background image

Medical Device Regulation: Your technical documentation determines whether you receive authorization

The Medical Device Regulation (MDR) assigns technical documentation a much more important role as part of all control processes. It is intended to prove the compliance of the medical device so that it can receive the CE mark. If the device is allowed to carry this label, the documentation must be kept up-to-date at all times so that it can pass a random inspection.

If technical documentation does not meet the new requirements, the certification of the medical device may be at risk.

Thus, this article will explain to you which adjustments you can make to comply with the new requirements for technical documentation. Below you will find an overview of the most important changes that were adopted in May 2017 and will take effect on May 26, 2021.


The sword of Damocles falls on May 26, 2021 – not all medical device specialists are equally prepared

From the redefinition of medical devices to the expansion of technical documentation tasks, the MDR has burdened companies with multiple regulations governing medical technology. However, it has not sufficiently clarified the conditions for their timely implementation.

The Medical Device Regulation goes into effect on May 26, 2021, and a separate regulation on in-vitro diagnostics will go into effect exactly one year later on May 26, 2022. However, not all medical devices have to be (re-)certified by these deadlines.

Certifications are valid for 5 years from the date on which the notified agency issued them. Under the prescribed transition period, certifications from the time before the law was passed still remain valid. For example, a certification dated March 15, 2017 will still expire on March 14, 2022.

For certifications that were issued since the enactment of the law on May 26, 2017, their period of validity is restricted to the ultimate expiration date of May 27, 2024. That means that a certification that is issued around April 2021 will only be valid for 3 years because of this ultimate expiration date. Its purpose is to ensure that the requirements that have already been demanded but that cannot yet be implemented are promptly made up for. The Johner Institute has performed a detailed study of the periods of validity.

The way that the MDR has redefined medical devices can be seen in such as examples as software products and refrigerators that are used to store medical samples. Whether your device must now meet deadlines for certification depends on the new definitions adopted together with the MDR.

Another deadline concerns the outer packaging of medical devices. If distributors in certain countries want to sell other package sizes, they must inform their notified agency 28 days before the market launch. They also must comply with special labeling requirements and prove that they meet certain rules, such as, for example, for quality management. You can learn more about this in the Pharmazeutische Zeitung.


The new tasks for technical documentation and other texts for medical devices

The Medical Devices Regulation has made technical documentation an integral part of quality management. The first fundamental innovation is that manufacturers must keep the documentation up-to-date for all reader groups, including documentation that is understandable to laypeople that is intended for patients.

  • This requires terminology management that grows with every change to the medical device.

Manufacturers must demonstrate that their medical device is compliant in the technical documentation. The compliance assessment is carried out on this basis by the responsible testing agency. Once the device is ready for the market, the documentation must always provide information about the current status. Ultimately, it provides the proof of authorization and the starting point for unannounced spot checks in the form of spontaneous audits.

  • A uniformly organized document structure ensures that you meet the requirements of the legislation. To ensure this, it is advisable to follow the rules of the Summary Technical Documentation (STED). Published by the International Medical Device Regulators Forum, it ensures an easily transparent text architecture that can be quickly edited as needed.

Patient information, device labels, and other types of text that are aimed at laypeople must be written at a correspondingly simple language level. The regulation says in Article 18: "The information shall be written in a way that is readily understood by a lay person".

  • Professional medical translators know how to adapt texts to the requirements of different target groups. And with software, a readability index can also be calculated for large amounts of text.

Inconsistent versions, which can progressively lose clarity over the course of the device life cycle, are also problematic.

  • A terminology database with recognized, standardized language definitions as well as an internationally standardized symbolic language and translation memory ensure that the notified agency receives a translation that is compliant with conventions and will pass inspection. It provides unambiguous and consistent expressions and formulations for the entire life cycle of a project. Above all, it lets you keep track of all revisions.

By definition, there are now more products that qualify as medical devices. For example, a refrigerator that is used to cool medical samples is now covered by the definition of the MDR. The Medical Device Regulation now also governs more types of text, such as, for example, an implantation card for patients. For these reasons, companies are faced with a larger amount of text and more organizational expenditures.

  • This is where a permanent translation partner can really help out. Together with responsible managers at the company, it can help you to manage medical translation projects and also handle unplanned revisions.

Much can be done to reduce turnaround time. For example, you can have the notified agency issue you a deviation report if you need to update a document inventory. It shows you the text in need of adjustment for faster processing.

In order to get a more general understanding, it can provide you with specific explanations concerning the scope of the significant additional work that the MDR requires for medicine and related industries, such as explanations of the legally required changes.


What will change for medical device manufacturers

It is feared that the stricter controls will lead to delays. In the worst case scenario, the delays could affect patients who are in dire need of the devices.

In the long term, the measures of the Medical Device Regulation, together with all subsequent adjustments, should achieve better quality and safety for consumers.


Certification for the entire market

There is no grandfathering provision for medical devices, which is why every device placed on the market must be updated to meet the heightened requirements.


More stringent requirements for notified agencies

The legislature has also made the requirements for notified agencies more stringent. This has made it more difficult for the testing authorities to gain recognition as such and to offer tests for every medical device.


Extended and stricter definition for medical devices

The revised definitions for medical devices, which propose a wider understanding of the term than was used before, should also not be underestimated. Some commonly used products are now regarded as medical devices and have to pass the same strict processes.

A refrigerator, for example, is now considered to be a medical device if it is used to store medical substances. And software in the field of medical technology must also be treated as a medical device depending on its intended use.

Products that are used for the (sterile) cleaning of medical devices also now fall under the definition.


Unique device identification (UDI) for each model

The introduction of unique device identification (UDI) for all medical devices means that ones that are currently in circulation to be traced back to their manufacturer. This innovation was directly adopted in response a triggering incident for the new legal regulations: a Parisian silicone implant that burst in the wearer's chest could not be traced back to a responsible manufacturer because there was no origin information about the device in the hospital records.


New classification with stricter risk levels

The Medical Device Regulation provides for a different classification. There are now more classes as well as other assignments. Overall, the risk ratings have become stricter. In order to continuously monitor safety, the EU also requires manufacturers to introduce a risk management system that is embedded in a quality management system.


New quality management system

The device numbers require that every company adopt a new quality management system. Thanks to this quality management system, manufacturers can respond properly to random test procedures, which request device-specific evidence, among other things. Each manufactured medical device must remain registered in the EUDAMED database for 10 years after being placed on the market, and implants must remain so registered for 15 years.


A responsible manager at every company

In the future, a responsible manager who must be employed by the company will be responsible for ensuring compliance with the regulatory and organizational guideline requirements of the MDR.


Clinical trials: Analyses are only provided on request

Stricter criteria now also apply to the evaluation of clinical analyses and trials, which is why manufacturers have to take a much more differentiated approach to the selection of equivalence analyses. Because comparative studies of similar devices are no longer sufficient, the MDR stipulates that they must prepare or commission their own studies more often than before.


Unannounced audits

In addition, test centers can carry out unannounced audits at medical technology companies and their suppliers at any time. That is why it is important to work with certified suppliers. Suppliers that can be checked without needing to receive notice also include language service providers, such as medical translation agencies.


Annual reports

Manufacturers must also prepare annual reports based on quality management.


Side effects of the MDR: Delays

There has been little advanced preparation for the introduction of the legislative measures. In the short time it took to pass the law, too few notified agencies received authorization, and too few of them were qualified to test the entire range of medical devices. The situation is exacerbated by the Coronavirus pandemic, because fewer audit appointments can be made.

The EUDAMED database has not yet been set up to perform all of its intended tasks. There are also pending legal acts that are intended to provide further clarification of aspects of the MDR requiring interpretation so that they can also be complied with. The guidelines that are supposed to provide information to address the ambiguities in the interpretation have not yet been drawn up, and the expert committees that are supposed to evaluate high-risk devices have not yet been established.

With this in mind, it can be seen that time is of the essence, and any further costly delay should be avoided. It remains to be seen how quickly the notified agencies will process registrations for certifications and how the applicants will manage the entire process changeover. One order of the day seems to be to buy time.


Be well prepared with effective translation management

Is your medical device about to be launched on the market, and do you need to create or revise technical documentation and also submit other texts to the notified agency? Our technical experts in the Medical Technology Department can provide you with timely medical translation services into your desired languages.



No Comments

Write comment

* These fields are required