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In order to access the Brazilian market, medical devices have to be notified or registered with ANVISA, depending on their risk class. With RDC No. 423/2020, the Brazilian regulator has recently eliminated the Cadastro pathway for the registration of Class II medical devices and IVDs. This was a considerable reduction of the registration requirements for the manufacturers of these devices. The process of registration in Brazil can be very burdensome because certain products are subject to additional certification requirements, depending on their characteristics. Most electro-medical devices, independent of their risk class, have to be certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO). Following the trend towards simplifying some regulatory hurdles in Brazil, Ordinance No. 384/2020 has introduced significant changes for manufacturers of devices that require INMETRO certification and will reduce the effort to obtain and maintain this certification.

The new ordinance was published on 18 December 2020 and took effect 10 days later. It included a transition period for certificates issued under previous ordinances. Existing certificates issued under Ordinance No. 54/2016 will have to be reviewed and revised, based on the new ordinance, during the next maintenance audit, once the transition period of six months has passed. Existing certificates issued under the repealed Ordinance No. 350/2010 (and issued before 30 April 2018) may be audited and renewed until the certificate expires.

Depending on when your INMETRO certificate was issued and based on the specific ordinance, the next maintenance audit will already use the new, eased requirements. Ordinance No. 384/2020 has introduced the following changes to the INMETRO certification process:

  • On-site inspections: The new ordinance changes the requirement for on-site inspections, which will no longer be required for all certification procedures. Whether an on-site audit will be required will be based on previous audits, including under MDSAP or ISO 13485. Should the auditing entity decide that an on-site audit is unnecessary, the certification will be based on a desktop audit.
  • Test reports: The new ordinance changes how recent test reports must be: for small and medium-sized equipment, test reports may be older than two years, while for large equipment, test reports may be older than four years. Test reports must reflect the current version of the device to be certified/under review. Changes to the device lead to new testing unless the manufacturer can provide a rationale as to why changes to the device do not justify further testing.
  • Duration of validity: The new ordinance changes the expiration of certificates, since they no longer expire. Maintenance audits have to be performed regularly (every 15 months or annually).

The changes reduce the burden on medical device manufacturers, particularly regarding the requirements for the actuality of test reports. To avoid unnecessary testing, we recommend checking the current certificates and using the applicable transition period to plan and adapt your renewal processes.


ec logoToday, the EU Commission has published a notice in the OJ that notified bodies might temporarily perform QMS audits remotely in exceptional cases and on a case-by-case basis. Notified bodies can thus deviate from the IVDR and MDR requirement that QMS audits take place on-site.

Member States, notified bodies, industry and other stakeholders have insisted that travel and quarantine restrictions have significantly affected the ability of notified bodies to carry out-site audits at manufacturers' sites. As the inability of notified bodies to carry out on-site audits may increase the risk of a shortage of vital devices, the European Commission responds to requests for exceptional temporary measures, such as remote audits.

The European Commission allows these temporary extraordinary measures given the exceptional and unforeseen circumstances caused by the COVID-19 crisis, the need to ensure continuous access to safe and effective medical devices and medical in vitro diagnostics and the fact that remote audits performed under the Directives seem to show an adequate level of safety.

While reminding the Member States of their obligations to monitor notified bodies established in their territory, this notice gives them the possibility to allow notified bodies to carry out remote audits on a temporary basis. Notified bodies are required to identify and justify remote audits on a case-by-case basis, and the individual circumstances should be documented and duly substantiated. Member States are invited to inform the EU Commission of measures taken by individual notified bodies (including information to justify such measures).

We advise you to discuss your options for a remote audit with your notified body as soon as possible and use the already available MDCG documents (MDCG 2020-4 and MDCG 2020-17) on remote audits to prepare accordingly. A remote audit requires thorough preparation; this includes:

  • Scheduling mock remote audits;
  • Testing the connection and sound quality beforehand;
  • Ensuring that all audit participants are familiar with the required hard- and software;
  • Clarifying legal aspects in advance (consider data security and privacy issues in connection with sharing of documents, recordings, use of the camera, etc.);
  • If employees participate from their home office: ensuring that the connection, infrastructure etc. are sufficient;
  • Ensuring the IT department is ready to deal with possible technical problems (e.g. connection issues).

If you have questions regarding audit preparation (remote or on-site), our team of experts is always ready to help.

20201005 Flyer ILMAC 2020

BioAlps und ISS AG, Integrated Scientific Services organisieren in Zusammenarbeit mit der Swiss Biotech Association und der Swiss Chemical Society am Donnerstag, den 8. Oktober, ein Medtech-Symposium. Es geht darum Medtech-Firmen über den CE-Kennzeichnungsprozess zu informieren, insbesondere im Bereich der neuen EU MDR, welche aufgrund von Covid-19 auf Mai 2021 verschoben wurde.

In Form eines Roundtables, werden Experten der Schweizer Industrie ihre Erfahrungen und Empfehlungen zur Bewältigung der neuen Anforderungen und Zeitvorgaben austauschen. Es werden unter anderem die Herausforderungen bezüglich der Etablierung einer Produktregistrierungsstrategie, die geschäftlichen Auswirkungen der MDR, der Mangel an qualifizierten Ressourcen und die Generierung von klinischen Daten besprochen.

Kostenlose Anmeldung und weitere allgemeine Informationen, einschließlich des Covid-Schutzkonzepts finden Sie hier.

ISS AG, Integrated Scientific Services AG, participated to the 12th Global Entrepreneurship Week. With numerous events organised in 180 countries, the Global Entrepreneurship Week sets out to celebrate entrepreneurship and innovation.

The Campus Biotech Innovation Park and Geneus celebrated this event in the heart of Geneva in the form of a Café & Croissant including a virtual tour of the premises and short videos of the companies contributing to this ecosystem. The video recorded from the ISS AG Geneva-based office is here.

How ISS AG can support innovation? Please, read our offer for the Newcomers in Medtech.

Gast-Vorlesung von Hansjörg Riedwyl zum Thema Apps & Medical Device Software, October 21, 2020 am  Center for Digital Health Interventions  der ETHZ und Uni SG.

Die Teilnahme ist kostenfrei.

Mehr Informationen und den Link zum Zoom-Meeting gibt es hier.