Compliance

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 assessment 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

Learn More:

• The Regulation: MDR 2017/745
• Scope
• Classification
• Technical File
• Notified Bodies
• Authorized Representatives
• Custom Made Devices
• Clinical Evaluation & Clinical Investigation
• Systems & Procedure Packs

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