The path to successful product certification in medical technology

Each country has its own regulations regarding the requirements for placing medical devices on the market. While there are still a few countries with almost no monitoring, in most countries a number of laws and regulations must be complied with, often referring to national or international standards and guidance written by the relevant body.

With our experienced team, we find the necessary regulations and identify the applicable standards for the foreseen target market.

For example, in Europe not only do the MDR requirements have to be fulfilled, but there are others to be considered such as the EMC directive, Reach and Rohs, or perhaps the Machine directive.

For material compatibility, for example, there are the ISO 10993 and ISO 18562 series of standards, to be applied depending on the type of device. The US health authority has also published its own guidelines on how it would like the application of the standards to be understood.

ISO 13485 is usually used as the basis for the quality management system (QMS), and a corresponding certificate is considered a prerequisite in many countries. However, since each country has its own ideas, especially in the area of reporting requirements, the QMS must be aligned and expanded to the target markets.

As part of the quality assurance measures in a QMS are internal audits, which are carried out by an appropriately trained and competent person. They serve to uncover potential for improvement and non-conformities internally before the external auditor does. If our customer lacks the necessary personnel, we can either train them or provide the auditor and take over the internal audit completely.

To best prepare for an audit by a notified body or authority, we also perform mock audits. In this case, our employees take on the role of the notified body or authority and go through a complete audit.

An important starting point in product development is the definition of Intended Use (or Indications for Use in the USA) to determine what the device is to be used for. Do I want to use it to diagnose or treat something? Do I want to use it to relieve pain or make sure pain doesn't happen in the first place? Who will use the device, a layperson like the defibrillator at the train station, or is the user a professor with many years of experience in cardiac surgery? Will the device be used outside in the rain and snow at night, like the defibrillator at the train station, or will it be used in the best air-conditioned and illuminated operating field? All these are questions that have to be defined at the beginning and which are decisive for the whole project. We help to define these questions in a way that further steps like device classification etc. can be derived from them.

Once the foundation has been laid, specifications and the test plans based on them must be drawn up. Their traceability is another important building block in the approval of a medical device.

Usability or Human Factors Engineering as it is called in the USA, is a process that does not start with the final validation, but early on with a clean and well-thought-out usability specification that is tested early on during development.

Last but not least, the approval strategy determines the markets in which the product can be sold and when. The most obvious market is not always the best one to bring your product to market. Individual countries have very different processing times for approval applications, which can vary in months.

The proof that the medical device meets the user requirements but also the requirements from laws and standards is an unavoidable activity in every development. As far as possible, the same people who developed the device under test should not test it. Traceability plays a central role here.

Depending on the product type and target market, there are different requirements for the test conditions: Is a manufacturer's test sufficient? Is an accredited test laboratory required? Or even a CB certificate?

Even if a manufacturer's test is sufficient, there are minimum quality requirements for test performance and recording of results to ensure that test results are reproducible. Accordingly, test equipment and measuring instruments must be maintained calibrated traceable to national standards.

Test laboratories that are accredited or test in the CB procedure of IECEE usually have long lead times and corresponding prices, a pre-compliance test in our own test laboratory helps to ensure that after the long waiting period, the tests are successful and reduce costly, iterative repetitions.

Notified bodies and authorities cannot check the medical devices, they have to rely on the manufacturer's documentation. If the documentation is incomplete, not self-explanatory, or contradictory, this leads to queries and delays in market approval and thus delays the ROI (return on investment).

It is therefore imperative that the documents are prepared in accordance with the target market and submitted in the form required by the regulatory body or authority. The form may differ significantly, for example, from a European notified body to the US FDA, even if a large part of the information is identical.

Authorities, legislators, and notified bodies have published guidance and recommendations that must be followed.

Once the documentation is complete, the next step is to submit it to the right body, which is quite a challenge, especially in Europe with the various notified bodies. The cost of submission as well as the waiting and processing time can vary significantly depending on the target market and change over time. Whereas until a few years ago approvals in Europe were quicker and cheaper to obtain than in the U.S., today the U.S. FDA stands out with clearly calculable costs and a targeted turnaround time.

The approval strategy with the prioritization of target markets thus has a significant influence on when the first products may be sold and thus on when the return on investment can be worked on.

In addition to medical device approval, there are other certifications and approvals in many markets that should not be overlooked. For example, more and more medical devices today have a radio module such as Bluetooth or WLAN built in and therefore require approval and/or certification of the radio module in addition to the medical device approval. In the USA and Canada, electrical safety certification by an NRTL is required in many places. These side issues must not be forgotten as part of the approval strategy, as they can delay market entry by months.

After approval, there are further tasks to keep the device on the market:

1. Market monitoring: Both the feedback on one's own product and the incidents of competing products must be monitored. Can an incident happen again? Is it reportable? Where does it have to be reported? Depending on the case, a device in the field may need to be updated or recalled.
2. Notified bodies as well as authorities and customers can and will audit manufacturers, both announced and unannounced. This is to ensure that approved devices continue to be produced in accordance with the approval and that manufacturers comply with their requirements. Deviations found during such audits must be dealt with within a reasonable time.
3. Renewals of approvals: not only when the product is adapted, depending on the market, the device must be regularly re-approved at intervals of a few years or at least an extension of the approval must be applied for. This period should not pass unused.