Due to the changes in the medical device legislation in the EU, there’s a lot of things you need to know as a medical device manufacturer. That’s why we decided to start a blog post series in the past autumn, where we’ve discussed about the new MDR and its effects.
Are you ready for the new European Medical Device Regulations (MDR)? Or are you finding some answers related to the topic? If you answered yes on the second one, you’re reading now a very useful blog post as we’ve gathered here together all our MDR related blog post links with a little insights what does these posts include. You’re welcome!
PSST! If you did not found what you were looking for, please find our contact details in the end of this post for further discussion and/or questions!
This was the first writing in this MDR related blog post series, and it discussed shortly about WHYs, WHATs and WHENs, like
- WHY new MDR?
- WHAT has actually changed?
- WHAT you need to know?
- To WHOM it brings more responsibility?
- WHAT is the timing?
- HOW to proceed?
Because the recent updates to EU medical device regulations, the new MDR will have a significant impact on every medical device manufacturer’s quality management processes. Thus, we wanted to discuss and share some tips on how to proceed in implementing the new MDR to your Quality Management System. In this blog post we shared 5 most important tips that you should take into account when implementing the new MDR to your QMS.
Next, it was time to discuss about how to ensure that your existing products are compliant with the new regulation. This is important because there is no “grandfathering” - the new MDR requires existing medical devices to undergo conformity assessment to the MDR and to be CE marked anew, even if they have been on the market previously under the MDD/AIMDD. Therefore, in this blog post we shared 9 practical tips to get ready for the new MDR with your existing legacy product to ensure it’s compliant with the new regulation.
The next step was to share some tips on how to get ready for the new MDR with your new legacy product. This is also important because medical device manufacturers can place their medical products on the EU market only if they meet all the applicable requirements, meaning new MDR after transition period. The new MDR requires both existing but also new medical devices to undergo conformity assessment to the new MDR and to be CE marked. The objectives of the conformity assessment is to demonstrate that a product being placed on the market complies with all legislative requirements.
Thus, if you are developing a new medical device, you may want to start to apply the new Regulations early enough so that you are ready for conformity assessment according to new Regulations when the device design is ready. Therefore, we gathered together some tips to get ready for the new MDR with your new legacy product to ensure it’s compliant with the new regulation.
The new MDR brings some changes also in the medical device software classification, as the new MDR has implemented a new classification rule for software that must be considered when applying the definition to general medical devices. This means that most software as a medical device (SaMD) will be up-classified as Class II medical device in the new Medical Device Regulation (EU) 2017/745 in Europe. Earlier, most of the medical device software was classified into Class I in Medical Device Directive and in IVD directive.
This means that a valid CE-Mark Certificate issued by a Notified Body must be in place at latest in 26th May 2020. Additionally, you should also have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.
We wrote and shared this blog post to help you to get started with all this.
We also wrote an unofficial guidance which is intended to assist medical device OEMs by sharing some tips on how to prepare to the new European Medical Device Regulations, meaning MDR. In this blog post, we gathered together and discussed about some FAQs, answers and tips on how to get your company prepared efficiently.
PSST! Did you found this useful? Or did not found what you were looking for? Please contact our Head of QA&RA, Tiina Kotipalo, she will be happy to assist you! -- firstname.lastname@example.org