Exporting medical and laboratory devices to Europe

Laboratory and medical device export opportunities in Europe

Several countries in Europe are facing financial problems with regard to their healthcare budgets. Nevertheless, its medical technology sector is ripe with export openings from developing countries. Opportunities in the form of subcontracts is steadily gaining traction across European manufacturing firms and the new trend of end users who purchase directly from the developing countries. For any exporter who can offer cost-effective, innovative, and sustainable products, country data shows that success is just around the corner.

Social market driver: Growing ageing population

Europe is the most aged population and is ageing faster than any population in the world (except Japan) – a result of a low fertility rate and longer life expectancy.

A gradually increasing senior citizens section of society is an important market driver for the healthcare industry. A growing need for healthcare products and health centres will be evident with a focus on products towards improved lifestyles.

Blood pressure equipment and self-diagnostic units for diabetics will be sold as over-the-counter products. Orthopaedic devices will also be in demand. Retailers should be wise to know that healthcare products are more useful for elderly patients.

Technological market driver: Technology and opportunities

Hospitals wanting to maintain top-notch healthcare standards and innovation continues to secure an important part. These innovations have created market opportunities in the past which include:

  • Robot technology for minimal invasive surgery combined with endoscopic techniques.
  • E-Health: Digital technology for e-prescriptions and electronic health records.
  • M-Health: Mobile health applications and solutions usually in the form of wearable technology to assist in patient data collection and ultimately boost patient care.
  • Development of efficient and inexpensive diagnostic mechanisms in containing epidemics.
  • Replacement of reusable devices with disposable instruments used in procedures and surgery
  • Imaging technology: X rays, ultrasound etc.
  • Nanotechnology application in medical instruments.
  • Replacement of old-school latex with low-protein latex or silicone rubber substitute.
  • Central intravenous catheters pregnant with antimicrobial agents.
  • The booming of medical technology and pharma integration
  • 3D printed and personalised medical devices
  • Introduction and use of mobile medical units for mammography and lithotripsy.

Economic market drivers

Intensifying emphasis on expenditures and efficiency

Several governments are working hard to restrict health expenditure while improving efficiency. This should be the common goal in the areas of product development and value propositions.

Insurance companies

Insurance companies are to increase the price level and reimburse products as agreed in contracts. This will benefit exporters making negotiations between them and insurance companies very important in the market.

Political market driver: Revision of the medical devices directives

The existing 3 European medical devices directives were replaced with two European regulations, to achieve a suitable, robust, transparent and sustainable regulatory framework for the development of safe, effective, and innovative medical devices.

Here are some of the significant changes in the regulations for manufacturers:

  • Prior to approval, a special committee of authorities from EU member states and overseen by the European Commission, will review products and give CE Marking approval post scrutiny.
  • Common technical specifications will be devised for all medical devices by the European Commission
  • A Unique Device Identification (UDI) system that enables the identification of different types of devices will be implemented and the European Databank on Medical Devices (Eudamed) will be expanded.
  • Certain devices will be reclassified as Class III devices, which will require a design dossier.
  • All medical devices are reusable, unless they are scientifically labelled for single use.
  • Reprocessing of a device won’t be allowed in case of a single-use designation.

As these regulations are the same for both EU and non-EU manufacturers, this gives a fair playing field.

All market drivers together make that the import of medical devices to Europe is likely to grow.

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This entry in Europe was updated on 22 May 2021 by specialist.