EU Postpones MDR Adoption Requirement for Some Self-Certified Devices and Bill to Repeal Medical Device Tax Goes to Vote
This change means that devices (not custom made devices) that are self-certified under the current Medical Devices Directive 93/42/EEC (MDD) will not have to be MDR certified from the Date of Application of the MDR (May 26th, 2020). They can rely on the Declaration of Conformity drawn up under the MDD until May 25th 2024. This will impact many self-certified devices: Class I reusable surgical devices; Software, most of which would be up-classified to Class IIa or higher; Many self-certified substance-based devices, of which some would be up-classified as far as Class III; And many others.
However, most MDR requirements will apply; this delay in certification is not a delay in application of the MDR. Therefore manufacturers must still set up quality management systems, procedures for risk management, clinical evaluation procedures and PMS/PMCF procedures, and maintain these procedures.
Of course this extra delay can only be used if there are no significant changes made in the design and the intended use of a device. The problem here is that this will not be monitored by a Notified Body, whereas such monitoring will occur for devices that rely on MDD certificates. It will be up to the Competent Authorities to oversee these design and intended use change issues. It is not clear if and how Competent Authorities plan to monitor this situation. (RAPS 12/17/19)
FDA has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019. (Emergo 12/9/19)
FDA has proposed revisions to its medical device regulations to end its practice of publishing quarterly lists of its approval or denial decisions for premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register. The proposed rule would also revise regulations for requesting copies of current PMA approvals, denials and SSEDs to direct requests to the agency’s Freedom of Information staff rather than the Division of Dockets Management. (RAPS 12/16/19)
International Organization for Standardization (ISO) has unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and additions from the previous version. The revised standard, known as ISO 14971:2019, replaces the second edition from 2007 and introduces several new definitions on the terms “benefit,” “reasonably foreseeable misuse” and “state of the art.” (RAPS 12/17/19)
The most clicked stories of 2019 on the mHealth Intelligence website were related to remote patient monitoring. This trend is reinforced by survey results which showed that 88 percent of providers indicated that they had either invested or considered investing in remote patient monitoring technology. Additional confirmation of this trend can be seen in Humana’s partnership with Philips Health to monitor Medicare Advantage patients with congestive heart failure. The most important move toward implementation came in the form of new reimbursement code development by the AMA (American Medical Association) to enable reimbursement for clinicians to provide remote patient monitoring. (mHealth Intelligence 12/2019)
The Ensuring Patient Access to Critical Breakthrough Products Act would require Medicare to temporarily cover all breakthrough products approved through FDA’s breakthrough pathway for three-years, during which CMS must make a permanent coverage determination. Since last Congress, FDA has granted breakthrough status to products that do not have a benefit category in Medicare, and therefore no pathway or coverage for Medicare patients. For example, software or digital products, such as Prescription Digital Therapeutics are not eligible for Medicare coverage because today there is no appropriate benefit category. (MDDI 12/9/19)
The permanent repeal of the medical device tax has been added to year-end spending bills, according to a bipartisan compromise. The bill also includes a provision supported by the durable medical equipment industry to exclude complex rehabilitative wheelchairs from the Medicare competitive bidding program; about $582 million in funding for the FDA for the remainder of FY 2020, which ends September 30; and a $2.6 billion increase in funding to the National Institutes of Health. (RAPS 12/16/19)
Ohio State University research shows that out-of-pocket payments have doubled in the last 5 years for non-emergency, out of network hospital care. This phenomenon is concerning because many health care consumers may not be aware that their providers are out of network, and may consequently be stuck with medical bills that they cannot afford to pay. The researchers suggest changes to policy and practice methods in order to clarify disclosure requirements and re-examine criteria for network adequacy. (Amplitude 12/16/2019)
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer and Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation. A story’s inclusion does not imply endorsement by Simbex.