NIST GCR 01-815
A Guide to the EU Medical Device Directive

IX. EC Verification by Notified Body (See NIST SP 951 Guide to EU Standards and Conformity Assessment, Page 20).

If the product is a Class I (sterile/measurement function), IIa, IIb, and/or III, the manufacturer will need to prepare for a Notified Body audit in accordance with the following Annexes:

• Annex II EC Declaration of Conformity: Full Quality Assurance System.
  
  
• Annex III EC Type Examination.
  
  
• Annex IV EC Verification (Batch Testing).

  Certain statistical verification procedures can be applied in those cases where it can be determined that batches are homogeneous. A batch is considered to be homogeneous when equivalent parts or materials are manufactured and/or tested in the same manner, without interruption, typically on the same day or in the same time period, and produced by the same person, or with the same machine/equipment set-up and fulfills the same specifications.

• Annex V EC Declaration of Conformity:Production Quality Assurance.
  
  
• Annex VI EC Declaration of Conformity:Product Quality Assurance.

X. Authorized Representation and Competent Authority Registration

The Medical Device Directive requires the appointment of an Authorized Representative for Europe in the event the manufacturer is not established within the European Economic Area (EEA). (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 23.)

The Directive requires that the manufacturer be listed on the label and/or packaging, and in the Instructions and Declaration of Conformity

A non-European resident manufacturer may select an agent, distributor, or a non-commercially involved representative to take up the responsibilities of an Authorized Representative.

The name of the manufacturer and the device must be notified to the Competent Authority in which the manufacturer has his or her registered place of business, the address of his registered place of business, and the description of the devices concerned.

In addition, the manufacturer keeps the Technical File available for review by Competent Authorities (the Department (Ministry) of Health of a Member State), and plays an essential role in vigilance procedures.

XI. CE Marking

CE marking (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 17.)

The manufacturer is obliged to place the CE Marking on the medical device. Annex XII of the Directive instructs the manufacturer on the placing of the CE Marking.

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