Topic Specific News Feed

We have introduced a new feature so that subscribers can now view our newsfeed filtered by topics of interest throughout the site. For example, on our sustainability and transformation plans (STP) page, you can now view all of the STP news that MAP has reported on. 

France - The Repository of Innovative Acts out of Nomenclature (RIHN)

The Repository of Innovative Acts out of Nomenclature (RIHN) programme is designed to ensure that diagnostic tests/devices which qualify are able to receive temporary reimbursement for 3 years whilst collecting real world data to support a full assessment of the diagnostic. This page on MAP France outlines the eligibility criteria and timelines for the programme as well as who is allowed to apply for reimbursement.  

Sustainability and Transformation Plans

The idea of the sustainability and transformation plans (STPs) was first announced in December 2015 as part of the NHS planning guidance. To create the plans, organisations across the country are coming together to design “place-based plans” which will ensure the sustainability of health and care services in their area. This new page under England's "Structure and Finance" section outlines the progress made so far on these STPs and their contribution to the future sustainability of the NHS. 

The Drug Tariff – Creating a Successful Application

Reimbursement of medical devices for use in primary care in England and Wales is primarily based on Part IX of the Drug Tariff, and there are a number of steps which you can take to improve the success of your application. In this section on MAP we provide additional information to help you make a successful submission for inclusion in Part IX of the Drug Tariff, including answers to commonly asked questions and links to useful databases and sources to populate your Drug Tariff application. 

England Structure and Finance

The UK healthcare structure is constantly evolving and as a result of this, understanding the various healthcare stakeholders can be a complex process. The England "Structures and Finance" page has been updated to reflect  these changes. This page now also includes a budget analysis table highlighting how much each of the devolved nations spends on healthcare and other sectors. 

MDSAP – Ready or Not?

The Medical Device Single Audit Program (MDSAP) pilot was initiated this year, promising medical device companies the potential to enter multiple markets without having to go through multiple audits of their quality management systems (QMS).

With the pilot scheme coming to an end, and plans to be fully implemented next year, manufacturers are wondering whether the program is ready. Despite a compelling value proposition for both regulators and manufacturers, MDSAP has gained underwhelming traction so far.

Manufacturer buy-ins and insufficient cost-benefit tradeoffs seem to be causes for concern, resulting in the slower uptake of the MDSAP. Other external factors such as the European Medical Device Regulations and In Vitro Diagnostic Regulations come into play as well.

More time may be necessary in order to address these issues to ensure a better integration rate of the MDSAP programme.

For more information please click here.

Information on the Upcoming Medical Devices Regulations

Please find below, a summary of the upcoming Medical Devices Regulation, in particular its implementation by policy-makers as well as parties affected by the law.

After a political agreement was reached between the Council, the EU Parliament and Commission for both Medical Devices Regulation (MDR) and in vitro diagnostics Regulation (IVDR) proposals in June, the consolidated legal texts were translated into 24 EU languages during summer, and are now being checked for legal conformity. In this context, in particular the provisions concerning the transitional periods, e.g. validity of certificates issued prior to the entry into force of the new Regulation, are reviewed. Formal adoption is expected by Q2 of 2017, and full application by 2020 for the MDR, and by 2022 for the IVDR.

To read more of this story, please click here. 

For more information on the IVDR  please click here.

2017/19 National Tariff Consultation – Objection Thresholds Not Met

NHS Improvement and NHS England concluded the 2017/19 National Tariff consultation on Tuesday 6 December. Many organisations and individuals responded to the consultation, and they would like to thank them all for their time and effort. The consultation responses are now being analysed in detail, however, it has been confirmed that the objection thresholds for the tariff have not been met.

During the consultation, feedback on tariff changes and allocations from some commissioners was also received. These are currently being addressed by NHS England in separate exercise.

To read more about this, please click here.

£10m Invested by EPSRC in Intelligent Health Technologies Research

The Engineering and Physical Sciences Research Council have announced eight new research projects which will focus on enabling people with chronic conditions to self-manage their illnesses from their own homes. Seven UK universities are involved in the project alongside more than 30 partners from industry.  The research will investigate how wearable devices like sensors, activity and heart rate monitors and other technologies can allow clinicians to collect the data they need to advise and treat patients.

To read more about this, please click here.

Subscribers may also be interested to read our telehealth section in MAP Europe.

EMA Releases Revised Guidance on the Publication of Clinical Data

The EMA has revised its guidance on the publication of clinical data. The revised version is in compliance with the EMA’s new policy on the publication of clinical data. 
To read the revised guidance, please click here.

To read the summary of changes to “External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use”, please click here.

MHRA and HTA Sign Agreement to Create a Partnership to Protect Public Health

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA) have signed a partnership agreement which aims to promote further collaboration and strengthen the commitment to working together for the benefit of patients, staff and stakeholders and to enhance regulation.

To read more about this, please click here.

2017/19 National Tariff has now been Published

NHS England Announces £101 Million of New Funding for New Care Model Vanguards

Health Service Medical Supplies (Costs) Bill Explanatory Notes Published

Sustainability and Transformation Plans Have Mixed Digital Ambitions

Government Response to the Health Committee Report on Public Health Post-2013

What will the healthcare system look like in 2030

First Hepatitis C Virus (HCV) Diagnostic to be Prequalified by WHO

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage

Entry into Force of Medical Device and In-Vitro Diagnostics Regulations Set for Late May 2017

Citizens in the EU are Living Longer, but not Always in Good Health

NHS England Announces Major Extension of National HIV Prevention Programme with Public Health England