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Clinical investigations of medical devices - not for CE marking

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Michael Ayers

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Article 62 of the regulations list the applicable articles to follow for clinical investigations for CE marking purposes
Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes
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For clinical investigation of non CE marked devices and not for the purposes of CE marking (e.g. pure research), are the requirements under the regulations covered by this part of Article 82?
Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1), shall comply with the provisions of Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4) and Article 62(6).
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Are there any other requirements in the regulations for these devices and these studies?
 
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