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FDA Deliver Final Guidance on the Clinical Evaluation of Software as a Medical Device (SaMD)

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

For further information or consultation with our experts reach out to us on [email protected] or call the team on +44 1244 287 900.


Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU


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.


ICSR (R3) Implementation Guidelines and Business Rules

The EMA have released the ICH ICSR (R3) guideline and accompanying business rules.

Find these documents using the following link:

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.


EU Updates for Harmonized Standards for Medical Devices and In-Vitro Diagnostic (IVD) Products

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 Headquarters to move from UK to Netherlands


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.


Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions

 US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency.

The draft guidance for covering changes to a registered device’s hardware and software that necessitates new 510(k) clearance was released in August 2016, following the release of the final guidance there are no major changes from the previous draft.

Changes that may require new 510(k) filings

  • Any hardware change intended to improve a device’s safety or effectiveness requires a new 510(k) application.
  • Changes to labelling; technology, engineering or performance; or materials may also require new premarket notification submissions.

For device software, FDA requires submission of new 510(k) applications in the following instances:

  • Change introduces a new risk or modifies an existing risk that could potentially result  in significant harm.
  • Change causes the need for a new risk control measure or modification to a current control measure to address a potentially dangerous situation that could cause significant harm
  • Change significantly affects clinical functionality or performance specifications directly tied to the device’s intended use

If you need support creating, submitting or keeping track of your 510(k)’s reach out to our experts or view a demonstration of our product please reach out to us on [email protected] or call the team on +44 1244 287 900.

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