What are custom-made medical devices?

How are custom-made devices regulated compared to mass-produced medical devices?

What criteria define a medical device as "custom-made"?

What role do healthcare professionals play in the regulation of custom-made medical devices?

How do regulatory agencies balance patient safety with the need for innovation in custom-made medical devices?

Are there specific documentation requirements for custom-made medical devices?

What challenges do regulatory agencies face in overseeing custom-made medical devices?

How do international regulations impact the manufacturing and distribution of custom-made medical devices?

In what ways can the regulation of custom-made medical devices evolve to keep pace with technological advancements?

What considerations should manufacturers of custom-made medical devices take into account to ensure regulatory compliance?