Now part of +44 1785 825653 Email Us E-Learning

Archive for month: March, 2018

by

Combination Products: New PMSR FDA Deadline

FDA announces new compliance deadlines for the combination product post-market safety reporting (PMSR).

In order to allow combination product applicants more time to get their procedures and reporting in order the FDA have pushed the PMSR compliance deadlines to 2019 and 2020.

The PMSR rules were finalised in 2016 but the FDA have chosen to push this to July 2019 for combination products using the FAERS & eMDR reporting systems. In addition by Jan 2020 for combination applicants  using the VAERS reporting system.

The FDA’s DRAFT guidance for this can be found here.

For regulatory management and tracking of your combination products or advice from our team reach out to Instem via +44 1785 825653 or email [email protected].

by

Switzerland: MedDO to MDR

The Swiss Federal Office of Public Health (FOPH) has announced that their current medical device standard Medical Devices Ordinance (MedDO) will undergo revisions in order to reflect the EU’s adoption of the MDR and IVDR. Although Switzerland isn’t part of the European Union it bases its regulations around the EU rules in order to maintain access to the EU market.

The enforcement of the new EU MDR rules is thought to be a staged approach but ultimately tie in with the EU times lines, therefore this will come into force in Switzerland during 2020.

If you have any concerns regarding managing changing standards on a global scale the Instem team are always here to help. You can call us on +44 1785 825653 or email [email protected].

 

Contact us for a demo now!