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Regulatory Compliance Strategy for Medical Devices – An Overview

calendar30 Mar, 2023
timeReading Time: 4 Minutes
Regulatory Compliance Strategy for Medical Devices - An Overview

A Regulatory Compliance Strategy for Medical Devices is a routinely published official report that modifies the business strategy and regulatory actions to introduce a new or altered medical device to the market. It acknowledges the important regulatory components that must be addressed and gives the task’s overall definition. Medical devices manufacturers can more successfully plan the release of new goods if they take into account the whole range of material regulatory issues at the earliest possible stages of product development. With an effective regulatory strategy, current problems with the medical equipment can be identified and fixed now, avoiding potentially expensive and time-consuming restorative efforts in the future.

What Is Regulatory Strategy In Medical Devices?

A medical device prior to being sold and utilized in clinical practice, a medical device must comply with all applicable regulatory regulations. This is accomplished through a regulatory strategy. To show the device’s safety and effectiveness, pre-clinical and clinical testing are often conducted. The results are then submitted to regulatory authorities for assessment and approval.

Early on in the device development process, a strategy should be created, and it should be regularly updated as new information becomes available. Understanding the always changing regulatory intelligence for medical devices is urgently needed.

How Does A Regulatory Strategy Varies For Different Markets?

There are several variables that might affect the regulatory methods for medical devices in different countries, and these variables vary from one country to another.

  • Device Approval:  Getting a medical device approved is an essential step in getting it on the market. The approval procedure varies per nation and can take longer and be more stringent. Premarket approval (PMA) is a process that the USFDA[1] uses to approve high-risk devices, while other nations may have less stringent requirements.
  • Device Classification:  Based on the possible risk that medical devices could cause if they break down, they are divided into various risk categories. The level of examination needed for each device type can differ depending on the classification system used in different nations.
  • Device Registration:  Some nations demand periodic renewals and device registration for specific categories of devices.
  • Post-Market Surveillance:  A regulatory plan for medical devices must include post-market surveillance. It aids in ensuring the efficiency and safety of products that are already available on the market. The post-market surveillance requirements in various nations can impact the continuous regulatory burden faced by device manufacturers.
  • Device Labeling:  The standards for device labelling and usage instructions vary by country. To sell their products in a specific market, manufacturers must meet these specifications.

All of these variables are significant in deciding the regulatory strategy for medical devices in various nations, therefore it’s critical for manufacturers to understand the particular regulations in each nation where they want to sell their devices.

Regulatory Compliance Strategy as per EU MDR 2017/745

A requirement of the European Medical Device Regulation (EU MDR 2017/745) and the EU IVDR 2017/746 is having a strategy for regulatory compliance. (European In-Vitro Diagnostic Regulation). In reality, the particular criteria for a Quality Management System required to get the CE marking process are reported in Paragraph 9 of Article 10 of the EU MDR 2017/745 and EU IVDR 2017/746. It is one of these needs, along with:

“A strategy for ensuring regulatory compliance, including adherence to conformity assessment guidelines and management practices for modifications to the system’s covered devices.”

Importance of Regulatory Compliance Strategy for Medical Devices

Manufacturers of medical devices who fail to identify regulatory compliance difficulties early on in the process frequently encounter unpleasant shocks. After the product development process is complete, efforts to achieve compliance with regulatory requirements can be a substantially increasingly difficult task and can cause significant delays in subsequent product development efforts.

What Can Make The Best Regulatory Compliance Strategy For Medical Devices?

Following are some important points to make the best regulatory compliance strategy for medical devices:

  • Establishing A Leadership Team

For managing change compliance and creating an execution procedure that remembers events and systems for the next advancement of compliance operations, effective leadership is crucial. In any case, members of this leadership team should come from regulatory affairs, quality assurance, medical and clinical affairs, marketing, manufacturing, biocompatibility, sterilization, research and development, and labelling. Speaking with the Notified Body and fostering collaboration among the specialty units and product portfolio must both be priorities for this leadership team group. 

  • Conducting A Gap Analysis

When conducting a gap analysis, one of the key concerns that manufacturers should consider is if their present goods are compliant. Manufacturers can determine which compliance technique is generally appropriate for them with the use of a gap analysis. Manufacturers should at the very least carry out: 

  • Technical gap analysis
  • Regulatory gap analysis
  • Clinical gap analysis

Each gap analysis is unique since it is customized to the manufacturer, the therapeutic area, and the product or family of products. Every gap analysis has the same goal, though: to find areas of non-compliance and then fix them so that the product not only complies with regulations but also maintains that compliance.

  • Distributing Resources To Support Compliance Activity

The added requirement of working to comply with the new legislation is probably one that the people employed by factories at the moment have little to no experience with. It is in the best interests of manufacturers who lack the essential skills to budget for and hire the right subject matter experts who can bring the business into MDR compliance and train staff to maintain compliance. 

  • Developing A Regulatory Compliance Strategy For Medical Devices

Medical device manufacturers justifiably bear a heavier burden as a result of the growing unpredictability of the global commercial Centre for medical devices, especially when vying for advertising access across different commercial centers. The majority of companies in the medical device business are small and medium-sized entities, therefore the impact on costs and lead times can be significant. To perform statistical surveys or to navigate the regulatory maze, these organizations frequently require internal knowledge. 

An Effective Regulatory Compliance Strategy For Medical Devices Must Contain A Number Of Elements, Including:

  • Calculating the cost and return on investment for potential market locations.
  • Perceived market demands, 
  •  The competitive environment at the time, 
  • Distribution strategies, 
  • Policies for reimbursement 
  • Legal concerns, particularly intellectual property protection.
  • The capacity to extend market acceptances gained in main markets.
  • Financial, professional, and technical resources. 


Regulation changes may result in fines, penalties, and loss of market access in the global marketplace. Regulatory Compliance Strategy for medical devices, however, can occasionally be a wise choice. The competitive environment will undoubtedly change as a result of changes to regulatory oversight. To turn these Regulatory compliance strategy for medical devices regulations into a source of competitive advantage that will enable them to reap financial rewards, global players need a well-developed and well-implemented plan. Medical technology companies may grab opportunities to lead the industry, successfully negotiate new laws, and disrupt innovation by embracing complexity.

Also Read:
A Step By Step Guide For Registration Process For Medical Devices In India

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