14 October was World Standards Day! It celebrates the day in 1946 when delegates from 25 countries first gathered in London and decided to establish ISO, an international organization focused on facilitating standardization. World Standards Day is the right moment for COCIR to launch our new blog offering regular insights into European and international standardisation developments!
COCIR supports the secretariat of IEC Technical Committee 62 and two of its four subcommittees: 62B and 62C. The first meeting of IEC/TC 62 took place in May 1968 in Baden-Baden, Germany; the scope adopted at that meeting, “Electrical equipment used in medical practice” is still the scope today! In fact, we celebrated the 50th anniversary of IEC/TC 62 in London, last April.
COCIR also is a liaison partner for ISO/TC 215 “Health Informatics”. This Committee has many projects in common with IEC/TC 62. And COCIR is actively involved in promoting the use of standards at international level, for example in the International Medical Device Regulators Forum (IMDRF).
Besides these international affiliations, COCIR also participates actively at the European level, including in the Advisory Board for Healthcare Standards, CENELEC/TC 62, the SMARRT Roundtable, and several actions in the framework of the Joint Initiative on Standardisation. Regular exchanges with the European Commission, Member States, CEN and CENELEC, and other stakeholders are critical to continue to emphasize the important role of standardisation for safety of medical devices, in support of the European single market, and to facilitate international trade.
Unfortunately, not everything is perfect when it comes to standards for medical technology these days, especially in Europe! Harmonisation of standards for the Medical Device Legislation is causing serious concerns. It has become clear that not all necessary Harmonised Standards will be available by the MDR’s Date of Application. We are waiting for the adoption of a standardisation request that can react dynamically to changes in the standardisation environment. COCIR will continue active discussions with regulators at national, European and international levels to ensure that industry will continue to use those important tools to show compliance to the Regulations!
What can you expect from the COCIR standards blog?
For COCIR members only: dynamic information and exclusive analysis of relevant ISO/IEC developments, including a monthly update on the activities of IEC/TC 62 and all its subcommittees.
For the general public: insights into relevant standardisation activities, how standards can support regulation, and COCIR contributions on standardisation policy in the European Union and beyond.
Technical & Regulatory Affairs Manager