Compliance

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ANNEX IX

  • QMS assessment
  • For devices class Is, Im, Ir, IIa, IIb, III : Manufacturer shall have a QMS assessed by a Notified Body.  For simple Class I and custom made devices, a manufacturer must have a QMS, but this is not checked by a Notified Body.
  • For class Is, Im, Ir at least a yearly surveillance audit by Notified Body limited to sterility, measuring, reusability process
  • For class IIa, IIb, III, at least a yearly surveillance audit by Notified Body
  • Technical documentation assessment
  • For devices IIa,: Manufacturer shall have technical documentation assessed by a Notified Body, including clinical evidence for at least one representative device for each category of devices.
  • For devices IIb, Manufacturer shall have technical documentation assessed by a Notified Body, including clinical evidence for at least one representative device per generic device group
  • For devices III, Manufacturer shall have the technical documentation of each device assessed by a Notified Body, including clinical evidence.
  • Additional procedures :
  • For the following class IIb and class III devices :
  • Implantable and active devices to administer / remove medicinal substances : notified body shall submit a clinical evaluation assessment report to the Commission expert panel for a scientific opinion (~60 days procedure) before issuing certificate.
  • Devices incorporating a medicinal substance : notified body shall consult the medicinal authority EMA/other designated CA (Directive 2001/83/EC) before issuing certificate (~210 days procedure).
  • Devices with viable or non-viable tissues or cells of human or animal origin, or derivatives : notified body shall consult the ‘human tissues or cells authority’ (Directive 2004/23/EC) or the medicinal authority EMA/other designated CA (Directive 2001/83/EC) before issuing certificate.

A Notified body shall prepare a clinical evaluation report and shall submit it to the Commission. The Commission will transmit the report to an expert panel which will decide whether to provide a scientific opinion on the clinical evaluation assessment report. (Annex IX 5.1) (Scrutiny process).

ANNEX X

  • Type-examination conformity assessment for class IIa, IIb, III :  examination based on technical documentation vs prototype sample

ANNEX XI

  • Product conformity verification for class IIa, IIb, III : complementary to the ANNEX X procedure, verification based on the prototype sample vs final product
  • Production quality assurance or
  • Product verification

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