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.
CEN/CENELEC received the EC’s draft list of almost 200 standards in the Official Journal of the European Union (OJEU) that are under consideration for inclusion in a standardization request. With the EC’s remaining backlog of references to harmonized standards in the OJEU, the early availability of harmonized standards cited under MDR/IVDR adds to industry concerns. CEN/CENELEC medical equipment standards are developed in collaboration with MedTech Europe, the European Diagnostic Manufacturers Association and COCIR.
“The draft that has been shared recently does not meet industry needs,” COCIR said. “It refers to a list limited to certain standards with defined publication dates, which disregards the wide variety of medical devices in the scope of the MDR and will block the harmonization of standards needed for innovative technologies as well as not yet published newer editions of existing standards reflecting the evolving state-of-the-art.” It is “unclear if any harmonized standard” will be referenced in the OJEU on time.
Out of COCIR’s six recommendations, the first two relate to standardization requests. The first calls for fast-tracking the approval process of a standardization request for MDR, noting “none of the subsequent steps can be performed” in lieu of these mandates. A request should be flexible enough to accommodate both already listed revised standards as well as unlisted initial editions of standards, the second recommendation reads.
The third recommendation cites the legal obligation of publishing harmonized standards in a timely fashion in arguing for flexibility in the OJEU publication schedule, while the fourth points to the need for streamlining the assessment process as “the main bottleneck for harmonization of standards” in the medical technology sector. The final two seek EU regulators’ active participation in standard development and a mechanism to ensure the most recent standards’ editions are the ones considered.
COCIR concluded that it “expects that its recommendations are taken up in the forthcoming European Commission guidance document on practical aspects of implementing the standardization request.”
Its latest position paper follows on the heels of the one it posted
last month, offering a set of seven new recommendations to guide a strategy for regulatory harmonization of medical device cybersecurity.
Standards also came under the spotlight during the recent meeting of the International Medical Device Regulators Forum where the standards working group proposed
a new work item to establish a standard development organization liaison program.
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe