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Archive for month: November, 2017


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.


ISO IDMP brings benefits to regulators, industry and, ultimately, patients

Christian Hay, Senior Consultant Healthcare for GS1 Global Office has spoken out about revised IDMP standards. 

Mr Hays explains:

IDMP standards are essential for the world’s increasingly integrated healthcare. They provide the precise architecture for the computerization of information on medicinal products all around the world. When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records.

The ISO IDMP working groups are currently collaborating on creating the implementation guides and will cover the following aspects:

  • Medicinal product name
  • Ingredient substances
  • Pharmaceutical product (route of administration, strength)
  • Marketing authorization
  • Clinical particulars
  • Packaging
  • Manufacturing

The implementation of ISO IDMP will have a large impact on the industry and your company, Instem already supports XEVMPD through Samarind RMS and can support you as you transition into IDMP. To speak to one of 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.


EU & FDA to Share Inspection Outcomes

A major cooperation milestone has been reached between the European Commission & the US FDA.

November 2017 sees a mutual recognition agreement drafted, enabling the recognition of inspections of manufacturing sites for human medicines conducted in their respective territories. This cooperation will aim to improve the use of available resources to safeguard quality and safety of medicines.

The agreement enables both the EU authorities and the FDA to make better use of their inspection resources and focus on sites of higher risk where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured.

European Medicines Agency



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