Chapter 4: Components of Regulatory Strategy – The Basics
58 Regulatory Affairs Professionals Society
• Some countries have more expedient approval
processes if the device has an EU CE Mark, an
FDA clearance, or approval and/or marketing
authorization in the country of origin. The team
should consider these factors when devising the
strategy.
• A complete strategy should consider potential
changes during plan execution.
• The team should create a routine process for
both developing and monitoring all regulatory
strategies.
• Any new elements in a device deserve special
attention. Although many potential changes can
occur during device development and marketing,
a new element can offer the most unknowns.
Understandably, regulatory authorities are
cautious when faced with a new technology or
clinical application. Unexpected questions may
arise during the review, as reviewers need to
become comfortable with the new device. Careful
attention to a device’s new element(s) can miti-
gate much of this risk.
• Generating a GRS is a team activity and
should include the project team or other stake-
holders (see Chapter 2 on Development and
Implementation of Regulatory Strategies for
Medical Devices). This approach keeps them
involved and manages their expectations as to
the output. During research, some twists and
turns may arise. Working closely with the project
team allows a focus on what is important for the
ultimate success of the project.
References
1 European Commission. EU UDI helpdesk. Accessed 28
November 2025. https://webgate.ec.europa.eu/udi-helpdesk/
en/other-relevant-information/medical-device-classification.
html
2 Japan Health Policy NOW. Medical devices. Accessed 28
November 2025. https://japanhpn.org/en/section-6-4
3 US National Library of Medicine. MEDLINE/PubMed.
Accessed 27 January 2026. https://pubmed.ncbi.nlm.nih.gov
4 Food and Drug Administration. Search for FDA guidance
documents database. Accessed 27 January 2026. https://www.
fda.gov/regulatory-information/search-fda-guidance-
documents
5 European Commission Public Health. Guidance – MDCG
endorsed documents and other guidance. Accessed 27
January 2026. https://health.ec.europa.eu/medical-devices-
sector/new-regulations/guidance-mdcg-endorsed-
documents-and-other-guidance_en
58 Regulatory Affairs Professionals Society
• Some countries have more expedient approval
processes if the device has an EU CE Mark, an
FDA clearance, or approval and/or marketing
authorization in the country of origin. The team
should consider these factors when devising the
strategy.
• A complete strategy should consider potential
changes during plan execution.
• The team should create a routine process for
both developing and monitoring all regulatory
strategies.
• Any new elements in a device deserve special
attention. Although many potential changes can
occur during device development and marketing,
a new element can offer the most unknowns.
Understandably, regulatory authorities are
cautious when faced with a new technology or
clinical application. Unexpected questions may
arise during the review, as reviewers need to
become comfortable with the new device. Careful
attention to a device’s new element(s) can miti-
gate much of this risk.
• Generating a GRS is a team activity and
should include the project team or other stake-
holders (see Chapter 2 on Development and
Implementation of Regulatory Strategies for
Medical Devices). This approach keeps them
involved and manages their expectations as to
the output. During research, some twists and
turns may arise. Working closely with the project
team allows a focus on what is important for the
ultimate success of the project.
References
1 European Commission. EU UDI helpdesk. Accessed 28
November 2025. https://webgate.ec.europa.eu/udi-helpdesk/
en/other-relevant-information/medical-device-classification.
html
2 Japan Health Policy NOW. Medical devices. Accessed 28
November 2025. https://japanhpn.org/en/section-6-4
3 US National Library of Medicine. MEDLINE/PubMed.
Accessed 27 January 2026. https://pubmed.ncbi.nlm.nih.gov
4 Food and Drug Administration. Search for FDA guidance
documents database. Accessed 27 January 2026. https://www.
fda.gov/regulatory-information/search-fda-guidance-
documents
5 European Commission Public Health. Guidance – MDCG
endorsed documents and other guidance. Accessed 27
January 2026. https://health.ec.europa.eu/medical-devices-
sector/new-regulations/guidance-mdcg-endorsed-
documents-and-other-guidance_en