The impact of the Medical Device Regulation (MDR)

• Improved patient safety
  By setting stricter requirements for the clinical evaluation and monitoring of medical devices, the MDR aims to increase the safety and performance of these products, ultimately benefiting the health and safety of patients. 
• Stricter inspections
  The MDR places stricter requirements on manufacturers and distributors to ensure the quality and safety of medical devices throughout their life cycle. 
• Standardisation of regulations
  By standardising the regulation of medical devices within the EU, the MDR aims to create a more consistent and predictable market for manufacturers and other stakeholders, benefiting the EU internal market.

Classification of medical devices 

Medical devices are classified according to the risk they involve. This classification is important as it determines the requirements for conformity assessment procedures and other regulatory obligations. Classification is generally divided into four main categories: Class I, Class IIa, Class IIb, and Class III. These are ranked from low to high risk.

• Class I (low risk): Non-invasive products such as stethoscopes, crutches, wheelchairs, hoists and bandaging materials, with basic regulatory requirements. 
• Class IIa (moderate risk): Moderate-risk products, such as surgical gloves, with increased requirements for clinical evaluations. 
• Class IIb (moderate-high risk): Products such as blood infusion sets, with even more strict regulations and extensive documentation. 
• Class III (high risk): highest-risk products, such as heart valves, subject to the most rigorous assessments and continuous monitoring.

MSP Medical Products' finished products fall exclusively under Class I. MSP Medical Spare Parts' products fall mainly under Class I.

Impact of the MDR on healthcare providers and manufacturers 

The implementation of the Medical Device Regulation (MDR) has significant implications for both healthcare providers and manufacturers/suppliers of medical devices.

For manufacturers/suppliers 

Suppliers and manufacturers face stricter regulations, including more extensive documentation requirements, more intensive compliance checks, and possible reclassification of products, leading to higher costs and longer product development times.

For healthcare providers 

For healthcare providers, this may result in challenges such as fluctuations in product availability and higher costs, although at the same time the MDR ensures higher overall safety and quality of medical devices.

Other countries and regions and medical device legislation 

Each country or region has its own medical device regulatory authorities and legislation. For example, in Canada, Health Canada is responsible, while in Japan, the Ministry of Health, Labour and Welfare fulfils this role. In the United States, it is the Food and Drug Administration (FDA) that regulates medical devices.

MSP and medical innovation 

Medical device regulations are constantly changing, especially with the focus on technological advances and changing public health needs. At MSP, we produce smarter and more affordable healthcare products and components. Our experience in international medical manufacturing has given us unique competitive insights. Want to know more about MSP or read about Arda Medical's case study? Check out our website or contact us.