Impact of the new European medical device regulation: a two-year comparison

General procedure

This non-experimental, observational study was designed as a web-based, cross-sectional, repeated survey to compare experiences and opinions regarding the acceptance and feasibility of the MDR among workers in the orthopaedic aids industry in Germany. Data collection took place in two phases: before the MDR became applicable in 2021 (initial survey, InS) and almost two years after in 2023 (repeat survey, ReS).

The questionnaire was evaluated by two independent external reviewers, based on which the wording of some of the questions was changed and the structure adjusted. Additional minor edits were made after the initial survey was pretested with three orthopaedic technicians.

Data collection

Surveys were completed by workers in the orthopaedic aids sector to investigate the current status of the application of the MDR (mandatory as of May 2021) and the expected consequences. Data were self-reported and collected automatically and anonymously by SoSci Survey. The surveys were completed online. The initial survey was open for approximately six weeks in January and February 2021. The follow up survey was conducted two years later. It was also accessible for about six weeks in February and March 2023. The self-administered, web-based survey was distributed to the approximately 3,000 health care supply stores in Germany.

Participants

Participants were distributors and manufacturers of orthopaedic aids, primarily exo-prosthetics and orthotics, as well as employees of health care supply stores in Germany. The call for participation was distributed via various media channels, such as the 360° specialist portal of the Bundesinnungsverband für Orthopädie-Technik, the MTD-Instant newsletter and others. In addition, an email containing a hyperlink to the survey and a cover letter explaining the purpose of the study, summarizing the content of the questionnaire, and providing contact information was sent to health care supply stores in Germany. Two reminders with the same structure as the initial email were sent electronically approximately three and five weeks after the first invite. Subjects were informed that participation was voluntary, and that no financial compensation was provided for completing of the survey.

Instrumentation

A web-based questionnaire was developed using the SoSci Survey tool, taking into account previous surveys [10, 11]. Each questionnaire took approximately 5–10 min to complete. In preparation for the repeat survey, the first questionnaire was adapted to the experiences of the initial survey. Some of the questions were omitted or modified as they related to the period before the MDR became applicable. Due to the adjustments made, the repeat survey contained 15 closed-ended questions, five fewer than the initial survey. The questions, which were the same in both surveys, were divided into four main areas, see Table 1.

Data analysis and statistics

Upon completion of the survey, the data were exported from SoSci Survey and then analyzed using IBM^® SPSS^® Statistics (Version 27) for Windows. Data, which were categorical only, were described using frequencies and percentages to define the proportions of the sample. The median was reported for all Likert scale questions. Open-ended response options were not formally analyzed. Rather, selected quotes are included in this text to support the findings. Responses from the repeat survey (N=179) were then compared to responses from the initial survey (N=105) using Mann–Whitney U tests to assess differences in views of the orthopaedic aids industry since the MDR’s date of application. In order to analyze the effect of company size on different response distributions, Chi-square tests were used to identify possible correlations. When expected cell frequencies were below 5, an exact Fisher test was used instead of a Chi-square test. A probability of p<0.05 was set as being statistically significant.

State of knowledge

Respondents’ knowledge of the regulatory changes brought about by the MDR has not improved since the date of application, U=10,490.00, Z=−0.420, p=0.675. Both the companies surveyed before the date of application (Mdn=3, N=103) and those in the repeat survey (Mdn=3, N=103) reported average knowledge of the new medical device regulation. Nevertheless, all companies have gained some level of knowledge about the amendments to the regulation since the date of application. In the initial survey, almost one in 10 companies (9 %) reported to have no knowledge, whereas the repeat survey showed that all companies have some level of knowledge, albeit poor.

Challenges due to the MDR

The implementation of the MDR is perceived as challenging. This assessment was not influenced by the time of the survey, U=3,206.50, Z=−0.893, p=0.372. Prior to the application of the MDR, more than half of those questioned (55 %) described the implementation of the MDR as very or extremely challenging for their company. Almost two years later, 44 percent of the respondents still described the implementation in the same way. Company size did not affect this assessment, Fisher’s exact test: p=0.617, N=88 (InS); p=0.317, N=78 (ReS).

The MDR poses a number of challenges for companies. This is evidenced by the fact that, when asked to identify the greatest challenges posed by the MDR, respondents named an average of 3.5 challenges. Additional workload for technical documentation (InS: 73 %; ReS: 86 %), increased resource expenditure and cost (InS: 64 %; ReS: 71 %), and lack of clarity regarding the new requirements of the MDR (InS: 59 %; ReS: 54 %) are among the top challenges for companies in the orthopaedic aids industry, as shown in Figure 1. Product-specific regulatory requirements (InS: 47 %; ReS: 35 %) and the implementation of a quality management system (InS: 39 %; ReS: 30 %) also cause problems. Difficulties in implementing quality management systems were reported significantly more often by smaller companies with fewer than 50 employees, χ²(1, N=277)=4.38, p=0.036. In particular, the additional workload associated with the Unique Device Identification (UDI) system was cited as a major challenge following the application date of the MDR (InS: 27 %; ReS: 49 %).

Figure 1:

Main challenges faced by companies in the orthopaedic aids industry as a result of the MDR; respondents who answered “Others” are not shown.

Risks

The implementation of the MDR poses different types of risks for businesses in the orthopaedic aids industry. Nearly all companies (InS: 90 %; ReS: 89 %) anticipate an increase in costs or have already experienced higher costs, see Figure 2. A reduction in their product portfolio is also feared by many respondents (InS: 46 %; ReS: 33 %). In addition, about one-third of those surveyed (InS: 28 %; ReS: 30 %) indicated that they are having difficulty bringing innovative products to the market because of the MDR. Some companies (InS: 18 %; ReS: 14 %) said they would have to reduce or have already reduced their research and development (R&D) activities in order to meet the increased requirements of the MDR within their operations, shown in Figure 2.

Figure 2:

Major risks associated with the MDR according to survey respondents, ranked in descending order; respondents who answered “Others” are not shown.

Fear of having to cut jobs as a result of the MDR has decreased since the date of application. In the initial survey, 14 percent of respondents said they expected job cuts. About two years later, the figure was only 5 percent, see Figure 2. Smaller companies were particularly concerned.

For some companies, the increased requirements resulting from the MDR are so extensive that it is considered to be an existential threat. In the initial survey, one in 10 companies (10 %) stated that their organization’s existence was at risk as a results of the MDR. Two years after the date of application, this figure had risen to a quarter of those surveyed (25 %).

Potential improvement caused by the MDR

The core of the MDR is to better protect public health and patient safety. Prior to the effective start date of the MDR, most respondents (52 %) considered the goal of increased patient safety to be the greatest benefit of the new regulation, see Figure 3. The repeat survey showed that the assessment of the potential for improvement due to the MDR has changed significantly, χ²(5, N=256)=122.94, p<0.001. The effect size Cramér’s V=0.693 is interpreted as a strong association.

Figure 3:

Greatest opportunities participants see in the new MDR, ranked in descending order; respondents who answered “Others” are not shown.

Now, almost two years later, the majority of respondents (73 %) said they saw no potential for improvement in the MDR for their company. In fact, respondents spoke of “deterioration”. Participants experience the MDR as “an over-administration in many different areas, which makes smooth working difficult”. In the initial survey, only about one-fifth of the respondents (21 %) were of this opinion. An improvement in patient safety is seen by only 23 percent of the respondents in the repeat survey. Competitive advantages were cited by nearly one in five participants (24 %) in the first survey. Nearly two years later, only 5 percent saw this benefit from the MDR.

Quality management system

For medical device manufacturers, the quality management system is mandatory. With entry into force of the MDR, the importance of quality management has increased. Even manufacturers of class I devices are now obliged to implement a quality management system. According to the MDR, manufacturers are required to “establish, document, implement, maintain, keep up to date and continually improve a quality management system” appropriate to the risk class and type of device (Art. 10, para. 9 MDR).

With the MDR coming into effect, the distribution of MDR-compliant quality management systems has shifted significantly, Fisher’s exact test, p<0.001, N=278, see Figure 4. Before the date of application, most respondents (51 %) had developed a compliance strategy and were in process of making the necessary adjustments. Only a quarter of companies (25 %) had a fully MDR-compliant quality management system at the beginning of 2021. However, two years later, nearly half of the participants (45 %) reported having a fully MDR-compliant quality management system. Overall, more companies in the initial survey reported that they need to develop an appropriate strategy to comply with the quality management system (InS: 8 %; ReS: 2 %), did not plan to change their quality management system (InS: 8 %; ReS: 5 %), or did not have a quality management system at all (InS: 5 %; ReS: 6 %) compared to the repeat survey.

Figure 4:

Distribution to the question “To what extent is your quality management system already MDR compliant?”; respondents who answered “Not specified” are not shown.

The introduction of MDR had no effect on whether and how the quality management system was certified, Fisher’s exact test, p=0.667, N=262. The majority of companies with a quality management system had it certified to either DIN EN ISO 13485 (InS: 52 %; ReS: 49 %) or ISO 9001 (InS: 29 %, ReS: 32 %). Approximately one in 10 companies (InS: 10 %; ReS: 11 %) have not yet had their quality management system certified.

Custom-made devices

People with disabilities are often treated with individualized devices tailored to their needs – so-called custom-made devices, such as orthoses, prostheses or functional aids. Patient-specific care is therefore essential in the provision of orthopaedic aids. According to Article 2(3) of the MDR, a custom-made device is “any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs” [12]. The importance of individualized care in the orthopaedic aids industry is reflected in the high number of custom-made device manufacturers. 68 percent of those initially questioned and 75 percent of repeat survey respondents were manufacturers of custom-made devices.

With the introduction of the MDR, there are more stringent regulatory requirements for custom-made devices. The Medical Device Coordination Group (MDCG) states in its Q&A-document that “custom-made device manufacturers must meet nearly all of the MDR requirements” [13]. These mainly relate to quality management, risk management, post-market surveillance as well as clinical evaluation and post-market clinical follow-up. Almost all custom-made device manufacturers (InS: 89 %; ReS: 93 %) were aware of these changes.

To assess the feasibility of implementing the increased requirements, respondents were asked to rate several statements. Comparing the results of the two surveys, it is clear that manufacturers of custom-made devices rate the required regulatory changes as significantly more difficult following the application of the MDR, U=3,836.00, Z=−2.653, p=0.008. In 2021, 66 percent of respondents agreed with the statement “We can meet the increased requirements for custom-made devices under the MDR”. Nearly two years later, only 42 percent agreed.

Because healthcare providers who manufacture custom-made devices are the legal manufacturer, they are required to comply with the MDR. Adequate resources are needed. SMEs, which are common in the orthopaedic aids industry, are often ill-equipped to implement the detailed specifications of the MDR. Financial and human resources are lacking. In the initial survey, many custom-made device manufacturers were convinced that their existing resources were sufficient. Therefore, compared to the repeat survey, significantly more respondents in the 2021 survey disagreed with the statement “We lack financial resources to implement the changed requirements” (Mdn=4 equivalent to “disagree”, N=63), U=2,645.50, Z=−3.683, p<0.001. Almost two years after the date of application, most of the participants stated that they lacked financial resources (Mdn=3 equivalent to “undecided”, N=124). The situation is similar for human resources. Again, significantly more respondents in the repeat survey reported a lack of personnel resources (Mdn=2 equivalent to “agree”, N=142), U=3,519.00, Z=−2.656, p=0.008.

The survey results indicated that most manufacturers of custom-made devices do not have the resources for clinical evaluation. This was confirmed by respondents both before (Mdn=5 equivalent to “strongly disagree”, N=59) and after (Mdn=5 equivalent to “strongly disagree”, N=130) the MDR became applicable, see Figure 5. This may be one reason why most participants reported a need for assistance with clinical evaluation and post-market clinical follow-up (InS: 64 %; ReS: 67 %).

Figure 5:

Response distribution to the statement “We have the resources to perform a clinical evaluation”.

The MDR has also increased the documentation requirements of custom-made devices. In order to comply with these additional requirements, manufacturers will have to invest an additional amount of effort. In the initial survey, more than half of the custom-made device manufacturers (51 %) indicated that they could handle the additional workload for documentation (Mdn=2 equivalent to “agree”, N=65). Almost two years later, the number was significantly lower, U=3,360.00, Z=−3.400, p=0.001. In the 2023 survey, half of the custom-made device manufacturers questioned disagreed with the statement regarding the additional workload for documentation (Mdn=3 equivalent to “undecided”, N=145). This suggests that many manufacturers are unable to meet the increased documentation requirements. Automatic generation of some aspects of the documentation could address these practical difficulties. That this would be helpful was confirmed by respondents both before (Mdn=1 equivalent to “strongly agree”, N=64) and after (Mdn=2 equivalent to “agree”, N=128) the MDR became applicable, see Figure 6.

Figure 6:

Response distribution to the statement “Automatic generation of some aspects of the documentation is helpful”.

Limitations

While this study provides a comprehensive overview of the impact of the MDR on the orthopaedic aids industry, it also has certain limitations. The use of an unvalidated, non-standardized questionnaire may have introduced bias, even though it was developed based on previous surveys. The recruitment process is also a limiting factor. While online surveys have the potential for high response rates, there are biases regarding the audience reached and therefore the adequacy of the information obtained [19]. For example, participants were limited to those who had access to appropriate technology and the technical skills necessary to submit the information correctly. In addition, respondents in this study were limited to the subset of individuals who actively chose to be part of the surveys and were motivated to provide input on the MDR. Another limitation is that the surveys were conducted only in Germany. The results are therefore relevant to the German medical device industry. In order to confirm (or not) the results for Europe, future research should also survey different European member states. Furthermore, only distributors and manufacturers of orthopaedic aids and employees of health care supply stores were surveyed. The orthopaedic aids industry is characterized by small, owner-operated craft businesses that are primarily manufactures of class I and custom-made medical devices. Future surveys should include other sectors of the medical device industry to identify potential differences between them and to gain an overall view of the industry’s experiences and opinions regarding the acceptance and feasibility of the MDR.