Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Regulations

Entries feed - Comments feed

Wednesday 9 October 2019

What happened to my Drug Prescription Assistance Software?

We know that Drug Prescription Assistance Software are software as a medical device, thanks to the European Court of Justice. But how to CE mark that kind of software?

Continue reading...

Friday 26 July 2019

Guideline on Cybersecurity from ANSM French Competent Authority

The ANSM French Competent Authority published in July 2019 a draft guideline on cybersecurity for medical devices. The European medical device sector should greatly applaud this initiative. This is the first and only guideline on cybersecurity with regard to the European medical device regulations.

Continue reading...

Friday 19 July 2019

Guidance from GMED Notified Body on significant changes in the framework of article 120 of MDR

The GMED notified body has published a guide on substantial changes: named Guidance document for the interpretation of significant changes in the framework of article 120: “Transitional provisions” of Regulation (EU) 2017/745. This guide addresses changes according to the article 120 of the MDR. It's a decision tree in the same vein as FDA guidances on deciding when to submit a new 510k.

As a manufacturer, your mission, if you accept it, is to answer "No" for all your products CE marked with the MDD.
For hardware, be prepared to place your design in the freezer.
For software, be prepared to place your design in liquid nitrogen.

The guidance is on the page on white papers of GMED website.

Sunday 26 May 2019

MDR: one year left and too late for class I software

Today is the 26th of May 2019. Rings a bell? In one year exactly, your class I MD software will be living in borrowed time on the EU market.
Why?
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).

Continue reading...

Tuesday 26 March 2019

When the ANSM French Authority update their website without notice

To be software as a medical device or not to be.
That is the question.

And you rely on Competent Authorities to determine whether software is a medical device or not. For example, you have some practical examples on the ANSM website (google translate is my Friend): here is the lastest version.

And you wish you had a way to be noticed by the ANSM when the page changes. Hell no, no way.

Especially you wish you had been noticed when the ANSM change their mind on telesurveillance software: here is the previous version on archive.org if you want to compare with the latest.

Before: examples showing that communicating data, like tele follow-up is not a MD, with the invocation of expert function (found in MEDDEV 2.1/6 only for qualification of IVD, not MD) to exclude software without such function.
After: examples showing that tele surveillance is a MD (exit the expert function).

Arrgghh, This isn't Good Regulatory Practice.

Thursday 24 January 2019

Cybersecurity - Draft guidances from FDA and Health Canada

The US FDA published in October 2018 a new draft version of its guidance on the content of premarket submissions for management of cybersecurity in medical devices. Two months later, Health Canada published in December 2018 a draft guidance document on pre-market requirements for medical device cybersecurity.

Continue reading...

Friday 19 January 2018

FDA Guidance on Medical Device Accessories updated

Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.

Continue reading...

Friday 12 January 2018

Consequences of the 21st Century Cures Act - State of Play

Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.

Continue reading...

Monday 3 July 2017

Cybersecurity in medical devices - Part 4 Impact on Software Development Process

We continue this series of posts on cybersecurity with some comments on impacts of cybersecurity on the software development documentation.

Continue reading...

Saturday 6 May 2017

MDR and IVDR published

Hello, The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!
See the Official Journal of the EU.

Friday 10 February 2017

Final FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices - Final version released

This article is a follow-up of the previous article on the Draft guidance on Postmarket Management of Cybersecurity in Medical Devices.

Continue reading...

Final FDA Guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types

This article is a follow-up of the article on the Draft guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.

Continue reading...

Monday 24 October 2016

Cybersecurity in medical devices - Part 1 Regulations

We begin today a series of posts on cybersecurity in medical devices. Cybersecurity was not a subject before the advent of computerized medical devices. Now that every manufacturer wants its connected medical device, cybersecurity matters!
Let's start with the regulations.

Continue reading...

Friday 2 September 2016

EU Medical Device Regulation - Changes for software

We've seen in the previous article the revolution in the regulatory classification brought by the new rule 10a for standalone software.
Let's see now the other changes. These changes are relevant for all software: standalone, embedded, device or accessory.
They're not as big as the new rule 10a, but they will deserve a significant amount of man-hours and documentation.

Continue reading...

Friday 19 August 2016

Three new FDA guidances

The FDA released three new FDA guidances in July 2016:

  • Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,
  • The final guidance on General Wellness: Policy for Low Risk Devices.

Continue reading...

Wednesday 10 August 2016

MEDDEV 2.1/6 2016

A new version of the MEDDEV 2.1/6 was published in July 2016.

The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.

Add to that a few typos, and you have the new version of the MEDDEV:

  • "lossless compression" disappeared from the decision tree (was it intentional?) but is still present in the explanations of decision step 3,
  • Decision step 7 doesn't have any explanation.


MEDDEV for nothing ♫ and tips for free ♬.

Friday 22 July 2016

Is my software in class I, IIa, IIb or III - 2016 Revolution

The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.

Continue reading...

Wednesday 17 February 2016

Breaking news: standalone software is not an active medical device!

Warning: obsolete content. Please read: Is my software in class I, IIa, IIb or III.
Last update on 2016/07/31.

The British Standard Institute published in February 2016 a white paper titled How to prepare for and implement the upcoming MDR – Dos and don’ts. Register on BSI website to download the paper.
This white paper gives top-notch recommendations on the way to compliance with the future EU Medical Device Regulation (MDR), based on the draft version. But their interpretation of MDR classification rules on standalone software are somewhat surprising.

Continue reading...

Friday 5 February 2016

New FDA draft guidance on interoperable medical devices

The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.

Continue reading...

Friday 29 January 2016

FDA draft guidance on Postmarket Management of Cybersecurity in Medical Devices

The FDA released one week ago a new draft guidance on Postmarket Management of Cybersecurity in Medical Devices.
This guidance is the sister of the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices released in 2014. Both guidances address cybersecurity at different steps of software lifecycle: the 2014 guidance is about cybersecurity during design and development, the 2016 draft guidance is about cybersecurity during post-market surveillance.

Continue reading...

- page 1 of 3