Q&A: Navigating A Regulatory Minefield For Medical Devices

Medical device manufacturing is subject to a complex network of regulations from a handful of different governing bodies such as the FDA and OSHA. If you’re planning to market and sell a new product, you have to coordinate with the equivalent bodies in every country.

Medical device manufacturing is subject to a complex network of regulations from a handful of different governing bodies such as the FDA and OSHA. If you’re planning to market and sell a new product, you have to coordinate with the equivalent bodies in every country. Manufacturing.net spoke with Todd Konieczny of Intertek, a provider of testing, inspection and certification services for manufacturers in a variety of industries, including medical devices, to discuss how companies can better navigate the always-complex international network of regulations and certifications. Todd Konieczny is a technical manager for Intertek’s medical division and also serves as assistant chief engineer for the Americas Region.

Manufacturing.net: What are the most significant medical device regulations that manufacturers need to stay aware of?

Todd Konieczny: Medical device regulations are best broken up by region. In North America, U.S. medical device manufacturers must follow FDA regulations and Canadian manufacturers must comply with the regulations of Health Canada. Once these regulations have been met, manufacturers can achieve full market access through the certification of their products by an OSHA-approved Nationally Recognized Testing Laboratory (NRTL), proving that their products have been tested to current electrical safety standards.

In Europe, medical devices require a CE mark. While this mark is self-declared, manufacturers must go through a notified body for a control number demonstrating that the product has been tested properly and meets all designated requirements. In addition, each country has their own unique regulations at the city, state and national levels that medical device manufacturers must be aware of and comply with.

The 37 countries that comprise the medical portion of the CB Scheme all test for the International Electrotechnical Commission (IEC) standards. The CB Scheme offers manufacturers a simplified way of obtaining multiple national safety certifications for their products. Since these members all test to the same basic rules, a product sold in the U.S. would not need to be tested in Australia or Japan, as long as the applicable national deviations have been evaluated. Instead, the manufacturer would be required to provide a report with testing data to any of the 37 countries in which they would like their product sold for their review and approval.

M.net: Is the regulatory picture different on an international level or do countries share many standards?

Konieczny: Due to the CB Scheme, we are as close to global harmonization with the standards as we have ever been. When the second edition of the IEC 60601 standard was in place, manufacturers had to meet nearly 30 pages of deviations for the U.S. With the third edition, the U.S. now has only five or six pages of deviations, Canada has eight and Switzerland has two or three. All other countries use the IEC version of the standards, which is a universal internationally-accepted version of the standard.

Under the umbrella of the general IEC 60601 standard that all medical devices must meet, up to 80 part two standards have been developed that must be met in addition to the base standard. Some devices such as CT systems or MRI systems fall into these specific categories and may require certain modifications. There are also collateral standards that are very broad and cover everything from x-ray equipment to home healthcare devices.

M.net: What kinds of regulations seem to confuse manufacturers most frequently?

Konieczny: Some of the most common reasons medical devices fail the certification process relate to electro-magnetic compatibility (EMC) - what the product is emitting in addition to what it is susceptible to.

Another area that causes some of the biggest issues is the manuals and markings. Oftentimes manufacturers bring a device into the certification process without having read through the standard and realize certain statements, warnings or descriptions are missing. Whether it is the symbols used on the packaging or incomplete operator manuals, we probably see about a 98 percent fail rate in this area.

The risk management process review has also been one of the greatest challenges. Originally, we had to review the manufacturer’s actual risk management process against the requirements of ISO 14971. The first amendment to the third edition will remove this requirement and state that ISO 14971 only be applied to the product’s risk management file and not the actual process.

M.net: How complex is the regulatory picture if a company tries to do it on their own either through internal staffing or hiring consultants?

Konieczny: It depends on the size and expertise of the company. I’ve seen small companies get their products listed and receive the necessary reports within two weeks. I’ve also worked with major corporations that debate about each item they do not comply with instead of making the necessary changes, which prolongs the process.

Companies that do not initially partner with someone who is familiar with the standards and can help with the re-design typically have many rounds of re-testing. We always recommend conducting a design review as a form of early intervention. During this process, an engineer from the manufacturer informs us of their plans for the product so we are able to tell them what standards to focus on and in what areas other similar products have failed.

In order for the review to be effective the first time, a client must come in prepared. Without questions or a basic understanding of the standards, the process will not be as helpful for the client. It is also important that we know what countries they want to test for as countries such as Japan have their own specific requirements. If we know upfront which country’s requirements we will ultimately by testing to, we can save our clients time and money.

M.net: Because of the increasing complexity of these regulations, do you have more companies coming to you early in the design process? What are the benefits of doing so?

Konieczny: Yes, we currently have multiple projects that are CAD files, napkin sketches or prototypes that have undergone initial design reviews. In our reviews, we are looking at their design from electrical and mechanical aspects and examining how those relate to the standards. This early intervention can mitigate many non-compliances, failures and other regulatory barriers they had not even considered.

It seems as though the days in which we were a “drive-thru” testing lab are long gone. In the early days of the second edition of the IEC standard, companies would drop off their products and return three weeks later for their test reports. Now, it is an open relationship from beginning to end, where we work back and forth with clients on a daily basis to test and certify their products for market entry.

Shortcuts can be costly in terms of time and revenue. Some companies have said that due to difficulty in meeting the requirements of standards and unplanned product re-designs, they were actually at risk of shutting down. Through early intervention and planning, companies can save time and money, increasing a product’s speed to market and ROI. 

Todd Konieczny is assistant chief engineer for the Americas Region and also serves as the technical manager for the medical division. He has also been the corporate laser safety officer for Intertek North America for six years. Todd has 14 years of experience in safety compliance testing, including nine years of medical product compliance testing. During his time at Intertek, Todd has helped numerous clients gain worldwide certification for their products to CSA, CENELEC EN, IEC and UL standards.

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