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The FDA’s DRAFT guidance for this can be found here.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


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].



Could the EUDAMED set the global standard?

With the implementation of UDI in the EU following the roll out of the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), the European Database for Medical Devices (EUDAMED) has been created in anticipation. It has now been suggested that this database will be extended and set the global data exchange standard. 

Currently when accessing EUDAMED European Authorities have full access to the data while those outside only have public or limited access. The European Commission is considering extending the access to boost sharing of the device safety information with the suggestion that this can set the standard for global data exchange in the industry.

This extended access will be rolled out, the European Commission is thought likely to choose those already taking part in the NCAR exchange programme. The data exchange would be an extension to the NCAR system.

This seems a very ambitious project and we imagine it will take some time to coordinate. We suspect that it will require other UDI systems to become compatible with EUDAMED and that they will be involved in its further development.

If you would like some assistance with managing your medical devices and their UDI data please reach out to our experts here at Instem. This can be done via our main contact number +44 1785 825653 or email us on [email protected].


Latest MDR & IVDR Progress

Where are we now

25th May 2016: MDR & IVDR final agreement was reached

7th March 2017: Final adoption from EU council

5th April 2017: Final adoption from EU parliment

5th May 2017: Official publication

25th May 2017: MDR & IVDR now in force

26th Nov 2017: NBs apply for designation

26th May 2020: Full application for MDR from now on

26th May 2022: Full application for IVDRfrom now on


Transition Timeline For MDR & IVDR

For assistance with your EU UDI compliance or managing your medical device data and registrations reach out to our expert team at [email protected] or +44 (0) 1244857901.


Brexit & The Medical Device Industry: Worst Case Scenario

 A new notice from the European Commission lays out how Brexit will impact economic operators including medical device companies, Authorised Representatives and Notified Bodies.

In Jan 2018 the European Commission published a notice that identified medical device companies, authorised representatives and NBs that will be affected by Brexit. Many of these impacts would be only in a “worst case” scenario for example, if no mutual recognition agreement is reached, which at this point in time is unlikely. Testing this theory are the Brussels negotiators pushing a “no deal” concept. 

Brexit and Authorised Representatives (AR)

British manufactures will need an EU based AR, manufactures placing devices onto the EU market can only do so if the firm is based in the EU or they have an EU AR. Some sources speculate the UK will be treated like a third Country.

Importers and distributors

Following this same vein the UK will therefore no longer be able to be used by third countries as importers for the EU. If the distribution network isn’t evaluated and modified UK distributors will instead be considered importers. UK NBs can’t be used for the EU and new NBs will need to be appointed for your products.

Void CE Certificates 

CE certificates for EU regulations can only be issued by Notified Bodies based within the EU. This means that all certificates issued by UK-based Notified Bodies will become void after 29 March 2019. After that date British Notified Body can no longer issue CE Certificates for the EU.

UK-based manufacturers will need an AR, just like any non-EU manufacturer. They will have to create a distribution network with an AR/importer.

Suggested Effects

Problems with distribution networks effected downstream from UK operators will be an opportunity for EU based organisations.

Smaller UK device companies may have device availability effected.

New non UK based NBs will need to be found.

Possibly those most likely hit are British patients.

They will face the prospect of manufacturers that cannot reach the UK market as easily as they do now. Any-UK based manufacturer may incur additional costs for placing devices on the European market, which will be reflected in their product prices.

Emergo, Jan 2018

If you wish to discuss how Instem can support your company through Brexit please reach out to our team with your needs, [email protected] or +1244857900.


US Medical Device Excise Tax (MDET) Returns in 2018


Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018.

After a 2 year reprieve the tax has been reintroduced with change in legislation at the end of Dec 2017. The 2.3% excise tax was originally enacted in 2013 as part of the Affordable Care Act as a way to help pay for expanded healthcare coverage, but the tax was suspended by Congress in 2016. Medical device trade associations estimate the tax could put a $20 billion damper on the industry over the next decade. The tax is thought to be enforced from early 2018. Repeal efforts have so far not succeeded.

For help and support regarding managing your medical devices reach out to our experts on [email protected] or call the team on +44 1244 287 900

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