Change management in Medical Devices is essential to ensure European and international compliance. After the product is first placed on the market, changes in the post-market phase must be monitored and managed, respecting the regulatory requirements of each country where the medical device is marketed. Ineffective and non-compliant management can lead to sanctions, and delays, up to and including withdrawal from the market.

Generally speaking, changes may concern various aspects of the product and process. Examples include design changes (structural changes or new functionalities), replacement of materials with potential clinical and biological impacts, changes in the production process and labelling, and changes affecting the quality management system.

Evaluation of Changes: Substantial vs. Insignificant

When a manufacturer changes a medical device, it is essential to assess whether these changes are substantial (‘substantial change’) and whether they require specific procedures, such as re-registration, updating of authorisations or new conformity assessment. The classification as substantial depends on various factors, mainly the impact on the safety and effectiveness of the device and the requirements of each country.

Each country has specific requirements regarding change management. For example, a change that does not require re-registration in the US, under FDA supervision, might need a full review in the EU according to MDR (EU) 2017/745. Even in the context of the MDSAP (Medical Device Single Audit Program), device changes must be managed according to the regulatory requirements of each of the five participating countries (Australia, Brazil, Canada, Japan and the United States).

A look at the changes in Medical Devices in the EU and MDSAP countries

European Union

According to MDR (EU) 2017/745 and IVDR (EU) 2017/746, a modification to a device is considered significant if it affects the design or intended use, requiring a new conformity assessment and, potentially, a new certification.
In the case of significant changes, the Notified Body must be involved to confirm whether the certification remains valid or whether further steps are required.

Significant changes, according to NBOG BPG 2014-03 guideline, include:

• Intended use: changes involving an extension or variation of the original intended use of the device, such as an extension of the target population.
• Software: changes to the operating system or significant software components, such as the architecture or algorithm.
• Materials or substances: changes to the type of material or formulation that affect chemical or physical properties, such as the stability of the device.
• Sterile conditions: changes in sterilisation methods that alter the guarantee of sterility, including changes in packaging design.

United States
In the United States, significant changes affecting the safety, efficacy and intended use of the device require a new conformity assessment. In such cases, the manufacturer is obliged to submit a new 510(k) or an amendment to the existing registration. Significant modifications include changes to the design, materials, performance or labelling of the device.

Australia
In Australia, variations to Medical Devices are subject to the provisions of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations). If such changes are significant and affect safety or efficacy, a notification to the TGA is required. Under certain circumstances, re-approval will be required. Changes to the design, materials or labelling, which could compromise the compliance of the device, must be carefully examined according to the guidelines provided by TGA.

Japan
In Japan, device modifications must comply with the regulations of the Pharmaceutical and Medical Devices Agency (PMDA) and the Pharmaceutical and Medical Device Act (PMD Act). If considered significant, a new approval or notification to the Marketing Authorisation Holder (MAH) or Accredited Organisation (AO) is required.

Brazil
In Brazil, the regulatory authority ANVISA requires notification or authorisation of significant changes that may alter the safety, efficacy or risk classification, according to RDC 751/2022. These changes must be reviewed by ANVISA, which may request additional documentation.

Canada
In Canada, modifications to Medical Devices are regulated by the Medical Devices Regulations (SOR/98-282). Significant changes require a new application or amendment to Health Canada, while minor ones must be documented and sometimes reported. For changes subject to formal review, the manufacturer must indicate the impact on the device.

NTF (Note to File) Documentation for Changes

Thema, thanks to its vast experience in strategic-regulatory consulting, provides its NOTE TO FILE Form that supports manufacturers in evaluating product and organisational changes and, employing checklists, provides guidance on actions to be taken and procedures to be applied in compliance with the requirements of the European Union and MDSAP countries (USA, Australia, Japan, Brazil and Canada).

Among the many templates offered by Thema, the NOTE TO FILE form is specifically designed to help understand and document whether changes made to Medical Devices are substantial or minor, and to assess their impact on the registration, ensuring proper management of product and process changes.

Adopting an effective change management strategy, supported by accurate documentation, helps companies maintain compliance, deal with audits and communicate with regulatory authorities with confidence, to remain successful in the competitive global medical device market.