EU rules on medical devices

The EU has produced new rules on medical devices to enhance patient safety and modernise public health.

There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.

The new Regulations will help to ensure that all medical devices – from heart valves to sticking plasters to artificial hips – are safe and perform well. The new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.

For more information on the new rules about medical devices on the europa.eu website

Blood management

The European Commission has produced two new guides about blood management:

  • Building national programmes of patient blood management (PBM) in the EU – a guide for health authorities
  • Supporting patient blood management (PBM) in the EU – a practical implementation guide for hospitals

To download these guides on patient blood management from the ec.europa.eu website

25 Years of Protecting our Health

Since 1992 when the Maastricht Treaty specifically stated that ‘The community shall contribute towards ensuring a high level of human health protection’ the EU has been protecting our health.

It has helped national governments to make healthcare more accessible and efficient, provided scientific advice and data, financed local and cross-border health projects and promoted investments in innovation, research and training.

Current challenges include:

  • Guaranteeing accessible, efficient and resilient healthcare
  • Investing more in innovation, research and eHealth
  • Tackling antimicrobial resistance
  • Promoting innovative health products and technologies
  • Preparing for new global health threats

To download the infographic on 25 years of protecting our health from the ec.europa.eu website

Medicine packaging

Since 2001, EU rules have required the medicines we buy in the EU to contain a package leaflet which should provide us – the user, with clear information on the medicines we are taking – including the name of the product and the manufacturer, therapeutic indications, dosage, shelf life and adverse reactions.

The Commission has recently put forward recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.

To read the recommendations on improved medicine packaging on the ec.europa.eu website

Health care without harm

Pharmaceuticals in the environment represent a global pollution problem – over 631 different pharmaceutical agents (or their metabolites) have been detected in at least 71 countries covering all continents. Pharmaceutical residues have been detected in surface water, sewage effluents, groundwater, drinking water, manure, soil, and other environmental matrices. Antibiotics in the environment can promote the development of antibiotic-resistant pathogens – a major global health threat. Also, little is known about the effects on humans from continuous, long-term exposure to low concentrations of pharmaceuticals. Pharmaceutical substances are often engineered so
that they remain unchanged during their passage through the human body; unfortunately this stability means they also persist outside the human body and, as a consequence, can build up in the environment. Several studies have confirmed that medicines pose environmental risks, and that concentrations found in the environment can have detrimental effects on aquatic systems and wildlife.
The Dutch organisation – health care without harm Europe – has produced a report outlining what steps are being taken in Europe to reduce anti-microbial resistance (AMR) and offers opportunities for countries to work together on this shared problem.
To download the summary report on health care without harm from the ec.europa.eu website

Risk assessment in the EU

The EU has produced an infographic to show how the EU’s Scientific Committees assess risks. It not only shows in a clear and concise way how the Committees function but also provides concrete examples of how their work impacts EU legislation.
To download the infographic on Risk Assessment from the ec.europa.eu website

Pharmacovigilance

All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored to ensure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. This monitoring is called pharmacovigilance.

Pharmacovigilance activities include:

  • Collecting and managing data on the safety of medicines.
  • Looking at the data to detect “signals” (any new or changing safety issue).
  • Evaluating the data and making decisions with regard to safety issues.
  • Pro-active risk management to minimise any potential risk associated with the use of the medicine.
  • Acting to protect public health (including regulatory action).
  • Communicating with and informing stakeholders and the public.
  • Audit, both of the outcomes of action taken and of the key processes involved.

For more information about pharmacovigilance on the ec.europa.eu website

Strategic investments for the future of healthcare

National health systems in the EU face common challenges: ageing populations and a rise of chronic diseases leading to growing demand for healthcare; shortages and uneven distribution of health professionals etc. Furthermore, (public) financial resources available for health are constrained. Today’s health systems are in need of reforms to
tackle these challenges. New care models, which support a shift from hospital-centred to more community and integrated care approaches, are a crucial part of the reforms to improve the efficiency and sustainability of health systems.
Earlier in 2017, the Commission, in cooperation with the European Investment Bank (EIB), held a seminar to discuss new forms of investment for innovative forms of healthcare. Over 100 delegates participated in the event, from the public and private sectors: Member States authorities, healthcare managers and service providers, as well as investors active or interested in the health sector.
This led to the report ‘Strategic investments for the future of healthcare’ which details the investment plan for health within the EU.
Download Strategic investments for the future of healthcare from the ec.europa.eu website

Taskforce to take Health and Digital policies further

Europe faces a major challenge with the sustainability and quality of health and care provision, as a consequence of demographic change and improvements in medical treatment. Public expenditure on health and long-term care has been increasing over the last decades in all EU Member States, and is expected to rise even further as a consequence of an ageing population. In 2015, it accounted for 8.7% of GDP in the EU and could reach up to 12.6% of GDP in 2060, according to a recent EU report.

Digital technology can improve health and care provision, allowing citizens to live longer and more healthy life years (HLYs) and it can help in innovating the way we deliver and receive health and care services. The European Commission has set up a task force bringing together technology and health policy makers in order to put the citizen at the centre of health and care re-design.

For more information about the taskforce to take health and digital policies further on the ec.europa.eu website

900 medical teams to connect across Europe for the benefit of patients

European Reference Networks (ERNs) are unique and innovative cross-border cooperation platforms between specialists for the diagnosis and treatment of rare or low prevalence complex diseases.

In 2017 24 thematic ERNs, gathering over 900 highly specialised healthcare units from 26 countries, will begin working together on a wide range of issues, from bone disorders to haematological diseases, from paediatric cancer to immunodeficiency. Joining up of EU’s best expertise on this scale should benefit thousands of patients with diseases requiring a particular concentration of highly specialised healthcare in medical domains where the expertise is rare.

For more information on European Reference Networks on the europa.eu website