Performing any kind of monitoring is a task assignment that almost everyone struggle with. We all know that it is extremely important to stay up to date with changing laws and regulations. You want to keep up with standards, common specifications, and news, and to monitor competitor products and your own products. But it’s not only important for compliance reasons. Design and development, and business decision making in general can greatly benefit from regulatory intelligence.
Challenge is that most organizations are trying to manually perform this research. It is time to stop that and start automating the work. Why? We give you 3 obvious reasons.
1. The risk of doing the job twice
When you do manual research in a team or organization, it is a struggle to avoid overlapping. It happens all the time that you and your colleagues do the exact same searches with the same keywords on the same sources. And the findings? Yes, they will probably also be the same.
Double job = twice as much time spent.
2. Handling of irrelevant content
Searching on Google and other search services will give you thousands and thousands of results. Results will easily be very broad and most of the content will not be relevant to you. Handling irrelevant content if not the most fun and effective task to do, and you certainly want to spend that time on other, more important tasks. There is also not only one place to search within, as there are lots of sources, such as databases, forums, media news and social media to keep track of. It quickly becomes a large task with so many different sources and articles to handle.
3. Missing out on important insights and updates
The effect of handling a lot of data and content is that you can easily miss out on important insights, news, updates and mentions. That’s just the human factor, but it can be solved easily by automating the process of content monitoring. By doing that, you will be able to see the results of your searches directly (same day as it is published) and can take necessary actions in a timely manner. Missing updates and mentions of your products or company can have consequences and should be prevented. The types of content that need to be taken care of right away can be incident reports, negative feedback and complaints about your products.
Let’s leave manual research in the past
So why stay in the past? Spend your time more wisely.
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What is Person Responsible for Regulatory Compliance PRRC ?
PRRC stands for Person Responsible for Regulatory Compliance. It is one of the requirements of the European Union’s Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). It intends to ensure that your company has a qualified regulatory expert at your disposal.
With this, European regulator aim to ensure you have a EU regulatory expert allocated to make sure that your company is meeting certain specific EU requirements.
What in the world is an EU Authorised Representative?
The basic principle of the EU product legislation is that no matter of the origin of the product, it needs to comply with EU legislation.
In medical device sector it means products must comply to the EU Medical Device Regulation.
In general, the Authorities in EU have the obligation to oversee this compliance when products are imported to EU.
In medical device sector, part of these Authority duties has however been given to an actor called EU Authorised Representative.
In practice, EU Authorized Representative performs some of the required compliance checks, and acts as a link between EU Authorities and non-EU medical device manufacturers.
We have sales office in the EU, do we need an EU Authorized Representative?
Simply put, every medical device manufacturer located outside of the EU are obliged to have an EU Authorized Representative
Even if you have an office within the EU, you need to designate EU Authorized Representative fulfilling the conditions set in EU MDR 2017/745.
What does the EU Authorized Representative do?
There are quite a few tasks that EU Authorized Representative is obliged to perform.
These tasks include verification that the EU Declaration of Conformity and Technical Documentation have been drawn up, checking that a conformity assessment procedure has been carried out for higher risk class devices. They are also the gate keepers in EUDAMED, being responsible for verifying that the non-EU manufacturer has complied with the EU registration obligations.
On top of these EU Authorized Representative is responsible for the Competent Authority correspondence for providing them with all the information and documentation necessary to demonstrate the conformity of a device. This is to be done in a language determined by the Member State concerned.
Additionally, EU Authorized Representative forwards to the manufacturer any request by a Competent Authority for samples, or access to a device and verifies that the Competent Authority receives the samples or is given access to the device.
In addition, EU Authorized Representative shall cooperate with the Competent Authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices, and in informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents
Last, it is to be noted that the EU Authorized Representative is legally liable for defective devices on the same basis as, and jointly with, the manufacturer.
Are small companies or low risk class devices exempted from designating EU Authorized Representative?
We are a very small company, and our device is low risk, do we still need an EU Authorized Representative?
Yes, you do. It is the law. Requirement to have a designated EU Authorized Representative is regardless of the company size or the product class.
If you are a medical device manufacturer located outside of the EU, and you want to place your device on the EU market, you must have an EU Authorized Representative. There is no relief for micro or small enterprises.
It also does not matter if your product is of Class I, Class Im, Class Is, Class IIa, Class IIb or Class III, you need an EU Authorized Representative as a non-EU manufacturer if you want to place your device on the EU market.