Are you aware of all changes from MDD to MDR and how they will affect your organization?
The Medical Device Regulation (MDR) has now entered into force and will apply from May 2021. Since this is a regulation and not a directive it will be part of the local regulation in all member states.
The transition to MDR will be challenging for all involved. It demands comprehensive work by industry, Notified Bodies (NB), and the European Commission. In addition to the regulation, the commission and the Medical Device Coordination Group (MDCG) will establish new guidelines in order to help industry interpret the regulation. Also, the Notified Bodies that have decided to be operative under the regulation need to apply for designation. (Read more about the designation process and other changing elements further down.)
At the time of writing, the date for implementation is a little more than a year away. If you haven’t started your transition yet, this should now be your highest priority!
There are 2 available strategies to ensure compliance with MDR in time.
- Stand first in line for MDR application with your Notified Body.
- Last-minute renewal of your CE Mark in compliance with MDD. This is a possible route to take in order to win you some time. However, make sure that your transition process is in motion! Also note that application windows for MDD recertifications are about to close. Some NBs have set a final date at the end of Q1, 2019.
Below is a list of the top changes that will apply from May 2020.*
MDR implies increased responsibility for all actors in the product’s lifecycle
- Manufacturers will need at least one person within their organization with the title Person Responsible for Regulatory Activities. The person in this position should have correct training and medical device expertise. They will be responsible for several regulatory activities.
- There is increased focus on economic operators. For example, as a distributor you cannot pass on all responsibilities to the legal manufacturer. Distributors have the responsibility to verify that the products released onto the market fulfil the MDR requirements implemented by the manufacturer, and also that importers are following the requirements.
- The electronic database Eudamed will include several electronic systems to cover registration of devices, Unique Device Identification (UDI), economic operators, Notified Bodies and certificates, clinical investigations, vigilance and market surveillance. The database will operate as a “communicator” between Member States, Notified Bodies and the public.
Does your organization need support?
No matter where you are in your MDR journey, PlantVision can help you to take the steps needed to secure your continued license to operate in the European marketplace.
We offer a range of flexible MDR support services, which can be customized to meet your company’s specific needs:
– Gap analysis workshops
– Transition plans from MDD to MDR
– RA support during transition process (QA/RA Partner service)
– MDR courses and customized training
Notified Bodies require accreditation from member states in order to certify that products are in line with the regulation. According to the Notified Bodies Coordination Group (NBCG), Notified Bodies should apply for designation 18 months in advance of their planned accreditation. In the application, the Notified Body shall include a list of codes (Notified Bodies designation codes), which defines the scope of designation for that Notified Body and what type of products they will be accredited for.
The designation process is challenging, and if the Notified Body does not have the correct expertise covering the designation codes applied for, manufacturers for these products might need to change Notified Body. Therefore, it is important that you stay up to date regarding the decisions taken by your Notified Body. On January 21, 2019, the first Notified Body received designation for MDR. This was BSI’s UK Notified Body. Their scope of designation is listed on NANDO.
The regulation is designed to establish high levels of product safety & performance
- There are 5 additional classification rules to consider when classifying a medical device, in addition to a few changes and clarifications to existing rules. The changes may result in your products being subject to a higher risk class, which means you may face new challenges and requirements. One of the newly introduced rules is dedicated to software. This rule will change the current risk class of many stand-alone software medical devices. Software medical devices of Class I may become Class IIa or higher under the regulation.
- Some new products will now be regulated under MDR. The regulation will apply to products without an intended medical purpose (listed in Annex XVI), e.g. color contact lenses.
- Unique Device Identification (UDI) will be required for all medical devices. The tracker shall be included in the packaging and other documents included in the technical documentation. For example, the manufacturer shall keep an up-to-date list of all UDIs that it has assigned, and the Basic UDI-DI shall appear on the EU Declaration of Conformity. The UDI should also be used when reporting serious incidents and field safety corrective actions. The Medical Device Coordination Group (MDCG) has released three guidance documents concerning UDI and related issues.
- Clinical safety and vigilance requirements are increased and the manufacturer will be required to proactively collect and evaluate clinical data. A clinical evaluation together with a post-market clinical follow-up (PMCF) will be required for all risk classes. Technical documentation also needs to be updated throughout the product’s life cycle, including vigilance reports, post-market surveillance reports, and periodic safety update reports (PSUR). Manufacturers of Class III devices and implants are required to provide a Summary of Safety and Clinical Performance, which is to be made available to the public.
* The MDR transition deadline date may differ depending on the risk class of your device, the date your current MDD certificate expires, or the date for finalizing, such as databases included in Eudamed.
Arrange a free TWO HOUR seminar & workshop with our MDR specialists. We will visit your company and introduce you and your colleagues to the changes ahead. During the workshop we will help you to identify the specific challenges your organization faces as it transitions to MDR.