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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose     Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in …

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose Read More »

FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products

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FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products     On January 30, the FDA issued its final guidance on Surveying, Leveling, and Alignment (SLA) Laser Products for manufacturers of laser products. The final guidance outlines the FDA’s approach on the applicability of the FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) …

FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products Read More »

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