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

Author Archive for: ellas

by

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.

by

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

by

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.

by

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.

by

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: 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.

by

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.

 

Contact us for a demo now!