Coronavirus: harmonised standards for medical devices to respond to urgent needs

medical equipment

(Marcel Scholte, Unsplash)

This article is brought to you in association with the European Commission.


Yesterday, the Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure. The revised harmonised standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices* such as:

  • medical face masks
  • surgical drapes, gowns and suits
  • washer-disinfectors
  • sterilisation

Stella Kyriakides, Commissioner for Health said: “We must not waste a second in our fight against the coronavirus. With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line – to keep saving lives”.

Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.

The decision to adopt these harmonised standards for medical devices represents an additional measure taken by the Commission to respond to the coronavirus outbreak. Also upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in cooperation with their members made available a number of European standards for certain medical devices and personal protective equipment.

Background

European standards are an essential pillar of a fully functioning internal market. They reduce costs, promote innovation, ensure interoperability between different devices and services, and help companies to access markets.

To support EU product legislation, the Commission can request the development of European harmonised standards to facilitate compliance by manufacturers of the relevant requirements. Once agreed and referenced in the Official Journal of the European Union, these harmonised standards become part of EU law and allow companies an easy and direct access to the internal market for their products, while ensuring a high degree of safety for users and consumers.

European legislation for medical devices also relies on harmonised standards. In particular, under the three current directives on medical devices, there are about 300 harmonised standards conferring presumption of conformity with the legal essential requirements. The Commission and the concerned European standardisation organisations (CEN and CENELEC) continuously work together to update and improve the set of harmonised standards available to economic operators in the EU. In such a common effort to face the coronavirus pandemic, the Commission, CEN and CENELEC have agreed to make a number of harmonised standards for important medical protective equipment like face masks and single-use gloves freely available to those companies that are willing to start producing these items.

the sting Milestones

Featured Stings

Can we feed everyone without unleashing disaster? Read on

These campaigners want to give a quarter of the UK back to nature

How to build a more resilient and inclusive global system

Stopping antimicrobial resistance would cost just USD 2 per person a year

This is how trees could help solve the climate crisis

Humanitarian Aid: EU announces €18.5 million additional package for Latin America and the Caribbean

This is how COVID-19 has impacted workers’ lives around the world

Why financial services can kickstart Africa’s digital economy

New UN report launched to help ratchet up action to combat climate crisis

Measles in Europe: infection rates highest in a decade, says UN health agency

Governments, businesses ‘walk the talk’ for investment in sustainable development: UN forum

Women must be at ‘centre of peacekeeping decision-making’, UN chief tells Security Council

IMF’s Lagarde indirectly cautioned Eurozone on deflation

General Assembly officially adopts roadmap for migrants to improve safety, ease suffering

Financial stability: Commission addresses risks of Libor cessation

European Defence Fund on track with €525 million for Eurodrone and other joint research and industrial projects

How to promote Primary Healthcare to the Young Healthcare Workforce?

Human Resources Information Systems Specialist Trainee – 2013

This member of the banana tree family could help us cut COVID-19 plastic waste

This is what has led to the George Floyd protests in the United States

Scores killed in ‘barbaric’ attack on Mali village, UN chief urges restraint, calls for ‘dialogue’ to resolve tensions

Finnish Prime Minister calls for a more united EU of concrete actions

COP24 negotiations: Why reaching agreement on climate action is so complex

Technology and public healthcare: the basis to fight COVID-19

Connectivity and collaboration in the ICT industry: the key to socio-economic development

Four in 10 indigenous languages at risk of disappearing, warn UN human rights experts

Myanmar: Conflict resolution at ‘total standstill’, military commanders must answer for crimes against humanity

Clean air is good for business

Rule of Law: Commission launches infringement procedure to protect the independence of the Polish Supreme Court

Why ‘video call fatigue’ might be making you tired during lockdown – and how to beat it

Paris, Washington, IMF against Berlin and ECB on money and interest

Antitrust: Commission sends Statement of Objections to O2 CZ, CETIN and T-Mobile CZ for their network sharing agreement

COVID-19 put 1.6 billion children out of school. Here’s how to upgrade education post-pandemic

These 5 start-ups are shaping the future of Africa’s cities

Syria: UN-backed watchdog says chemical weapon ‘likely used’ in February attack

UN rights expert calls for end to ‘purgatory’ of ‘international inaction’ facing Myanmar’s remaining Rohingya

Coronavirus: Commission proposes to ease restrictions on non-essential travel to the EU while addressing variants through new ‘emergency brake’ mechanism

Monday’s Daily Brief: biodiversity and forests, labour and road safety, women’s rights, and fallen UN staff remembered

EU Parliament approves CETA: the EU-Canada free trade deal sees the light in Trump’s gloomy era

What technology changes will 2021 bring? Here’s what business leaders say

Brexit: when the hubris of one man can set the UK, the EU and the entire world on fire

Less than half of EU travellers are aware of EU Passenger Rights

Electronic cigarettes: is it really a safe alternative to smoking?

UN will do ‘utmost to prevent and mitigate any risk of violence’ in DR Congo, pledges Mission chief

IMF – World Bank meetings: US – Germany clash instituted, anti-globalization prospects visualized

‘The clock is ticking’ on meeting the Sustainable Development Goals, says UN deputy chief

EU shapes its ambitious strategy on India

This is why attractive cities do better economically

Why South Africa is on a path of economic renewal

UN rights office calls for action to end ‘repression and retaliation’ in crisis-torn Nicaragua

Vegans in France are using extreme tactics to stop people eating meat

COVID-19 and nature are linked. So should be the recovery.

A Sting Exclusive: “Entrepreneurship in the Coronavirus (COVID-19) era” written by the Vice-President of Junior Enterprises Europe

Myanmar military committed ‘routine, systematic’ sexual violence against ethnic minorities, UN experts find

UK economy in dire straits: leading banks now officially plan to Brexit too

Marking international day, UN experts call for urgent action to end racial discrimination, in wake of New Zealand anti-Muslim attack

Vaccination challenges for middle and low-income countries

EU: Protecting victims’ rights from cartels and market abuses

ACP-EU : Agreement on climate change, migration and post-Cotonou

Student-to-Tutor Ratio: a thought about the ideal model

State aid: Commission approves €73 million of Italian support to compensate Alitalia for further damages suffered due to coronavirus outbreak

UN chief praises impact of Palestine refugee agency as ‘our common success’, at key pledging conference

China by numbers: 10 facts to help you understand the superpower today

The ephemerality of the public-private health boundary

More Stings?

Speak your Mind Here

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s