The MedTech Europe blog

The European Commission published on 1 June its long-awaited regulation proposal on European standardization. The document consists of the proposed legislative measures which update and consolidate existing EU legislation as well as impact assessments and non-legislative measures such as a strategic vision for European Standards. There were also a number of recommendations aimed at other actors in the EU Standardization system. I am convinced that these proposals are a significant step forward in the development of standards as an essential tool in developing the EU single market.

The proposal makes it clear that standardization is an important aspect of the European 2020 Strategy for smart, sustainable and inclusive growth and that standardization is expected to have a role in issues as diverse as continuing to protect the consumer, improving accessibility for disabled and elderly people, and tackling climate change and other environmental woes. Standards can ensure that all these challenges are met as efficiently as possible.

Producing standards is not cheap: the Impact assessment indicates that the annual cost of standardization in the EU is €3 billion and that the average cost of producing a standard is €1 million. However, the cost of creating standards is minimal compared to the benefit to the EU. The benefits can be substantial with estimates showing that standards contribute up to 1% of Gross Domestic Product (GDP) in some Member States.

In my opinion, the proposals demonstrate the belief that standards can drive innovation and advance the global competitiveness of European industry. Services (of which healthcare is an example) are now seen as an area that can benefit from standardization, and, since services contribute up to 75% of EU GDP, this is an area that should see significant activity. The speed of development and the importance of the information and communication technologies (ICT) industry are also recognized. Standardization has always been problematic in this area due to the speed with which the technology develops. The proposals therefore make suggestions as to how standards for this very important sector may be realized without inhibiting innovation.

The European Commission has also taken into account the issue of representation and makes positive proposals on the participation by small and medium-sized enterprises (SMEs), consumer groups, NGOs and organisations representing “social interests” in standardization. There is also a call for European Standardization bodies to ensure appropriate representation by such bodies as research centres and universities. The objective is obviously to try and make the representation on Standards Committees as inclusive as possible.

So what does all this mean? Well… it depends. There are obvious fears in some quarters that there will be a proliferation of ‘rules and regulations’. Yet it must be remembered that standards remain voluntary. Nevertheless standards help to compete abroad and therefore they can make life easier. Consumers too have demonstrated a clear preference for products that meet standards – it gives them confidence in what they are purchasing. What is clear is that challenges will be introduced. This should not hold any fears for a regulated industry like medical devices that is well versed in using standards to ensure that manufactured devices comply with legislation and other requirements. However, SMEs, and especially medical technology SMEs, must take the opportunities being offered to get involved and make sure standards work for them. Wider representation of other interests such as consumers and social interest groups on technical committees should ensure standards meet the demands of the wider society, increasing their relevance and utility.

After the summer the proposed Regulation should be scrutinized in the European Parliament and the Council. The Parliament has already shown that they believe standardization to be very important and adopted its own initiative report towards the end of 2010. The Council review of the proposals is also expected to start during the Polish Presidency of the EU and to continue well beyond it. It is very probable that it will be led by those Member States who are already very active in the standardization area like Germany and the UK.

That the Commission and the Parliament see standardization as an extremely important vehicle to delivering the 2020 agenda is a very powerful endorsement of the standardization system. Nobody will claim that standardization is not without its niggles; nevertheless great confidence has been shown in the system’s ability contribute significantly to a smart, sustainable and inclusive Europe.

Andy Vaughan
Eucomed Consultant Environment

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  1. Dear Friends,
    I have read this interesting article

    “the proposals demonstrate the belief that standards can drive innovation and advance the global competitiveness of European industry.
    Services (of which healthcare is an example) are now seen as an area that can benefit from standardization, and, since services contribute up to 75% of EU GDP”

    I suppose that people’s health and environmental protection to protect people and our planet are the basis for all rules, regulations and standards

    Kind regards
    Anna

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