A January 11 notice gives EU notified bodies leeway to conduct remote audits under the MDR and IVDR. That and a new notified body, are Market Pathways’ picks of the week.
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After months of urging from industry, the European Commission has granted leeway for notified bodies to conduct remote, instead of onsite, audits to fulfill requirements of the EU Medical Device and IVD Regulations in the context of COVID-19 travel restrictions. Last spring, the EU granted a one-year delay MDR application, to May 2021, but since then companies have argued they haven’t been able take full advantage of the extra time because pandemic restrictions have halted notified body progress on some MDR files, as Market Pathways reported in June. (See “MDR at a New Standstill: COVID-19 Distancing Defers Certification Audits”Market Pathways, June 22, 2020.) While the Commission issued emergency policies in April allowing remote audits to fulfill certain elements of the legacy EU Directives, those allowances did not extend to compliance to the new regulations. That was until the Commission’s January 11 notice, which gives notified bodies rope “to take temporary extraordinary measures, including remote audits” under the MDR and IVDR. The Commission makes clear in the notice that it wants this to be a limited, only when-needed flexibility. Reliance on remote audits should be limited in duration, justified on a case-by-case basis, and “not go beyond what is required to ensure continuous availability of safe and performant devices, when concrete obstacles to complete conformity assessments on-site have been created by COVID-19 circumstances,” the notice states. The Commission also requests that EU Member States keep track of notified bodies performing MDR/IVDR remote audits and the impacted device certificates.
Merlin Rietschel, a senior manager at MedTech Europe, which called for the emergency policy, said on LinkedIn that the notice is a “significant and positive development.” He also noted, “It is now of crucial importance that we avoid fragmented approaches amongst EU Member States.”
New notified body.On January 9, Helsinki-based SGS Fimko OY became the latest to be designated under the EU MDR. It is the first MDR-designee from Finland and brings the total number of MDR notified bodies back to 18. (It fell down to 17 on January 1 when BSI UK was removed from the list with the full activation of Brexit.) SGS Fimko was designated with a relatively limited scope of practice, signed off to perform assessments for about half the number of product types that the most versatile notified bodies can address, and with an array of conditions.