

Article 10 does not provide any further details on the content of Regulatory Strategy, but the additional clarification can be found in Annex IX where it is indicated what processes should be included the strategy for regulatory compliance:

  • identifying the legal requirements that are applicable
  • qualifying devices against the applicable regulatory requirements
  • handling equivalence to existing devices
  • choosing the conformity assessment procedures to be used and complying with them

Additionally, the strategy for regulatory compliance could be an appropriate document to define how to address:

  • implementing of requirements for your PRRC
  • applying harmonised standards and common specifications
  • managing relationships with other economic operators in the supply chain, including AR, Importer, etc
  • communicating with your Competent authority and NB

The global version of Regulatory strategy principles, sometimes called International Regulatory strategy, which focuses on the entire world, is an important aspect as well. Considering the International Regulatory strategy in the early phase of your development projects can help you to avoid a common mistake of not including country specific regulatory requirements in planned verification and validation activities resulting extra costs and delay obtaining marketing authorizations.

What to consider when you plan your Regulatory Strategy?

Regulatory Strategy itself can be defined as a plan of action to reach a certain goal/objective, whether it is a CE mark in EU, 510(k) Clearance in US, MDL Import Licence in Canada or TGA Approval in Australia.
Note that obtaining marketing authorization is only a pathway approach and not a strategy!

Planning and establishing your Regulatory strategy early in the process is crucial for business reasons since the involvement of NB bodies and potential registration costs must be justified and anchored with the business case. Regulatory strategy presented for your senior management in a well-structured way will facilitate strategic decisions and allocation of resources required for implementation of your regulatory strategy.
It is always beneficial to involve appropriate functions in your organization early to highlight the importance of regulatory aspects in achieving company’s strategic goals.

Regulatory strategy is a dynamic document, constantly overseen and revised if any changes in regulatory environment impact your current Regulatory strategy.  This should be reflected in your QMS processes and procedures and ensured by strong interconnection between QMS processes.

It is common to consider the work “done” when a product has been CE-marked or launched in a particular market. However, there is a need for regulatory maintenance in majority of markets.

Since all products have a regulatory lifecycle, that must be reflected in your Regulatory strategy for target markets. Establishing long term Regulatory Strategy will facilitate the registration process and reduce risks from both compliance and business standpoint.

When and how to start with Regulatory strategy?

It is never too soon to start!

  • Ensure you have access to relevant and sufficient regulatory competence within your project
  • Ensure that all relevant functions within your organization are involved
  • Implement Risk based approach when planning your Regulatory strategy
  • Determine your device classification which is crucial for the correct estimation of your costs (NB fees, fees for country specific registrations, etc.) and the scope of the project
  • Plan for your Regulatory strategy considering product life cycle perspective
  • Incorporate Regulatory strategy your QMS

When implementing your Regulatory strategy and making it a part of your QMS processes estimate any gaps and put efforts to identify needs for revision or creating new procedures, ensure interconnections between QMS processes, check if they cover at least following:

  • communication and reporting of changes to NB, AR, competent authorities, CH-REP, UKRP, including timelines for license renewals/amendments
  • collecting, evaluation and monitoring of regulatory requirements to ensure continued compliance
  • regulatory strategy periodic overseen/update

Key elements to consider while establishing your Regulatory strategy:

  • Do you have a QMS process for identifying applicable regulatory requirements for your device?
  • Do you have a process for qualifying/classifying your device against the applicable regulatory requirements?
  • Handling equivalence to existing devices?
  • Choosing the conformity assessment procedures to be used and complying with them?

How you address:

  • Implementing requirements for PRRC?
  • Applying harmonized standards, common specifications, national standards?
  • Managing relationships between other economic operators in the supplier chain, including the Authorized Representative and Importer?
  • Communication with your Competent Authority and Notified Body?
  • Communication with Regulatory Authorities in other countries/target markets (ensure the appropriate interpretation of country specific requirements, format/scope of registration submission…)

To summarise:

Establishing, implementation and maintaining of Regulatory strategy for IVD companies demand more awareness of the difference in the approach which must be applied.
We at Key2Compliance are a diverse team of medical device specialists that can assist you in customizing Regulatory strategies by identifying the key responsibilities and subjects against the requirements of IVD MD Regulation (EU) 2017/746 and standards applied for your IVD.
We have knowledge and experience in incorporating Regulatory strategy QMS to gain compliance with the Regulation and ISO 13485:2016.