The Medical Device Coordination Group (MDCG) this week urged manufacturers to make sure they’re in “timely compliance” with the EU’s MDR and IVDR regulations to help stave off product shortages.
In a position paper released on Aug. 30, “Transition to the MDR and IVDR: Notified body capacity and availability of medical devices and IVDs,” the MDCG put forward a 19-point plan aimed at making sure products can be certified to the new regs within prescribed transition time frames. The document also includes recommendations for boosting the work output of notified bodies.
“Significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical devices and in vitro diagnostic medical devices to be certified in accordance with the MDR and the IVDR within the transition periods provided for in the regulations,” the MDCG wrote.
To that end, manufacturers are being asked not to dawdle when it comes to MDR compliance efforts. The MDCG is also pushing makers of IVDs to comply with the IVDR as soon as they can and not wait until the last minute to make the change.
Further, the paper calls on “all parties involved,” including notified bodies and industry associations, to offer webinars, workshops, targeted feedback and informative sessions to further prep manufacturers during this time of transition.
“Structured dialogues” are being urged between notified bodies and manufacturers both before and during conformity assessments to enhance the “efficiency and predictability” of that process. But the MDCG warns: “Such dialogues should not be considered consultancy service.”
In its paper the MDCG asks notified bodies to increase their use of hybrid remote/onsite audits, when possible, to quicken the compliance process. The group also recommends that notified bodies leverage previous audits performed under the former MDD and IVDD regs to avoid duplicating work when conducting MDR and IVDR audits.
“Moreover, the MDCG calls on notified bodies to develop schemes in order to allocate capacity for SME manufacturers and first-time applicants” for conformity assessments, the document says.
With so much at stake with the rollout of the new regulations in the EU, your company shouldn’t wing it when it comes to MDR/IVDR compliance. MEDIcept is your go-to source for comprehensive medical device regulatory solutions. We have a long history of success in helping clients achieve and maintain compliance with global regulations. Contact us today and let our roster of experts minimize your compliance risk during this time of transition.
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For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.