The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued a position paper on Tuesday to facilitate the harmonization of medical device standards.
COCIR’s position paper set forth six recommendations on harmonizing device standards, citing an array of existing challenges such as the assessment process and the fixed publication schedule.
Harmonized standards need revision to reflect changes to and increased regulatory requirements under the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). Under the regulations, the European Commission (EC) will issue official standardization requests to align standards.
“The system for harmonized standards for the medical devices sector has not received proper maintenance anymore” and “needs to be put back on track,” COCIR said. MDR’s forthcoming application in May 2020 is “a good occasion for that” because the regulation “identifies the use of harmonized standards as [the] preferred mechanism to demonstrate conformity with the regulatory requirements.”
MDR and IVDR are expected to place greater emphasis on the important role of standardization in the field, with references to harmonized standards included in multiple places throughout both pieces of legislation.
The EC must define what harmonized standards to revise and then review each revised standard against the new general safety and performance requirements prior to the applicability of MDR and IVDR on 26 May 2020 and 26 May 2022, respectively. The EC has been coordinating with the European Standardization Organizations (ESOs), including the technical committees of the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), to avoid any potential delays…