Dive Brief:

• Germany's DQS Medizinprodukte has become the 16th notified body to be designated under the incoming Medical Device Regulation.

• The designation, which the European Commission disclosed Saturday, clears the specialist German medical device notified body to review products for certification under the MDR that is due to come into force next year.

• Publication of details of the new MDR notified body came around the same time as updated guidance on the use of reports from the Medical Device Single Audit Program (MDSAP), a program that allows companies to show compliance in Australia, Brazil, Canada, Japan and the U.S.

Dive Insight:

The availability of notified bodies designated under MDR has remained a worry despite the decision to delay implementation of the regulation until next year. Travel restrictions imposed to curb the spread of COVID-19 stopped notified bodies from performing on-site audits of device manufacturers, leading MedTech Europe to call for authorities to permit remote assessments for incoming regulations.

DQS has been taking advantage of the option to perform remote audits under the existing Medical Device Directive. The remote audits enabled the notified body to maintain device certifications while the German government had travel warnings in place.

On June 15, the government lifted travel warnings within Europe. DQS responded to the change by reinstating its on-site audit program from the start of last month. The notified body said it is obliged by regulations to perform audits on site and therefore cannot take internal company restrictions into account.

The resumption of on-site audits by DQS and subsequent designation under MDR clears the notified body to contribute to efforts to execute all the tasks that need to be completed by the date of application of the regulations. While European authorities have granted the industry another year to prepare, that time is only useful if notified bodies can perform their duties. 

DQS is the 16th MDR-designated notified body, and sixth from Germany, which has the largest share of any single country. With the European Commission designating four notified bodies under the In Vitro Diagnostic Regulation, authorities have now hit the target of 20 designations that they once aimed to achieve by the start of 2020.

The designation process has advanced in parallel with efforts to establish guidance to support MDR. In a recent update, the Medical Device Coordination Group (MDCG) explained how notified bodies can make use of work performed through the MDSAP.

MDSAP auditing organizations assess the quality management systems (QMS) of device companies to show compliance in Australia, Brazil, Canada, Japan and the U.S. That gives MDSAP organizations a narrower focus than notified bodies designated under MDR and IVDR, which also need to assess the safety and performance of devices, but MDCG sees value in the reports they generate.

EU law mandates annual surveillance audits, so MDSAP reports cannot replace notified body QMS assessments. However, MDSAP reports “could define in a more precise manner the activities to be performed during a surveillance audit,” MDCG wrote. As an example, MDCG cites the use of a positive MDSAP QMS conformity appraisal to justify a reduction in focus on some areas, enabling the notified body to pay more attention to MDR/IVDR requirements not covered in the MDSAP report.