Devicemakers were critical of the European Commission’s specifications for reprocessing single-use devices, with many comments raising concerns about specifications were released earlier this summer.
Some comments said the Commission lacked the legal authority to implement the requirements, and others said it should revise or delete many of the specifications.
The commission released a draft regulation that offers specifications for reprocessing single-use medical devices that appears to offer flexibility, but it received pushback from industry for being too restrictive (IDDM, Aug. 12).
The draft specifications lay down the rules for applying EU regulations 2017/745 for medical devices, allowing reprocessing of single-use devices where permitted by individual EU member states.
The Commission stressed that certain single-use devices are not suitable for reprocessing, such as those that emit radiation, incorporate drugs, or are used in invasive procedures on the central nervous system. Also excluded are implantable devices, devices with batteries that cannot be changed, or that have cutting or scraping blades that can’t be changed or sharpened before the next procedure.
Commenters were particularly vocal about Article 5, which requires manufacturers to list technical information about their devices on their websites.
The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) said that there was “no legal obligation to communicate information on the website of the manufacturer or the authorized representative.”
MedTech Europe submitted a similar comment, stressing that the manufacturers’ technical documentation is proprietary information, and the manufacturer is under no obligation to list such information.
COCIR said there is no legal obligation for a manufacturer to provide access to technical documentation, and it said the regulator’s expectations should be further specified or the provision should be deleted.
The U.S.-based Association of Medical Device Reprocessors (AMDR) had similar concerns, citing confusion among its member who believe the specifications are intended to apply to EU MDR-regulated reprocessors.
MedTech Europe said it was not clear whether the implementing regulation applies only to reprocessing of single-use devices conducted by health institutions for their own in-house use.
AMDR took issue with the list of devices that should not be reprocessed under Article 3 as being too restrictive and said the entire section should be deleted. “Devices that cannot or should not be reprocessed will not be able to demonstrate compliance with these Common Specifications and will therefore not be reprocessed,” AMDR said. The substance of these or CE marking requirements “sets a sufficient bar to prevent inappropriate devices from being reprocessed.”
MedTech Europe scolded the commission for sending out a consultation over the summer holiday and said stakeholder consultations should be better timed.
Read the comments here: www.fdanews.com/08-29-19-Feedback.pdf.