Medical Device Post-Market Obligations, a European Perspective: Part 2 – Assessing Product Changes

Last week, in the first part of this series, we outlined the post-market obligations for Manufacturers under the European IVD and medical device directives. In the second part of this series we are going to discuss another post-market topic – change control.

Much as quality and regulatory peoples’ lives would be made easy, if, once a product is CE marked and launched to the market, nothing changed – no supplier changes, equipment changes, raw material changes etc, in reality, that utopia doesn’t exist.  Products need to be tweaked; manufacturing lines get moved and regulations change.

Manufacturers must actively maintain compliance to the Essential Requirements of the medical device directive.  Product changes therefore must be assessed to determine impact to safety and efficacy of the product.  Manufacturers need to have a change control process in place, ensuring that where necessary, appropriate verification and validation testing is performed prior to change implementation.

From a regulatory perspective, we need to assess if the change has an impact on the contents of the CE Technical File or Design Dossier and secondly, we need to determine if the Notified Body needs to be informed and/or approve of the product change.

The following is an overview of what needs to be considered when performing a regulatory impact assessment of a product change;

  • Impacted products and markets
  • Device classification
  • Impact to:
    • Essential Requirements Checklist
    • List of Standards
    • Risk Analysis
    • Product Label and Instructions for Use
    • Biocompatability
    • Shelf Life
    • Product Specification
    • Clinical Evaluation

Many changes will require an update to the product Technical File or Design Dossier, which can be handled by the Manufacturer internally. However, the Notified Body needs to be informed of changes that are deemed to be “substantial”.  According to the NB-MED guidance document1, changes are deemed  “substantial“, and the manufacturer must inform the Notified Body of changes under the following circumstances:

  1. Product design changes: the change would affect conformity with

–      the Essential Requirements and/or

–      the conditions prescribed for the intended use of the device

  1. Changes to the quality system:

–      the change would affect compliance of the devices covered by the quality system with the essential requirements or the approved type / design or

–      the change means additions to the product-range covered by the quality system

Reporting of changes to the quality system to the Notified Body is relevant to conformity assessment under Full Quality Assurance and Production Quality Assurance (MDD Class I sterile/measuring function, Class IIa, Class IIb, Class III; IVDD List A &B).

Reporting of changes to the design to the Notified Body is relevant to MDD Class III devices and IVDD List A and self-test devices assessed by Design examination.

The guidance document1 also provides some examples of “substantial” changes, and the rationale behind the categorisation of such changes. Manufacturers should develop a system for categorising substantial changes relevant to their product type.

Should you have questions, are unsure of the requirements or need support with your change control process, call or email us here at Acorn Regulatory.  We are happy to help.

  1. NB-MED/2.5.2/Rec2 Reporting of design changes and changes of the quality system http://team-nb.org/documents/2011/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf