On this 12th European Patients’ Rights Day, we would like to congratulate European and international standardizers in the medical and healthcare sector, who contribute to making patients’ lives safer every day in the European Union!

The medical technology industry in Europe represents a market estimated to €110 billion employing 675,000 people with some 27,000 companies, of which 95% are Small and Medium-sized Enterprises (SMEs). Being one of Europe’s most innovative high-tech sectors, the medical devices sector has been growing on average by 4,6% each year over the past 8 years, according to statistics provided by CEN partner MedTech Europe (the Alliance of European medical technology industry associations).

“To be treated with safe Medical Devices” is identified by the European Commission as one of the ‘10 benefits the EU brings to patients’. European and international standardization are essential to ensure a greater safety of medical devices and in vitro diagnostic medical devices in Europe. With 20 CEN and CENELEC Technical Committees (TC) dedicated to medical equipment, standardization benefits both:

• The protection of public health and patient safety by setting safety, quality and performance requirements for medical devices,
• And the European companies specialized in medical equipment by contributing to withdrawing barriers to the trade of European medical equipment within the European Single Market and globally.

The work of our Technical Committees directly supports European Union (EU) legislation, particularly the following Directives:

• Directive 93/42/EEC on Medical Devices
• Directive 90/385/EEC on Active Implantable Medical Devices
• Directive 98/79/EC on In vitro Diagnostic Medical Devices

On 25 May 2017 two new EU Regulations were adopted that will repeal the above-mentioned Directives following a transitional period before entering into force, i.e.:

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC that will enter into force in spring 2020;
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, entering into force in spring 2020.

With new technological developments, more standardization work is now related to eHealth, currently focusing on health information systems between actors and devices that handle and process health data.
Patients can count on European standardization to make sure that Standards integrate the views of all stakeholders such as SMEs, but also consumer and societal organizations. Together, we are committed to improving patients’ rights!

Read more on our work related to healthcare on our websites:

• CEN-CENELEC website
• CENELEC website

Discover the various areas standardization in active in the medical devices field and the work of our TCs:

• CEN-CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• CEN/TC 55 - Dentistry
• CLC/TC 62 - Electrical equipment in medical practice
• CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
• CEN/TC 140 - In vitro diagnostic medical devices
• CEN/TC 170 - Ophthalmic optics
• CEN/TC 204 - Sterilization of medical devices
• CEN/TC 205 - Non-active medical devices
• CEN/TC 206 - Biological and clinical evaluation of medical devices
• CEN/TC 215 - Respiratory and anaesthetic equipment
• CEN/TC 216 - Chemical disinfectants and antiseptics
• CEN/TC 239 - Rescue systems
• CEN/TC 251 -  Health informatics
• CEN/TC 258 - Clinical investigation of medical devices
• CEN/TC 285 - Non-active surgical implants
• CEN/TC 293 - Assistive products for persons with disability
• CEN/TC 316 - Medical products utilizing cells, tissues and/or their derivatives
• CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
• CEN/TC 367 - Project Committee - Breath-alcohol testers
• CEN-CLC/JTC 16 - CEN-CENELEC Joint Technical Committee on Active Implantable Medical Devices
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