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 The 2.3% excise tax was originally enacted in 2013 as part of the Affordable Care Act as a way to help pay for expanded healthcare coverage, but the tax was suspended by Congress in 2016.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.
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US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published
The guidance is based on the Medical Device Regulators Forum (IMDRF) SaMD Worknig Group and according to the agency they will be used to develop more specific SaMD clinical evaluation guidance in the future.
Goals of SaMD clinical evaluation
According to the guidance, effective SaMD clinical evaluation should include three major components:
- Valid clinical association between a SaMD’s output and its targeted clinical condition
- Analytical validation showing that a SaMD correctly processes input data and generates accurate, reliable and precise output data
- Clinical validation showing that using a SaMD’s output data achieves the product’s intended purpose in terms of clinical care
Emergo, US Medical Device blog
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The European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU).
Companies are reminded to plan in advance for the situation that the United Kingdom (UK) will leave the EU on 29 March 2019 in order to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU.
The European Medicines Agency
To access this guidance please follow this link.
To find out the impact of the UK leaving the EU on your business please reach out to our experts here at Instem, reach out to us on [email protected] or call the team on +44 1244 287 900.
The EMA have released the ICH ICSR (R3) guideline and accompanying business rules.
Find these documents using the following link: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500231183
For expert help on drug safety or to view products that support your drug safety activities please reach out to us on [email protected] or call the team on +44 1244 287 900.
The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU).
This was last updated in May 2016 and will affect the following standards:
Medical Device Directive (MDD)
Active Implantable Devices Directive (AIMDD)
In Vitro Diagnostic Devices Directive (IVDD)
The harmonisation process of these standards was stalled in May 2016 but it appears it has been revamped up. We speculate this is due to the UK not adopting the EU MDR and IVDR in favour of keeping the current standard.
Changes medical device companies should be aware of are:
- EN 980:2008 pertaining to symbols used in medical device labels no longer applies
- EN ISO 15223-1:2016 replaces EN 980:2008 beginning January 1, 2018
- EN ISO 11137:2015 for sterilization of healthcare products beginning January 1, 2018 (IVDD only)
For further information, the chance to talk to our experts or view our products which support medical device companies please reach out to us on [email protected] or call the team on +44 1244 287 900.
EMA to move from London, UK to Amsterdam, The Netherlands
Following the news of BREXIT where the UK announced it was leaving the European Union the headquarters of the European Medicines agency has to find a new location. There were 19 offers from member states to host the EMA with Amsterdam chosen as the final choice.
Amsterdam ticks many of our boxes,” he continued. “It offers excellent connectivity and a building that can be shaped according to our needs. I am very grateful that the Member States took into account our requirements for business continuity and gave priority to the protection of public and animal health.
Our internal surveys have shown that a large majority of EMA staff would be willing to move with the Agency to Amsterdam. However even in this case, our activities will be impacted and we need to plan for this now to avoid the creation of gaps in knowledge and expertise.
said EMA Executive Director Guido Rasi
The relocation will have to be complete by March 2019, in early December, the Agency will make available a monitoring chart on its website that will allow to track the progress made.