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MDCG Guidance for Manufacturers of Class I Medical Devices

Steps to placing Class I medical devices on the market

Step 0: Integrate MDR in the Quality Management System (QMS)

Step 1: Confirm product as a medical device

Step 2: Confirm product as a Class I medical device

Step 3: Procedures before placing on the market

a)   Meet the General Safety and Performance Requirements (GSPR)

b)   Conduct Clinical Evaluation

a)   Prepare technical documentation

b)   Request Notified Body involvement

c)    Prepare Instructions for Use and Labelling

Step 4: Check compliance with general obligations for manufacturers

Step 5: Draw-up the EU Declaration of Conformity

Step 6: Affix the CE Marking

Step 7: Registration of devices and manufacturers in Eudamed

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