As part of our goal to keep our customers informed and up to date, we will now be regularly publishing a MedTech news round up.
Highlighting five timely topics across the sector, our aim is to present key information from credible sources in a quick and easy format. Read on for our November update.
Regulating medical devices post Brexit transition
The UK government has updated their guidance on regulating medical devices for the British, Northern Irish and EU markets from 1 January 2021.
With the transition period for Brexit coming to an end this year, the updated guidance advises the necessary steps to take. From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market, that are currently undertaken through the EU system.
The updated guidance provides information on how the UK system will operate regarding getting your in vitro diagnostic or active implantable medical device certified, conformity marking your device, and registering your device with the MHRA. The guidance covers the differences in rules that will apply in Great Britain (England, Wales and Scotland), Northern Ireland and the EU.
The proposals outlined in the guidance will take effect through legislative changes that will be introduced later this year, and as such, are still subject to parliamentary approval. For more information including a summary of the key requirements for placing your device on the British market, click here.
FDA shares current thinking on Biocompatibility of devices in contact with intact skin
The FDA has published draft guidance to propose select updates to the 2016 Biocompatibility guidance: “Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process”.
This draft guidance will add or supersede applicable sections of the 2016 Biocompatibility Guidance, updating the FDA`s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that come into contact with intact skin.
In order to determine the potential for an unacceptable adverse biological response resulting from contact of the materials of the device with the human body, the intention is that this guidance will assist manufacturers preparing for the following:
- Premarket approval applications (PMAs)
- Humanitarian device exemption (HDE) applications
- Investigational device exemption (IDE) applications
- Premarket notification (510(k)) submissions
- De Novo classification requests (De Novo requests)
The draft guidance covers which types of devices and materials are included and excluded, what biocompatibility information should be included in a premarket submission, and the FDA`s recommended content and format for certain labelling information related to this policy.
When final, this guidance will update Sections II and III and add a new Attachment to “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,’” issued in 2016. For more information click here.
European Commission to make Actor Registration Module available from 1 December 2020
The European Commission will make the Actor Registration Module available to Member States and economic operators from 1 December 2020.
The first of six EUDAMED modules, the Actor Registration Module enables economic operators to submit, by means of an Actor Registration Request, the information necessary to obtain a Single Registration Number (SRN). The SRN then guarantees an EU-wide unique identification for economic operators.
Every economic operator – including EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers, has to register as an actor in EUDAMED and provide the required information.
As part of the Actor Registration Request, all actors must upload a signed declaration on information security responsibilities. To register in EUDAMED, non-EU manufacturers must also have an active authorised representative, and submit a Mandate Summary Document with the registration. For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request.
From 1 December, access to the EUDAMED database and EUDAMED webpage will be active. For more information including a user guide for Economic Operators and Technical Documentation click here.
CDRH COVID-19 related workload impacts Q-submission reviews
In recent comment to NAMSA, the FDA has cited that certain CDRH offices are now significantly impacted by COVID-19 workload, which will in turn affect Q-submission reviews.
The following offices are noted as impacted:
- In Vitro Diagnostics and Radiological Health
- Surgical and Infection Control Devices
- Ophthalmic, Anaesthesia, Respiratory, ENT and Dental Devices
- Orthopaedic Devices
Pandemic-related tasks (see the FDA’s COVID-19 Response webpage for more details), have strained the agency’s resources dramatically, meaning that Q-submissions moving forward will be affected.
The offices most significantly impacted, (as noted above), are employing an algorithm to evaluate Q-Submissions as they are received, to determine if they are predicted to be closed without review or accepted. If your product is deemed important to public health, the FDA has communicated that these types of products will likely be accepted for review. Submission Issue Request (SIR) Q-Submissions will not be impacted.
If your Q-Submission is closed without review, you may submit a supplement to request that the FDA continue your Q-Submission review at a later date, as resources allow. You should be prepared for these reviews to take longer than the average 70-day review timeline, with a new expected review timeline of 120 calendar days or longer.
For more information, including the impact on other submission types, click here.
FDA shares new Cybersecurity vulnerabilities discussion paper
Last month was National Cybersecurity Awareness month. This year`s theme: Do Your Part, #BeCyberSmart, focussed on key areas including securing devices at home and at work, securing internet-connected devices in healthcare, and technological innovations.
To provide features that improve healthcare and better develop the ability of healthcare providers to treat patients, medical devices are becoming increasingly connected to the Internet, hospital networks, and other medical devices. But connected medical device solutions also increase the risk of potential cybersecurity threats – they can be vulnerable to security breaches just like computer systems, which can potentially impact the safety and effectiveness of the device.
Reducing cybersecurity risks is especially challenging because these vulnerabilities cannot be eliminated. The healthcare environment is complex, and so collaboration amongst industry stakeholders is key to help manage cybersecurity risks ongoing. Sharing knowledge and resources within the medical device community is one important way to “do our part”.
The FDA has shared a new discussion paper for review and comment. “Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework” is now available – click here to find out more.
That concludes this month`s update. Check back in December for more MedTech news.
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