Advice
Regulatory information
Regulatory information
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DERM (version number 3.0) obtained UK Conformity Assessment (UKCA) certification as a Class IIa device (March 2022) under UK Medical Device Regulations (MDR) 2002.
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Moleanalyzer pro (version number 3.4) is CE marked as Class I (Annex VIII MDR) under the Annex IX (EU), 2017/745 regulation.
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nomela (version number 4.0) is CE marked Class I under Medical Device Directive, 93/43/EEC, with plans to transition to MDR by 2024.
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SkinVision (version number 6.0) is CE marked Class I under Medical Device Directive, 93/42/EEC, with plans to transition to MDR by 2024.
The Medicines and Healthcare products Regulatory Agency (MHRA) has not reported any safety issues. However, it mentioned that CE markings for SkinVision, nomela and Moleanalyzer pro may not be sufficient for these technologies, and they should be reclassed as Class IIa diagnostic medical devices since a missed diagnosis poses a moderate risk to the person.