Document Type

Article

Publication Date

2022

Course

DAN Management and Organizational Studies 9330: Project Management

Description

Executive Summary

As a business grows, there is pressure to expand into new markets, which led to this review. This report is connection with a company that aims to meet the MRI testing needs of its clients. The purposes of this review are (1) to assess the requirements for CE labeling certification and (2) to evaluate the European and the international markets.

Purpose 1: Requirements for CE certification

To obtain CE labeling, there is a need to follow the procedures outlined in the Measuring Instruments Directive. This includes meeting the essential requirements of reproducibility, repeatability, discrimination and sensitivity, durability, reliability, suitability, protection against corruption, information to accompany the instrument, indication of result, further processing of data, conformity evaluation, and allowable error.

After these essential requirements are satisfied, the following technical documentation must also be met:

  1. A description of the measuring instrument and the manufacturing process.
  2. A description of electronic devices, including drawings, diagrams, flow diagrams, software characteristics and operation (if applicable to the product).
  3. A list of the harmonized standards and/or normative documents (Article 14 in the CE Directive) and the applicable references.
  4. An explanation of the solutions and other relevant technical specifications done to meet the essential requirement.
  5. A result summary of the design, calculations, and examinations conducted for the product.
  6. An EU-type examination certification of the measuring instrument with parts identical to the proposed design of the product.

Furthermore, all of this would need to be verified by a notified body, so that a declaration of conformity can be made. After which, the CE label can be attached to the business’ product and the product would be ready to enter the European Economic Area's (EEA) Market. It is important to note that there are multiple applicable CE directives to a single product. Thus, based on our analysis of how CE Labeling links to the business’ product, we recommend the following course of action:

  • Revisit the 24 CE directives and identify any other possibly relevant directives for the business’ product. This allows for a preliminary overview of the work required for CE certification.
  • With the CE directives identified, review the specific steps involved for completion of each directive. This review should follow a similar structure and sequence of steps that have been outlined in the analysis of the Measuring Instrument directive in this report. Through completing these steps, it will enhance future understanding of the time commitment required to obtain CE labeling. This will also prepare the business’ team to assemble the appropriate experts, in order to complete the essential and technical documentation.
  • Due to the complex, overlapping nature of the essential and technical documentation, it is a good idea to look over the flow charts provided in Appendices 3B, 3D, and 3E. This allows the business to gain a consolidated understanding of the steps involved in the completion of this CE directive.
  • It is important to contact and secure a notified body early on to facilitate completion of CE certification in a timely manner. This is because the Measuring Instruments directive requires completion of Module H, for the technical documentation, and this module requires a third-party notified body for CE assessment.
  • Allocate the same product experts to review both the essential and technical documentation. Due to the overlapping nature of these two parts, this approach will minimize discrepancies and promote efficiency in completing the documentation.
  • Harmonized standards should be used to satisfy the relevant essential safety requirements of the measuring device directive. Although it is not required to buy Harmonized standard directive documentations, it would be beneficial because European authorities use these documents to determine whether a product meets the essential requirements. Use of these documents can, thus, help avoid possible technical disputes over compliance because the essential requirements can often be vague and open for interpretation.
  • Since the business is the manufacturer of an MRI probe, a technical file should be created and stored for at least 10 years. This is necessary because it demonstrates the MRI probe’s compliance with the CE directives. These technical files must also be kept up to date (with all the relevant information) in the event that an enforcement agency challenges its compliance with the directives.
  • There is a need to continuously observe the updated CE labeling regulatory requirements. This is because CE labeling requirements and the associated European directives and standards are often updated or replaced. In 2016, new CE Directives replaced the previous versions of the directive which required manufacturers, distributors, and importers to comply with the new requirements. Specific changes to the regulatory requirements will require the business to retest the probe and to update the technical documentation to assure compliance with the most recent CE guidelines.

Purpose 2: Market Analysis

Upon initial evaluations of the competitive landscape of the EEA, it is clear that there are some opportunities and threats to entering the EEA market. Some of its strongest benefits are that the industry is well developed, well funded, and growing due to an aging demographic. The European Medical Device Market accounts for 33% of the Global Market. The EEA is also home to over 27,000 medical technologies businesses. As well, it can be noted that Germany, France, and Sweden–who are part of the EEA–are world leaders in healthcare innovation. However, some of its biggest weaknesses are that there is a complex and unorganized changing legal environment that surrounds the medical device regulations. This results in a time and resource-intensive process of bringing a new product into the EEA market. Due to these weaknesses, other international markets were analyzed, and the Asian-Pacific market appeared promising. The Asian-Pacific market accounts for 60 percent of the world's populations and its medical industry is expected to grow to 133 Billion dollars in 2020 and will continue to increase by 6% every year that follows. As such, the Asian-Pacific region can be labeled as the fastest growing medical device testing market, which provides the business a promising opportunity to expand.

As a result of our analysis of European and international markets, we recommend that the business implement the following recommendations:

  • Continue monitoring the European Market and conduct a cost-benefit analysis for transitioning operations to the EEA. Due to the unknown short-term and long-term effects of Brexit and COVID-19, and the stagnation of the EU economy, the future perspectives and stability of the European Market are unclear and must be further explored.
  • Conduct comprehensive market research on the Asian-Pacific Region, particularly the heterogenous legal environment, in order to have a holistic understanding of the competitive landscape of the region for this business. The Asian-Pacific region is rapidly expanding its medical device manufacturing sector. Coupled with an expanding aging population and an increased demand for medical technologies, the Asian-Pacific region presents a favourable business expansion opportunity.

Download

Share

COinS