Your Notified Body may ask to see your strategy for regulatory compliance during your next audit. Do you have one?

February 18, 2021

As European regulatory compliance becomes more complicated many medical device and IVD manufacturers have had their Notified Bodies ask them for a written “strategy for regulatory compliance” document. Given a choice, most regulatory professionals would prefer to not experience the same “deer in the headlights” moment these manufacturers must have had when asked for this by their auditor.

The need for a regulatory strategy stems from Article 10(9a) of the EU Medical Device Regulation (MDR) or Article 10(8a) of the In Vitro Diagnostic Medical Devices Regulation (IVDR)  which states:

“The quality management system shall address at least the following aspects: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to devices covered by the system.”

The MDR /IVDR does not explicitly state that your regulatory strategy must be written but that’s the expectation. So, what exactly does “strategy” mean? The intent is to provide a high-level summary of your regulatory compliance efforts for a device/device family in Europe and other major markets. This document needs to be maintained over the lifecycle of the product. You should start early in the design phase and continue modifying it over time.

Don’t panic if you don’t have one…yet

If the very idea of adding this to your current workload might make your head explode, our team can certainly help prepare this regulatory strategy for you, as we have done for other customers. Following is a simple template you can follow to draft your REGULATORY COMPLIANCE STRATEGY or contact us to see how we can help.

 


 

[date]

Regulatory Compliance Summary for: [XYZ Medical Device/IVD Device]

 

REVISION HISTORY:

Purpose

Purpose of Document

Scope of Activities

Exemptions or Non-Applicable Activities

Device and Manufacturer Information

Description of Device

Intended Use, Indications and Purpose

— Intended Use

— Indications for Use

— Intended Purpose

Manufacturer

— Legal Manufacturer

— Regulatory Role

— Person Responsible for Regulatory Compliance

— Manufacturing Information

Reference Documents

Documents table

Marketed Device Identification

Common Name of Device

— GMDN Code and Description

— Basic Unique Device Identifier (B-UDI) Number

Trade Name/Brand Name of Device

Model or Version of Device

Legal and Regulatory Requirements

Process for Identification

Process for Updating

Regulatory Classification and Requirements by Country

Marketed Device Jurisdictions

Current Licenses by Market

European Union Marketing History

Information Supplied to User

Product Claims

Similar Devices on the Market

Design and Development

Design and Development Background

Regulatory Compliance

— Identified Standards

— Regulatory Requirements

— Identified (EU) Common Specifications

— Additional Requirements

Design Changes Summary

Risk Management

Lifetime of the Device

End of Marketing

Product Realization

Medical Device File/Device Master Record

Manufacturing Activities

Monitoring and Measuring

Outsourced Processes

Packaging and Labelling

Shipping and Distribution

Regulatory Notification

Post Market Surveillance

Post Market Surveillance

Customer Feedback

Adverse Event and Vigilance

Periodic Review

 


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