Design Changes

Design changes for a medical device is very common due to many reasons such as a replacement with a better and cheaper components or to comply with a new regulatory guideline. 

 

For example to comply with Restriction of Hazardous Substances (RoHS) also known as Directive 2002/95/EC and it was originated from European Union to restricts the use of six hazardous materials found in electrical and electronic products. All applicable medical device in the after July 1, 2006 must pass RoHS compliance. 

 

Therefore, medical device companies may have many design changes to comply with RoHS in order to market the product in the EU. This may be a major design change involving many components depending on the complexity of the medical device in question.

 

In general, there are two types of design changes, the first is during design process of the device and the second is changes after the device had been released. 

 

During the design process, for example, before design output documents are transferred to production, design changes are controlled internally within the Design Engineering group and other per company protocol. 

 

In this phase the project manager of the developmental product has the authority to approve all changes. The manner in which the request for change, its review, and change authorization are documented depends on the nature of the change and how early or late in the design cycle the change is done. 

 

Typically, these changes are documented as notes on design documents such as:

• Drawings
• Specifications,
• Calculations,
• Minutes of design review meetings

However, after the design is released to regulators for pre-market approval, is undergoing clinical trials, or is released to production, it will be a lot more involvement of many departments like regulatory affairs, engineering, marketing and validation group etc. 

 

The changed device many need to have to be partially validated again or the engineering group many need to perform risk analysis and update the risk managemet file. 

 

The sponsor should also comply with Engineering Change Request, Control of Documents and regulatory affairs protocol. For example, after the product is deemed RoHS, the label should have a sticker of RoHS added to that effect.

Reference	Criteria
21 CFR 820.30(i)	Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.