A Thema expert answers some questions on the topic of Medical Devices quality.

Why improve the quality of Medical Devices?

In developed countries, we are witnessing a progressive ageing of the population: the average life span is increasing and life-threatening diseases are becoming chronic.
Consequently, there is a growing need to invest in research into cutting-edge technologies and new clinical applications for Medical Devices that are increasingly effective, high-performance and safe for patient health.
The medical device industry is experiencing more and more renewal and growth every year.

Manufacturers therefore have a great interest in improving the quality of the design, production and distribution of their devices with considerable advantages:

  • cost reduction;
  • high competitiveness and speed of market access;
  • improved relations and relationships with the relevant authorities.

What are the minimum skills required to improve the quality of the biomedical product?

The answer can be summarised in five points:

  1. Knowledge of the regulatory and legislative context;
  2. Know the processes of your organisation and external organisations with which you need to interact;
  3. Making the device safe;
  4. Demonstrate the effectiveness of the device’s performance;
  5. Apply a streamlined yet effective and comprehensive design process to produce, distribute and market a quality product.

How does European regulation affect the quality of Medical Devices?

The MDR (EU) 2017/745 comes into force with binding force without the need to be transposed into the national laws of the Member States. Each Member State may also introduce, by specific laws, restrictions additional to those prescribed in the regulation. Compared to the previous directives (MDD/AIMDD), and concerning the concept of quality and conformity of Medical Devices, the MDR:

  • reinforces the concept of demonstrating compliance with clinical data;
  • consolidates the link between risk analysis, pre-clinical evaluation and clinical evaluation of devices, and post-market surveillance (PMS);
  • strengthens the concept of device traceability with the creation of the UDI system;
  • introduces new requirements;
  • introduces the Common Specifications (CS);
  • introduces economic operators and defines their obligations;
  • defines the responsibility of the Responsible Person for Compliance (RPC);
  • provides for the issuing of new standards and guidelines.

How much does the MDR (EU) 2017/745 influence the design phase of Medical Devices?

The MDR Regulation has a major impact on the design of Medical Devices. First of all, for a CE PoG MDD/AIMDD certificate to remain valid (Art. 120, p 3 MDR) there must be no significant changes to the design and intended use of the device.
In addition, the general safety and performance requirements must cover the design and manufacturing stages of the products in such a way that their use does not compromise the clinical condition of patients, the safety and health of users and possibly third parties when used in the manner and for the purposes intended by the manufacturer.
As regards safety and risk management, new risks are introduced to be taken into account, such as cuts, unintentional needle stick injuries, disposal and disinfection.

In addition, it is crucial to harmonise design inputs with applicable regulatory requirements.

  • Regulatory Authorities and Notified Bodies have strengthened compliance requirements to increase transparency and ensure the quality and effectiveness of Medical Devices.
  • With stricter requirements and considering the increased focus on patient safety, Medical Device Manufacturers must establish processes to achieve compliance through device identification, clinical data collection and improved labelling;
  • The use of a unique device identification (UDI) system supported by a centralised database will promote the traceability of each device and in turn maintain quality standards.

What are the international standards that promote product quality?

EN ISO 13485:2016 is the Standard that specifies the requirements for a quality management system capable of producing Medical Devices that comply with the requirements and put patient safety at the centre.
Its main purpose is to ensure consistency in the design, development, manufacture, storage and distribution, installation or maintenance and disposal of Medical Devices. The adoption of this standard provides manufacturers with a practical basis for addressing both the regulations of different countries and their responsibilities, as well as demonstrating a clear commitment to the safety and quality of Medical Devices.

Also crucial are ISO 14971 and ISO TR 24971, which introduce the following important changes:

  • new definitions;  
  • more details of production and post-production activities, regarding the entire product life cycle;
  • update of risk control measures;
  • revision of the definition of harm;
  • cybersecurity;
  • need for a policy to establish criteria for risk acceptability.