A number of high-profile recalls and medical device failures prompted the European (EU) medical device industry to revisit the regulatory process and improve standards.
The new EU MDR was formally published for medical device companies, with "entry into force" on May 25, 2017.
Three-year transition for companies to achieve compliance to the new regulations.
The EU MDR implementation takes full effect. All devices are required to be in compliance with the regulation by May 25, 2020. MDR certification is required unless MDD certification is still valid.
Regulation of medical devices in Europe has been remained relatively unchanged since the 1990's. However, recent crises in the medical device industry have brought to light the need for new medical device regulations. These reforms were applied in the new EU Medical Device Regulation, entered into force in 2017, with mandatory adoption for all medical device companies.
The EU medical device regulation changes were created to ensure medical device companies maintain a high standard of quality in an effort to avoid any further failures or serious recalls. Moving forward with these revisions, all medical devices will require a safety and performance audit before they can be marketed in the EU.
Medical devices will also be required to provide patients significantly greater transparency regarding the benefits and risks of the products, and will be required to complete a risk/benefit ratio assessment.
The impact of these changes will be seen throughout the entirety of a company. If compliance is not met by the outlined time, companies can face fines, recalls, import bans, or revoked licenses.
R&Q will work closely with your company to provide you with strategic and implementation tools and support to efficiently and effectively ensure EU MDR compliance.
High-level examination of all items with significant impact in the EU MDR. Up-classifications, lack of clinical evidence, own-brand labeling, QMS impact, economic operators, UDI, new testing requirements, and more…
Built based on the results of your impact assessment and includes a project charter and client-specific training program. It also includes a preliminary program plan, schedule, and budget.
Conduct gap assessment of every regulatory file (tech files and dossiers) or until consistent themes are identified to enable remediation planning. Then, gap to all elements of the MDR. There is much more to this step! Contact us.
Plans developed include a regulatory impact plan which aligns your portfolio to MDD and MDR certification timelines (and more), quality plan for managing QMS changes, and an overall program management plan and schedule.
This includes effective program management and regulatory intelligence monitoring. Other critical aspects include establishing a program governance process to efficiently resolve questions and issues in a timely fashion. KPI’s are monitored and reported up effectively on all workstreams.
2020 is not far away. Given the extensive amount of work that must happen between now and then, if you don’t start now, you won’t finish. The resources of the notified body and lead times will not be available. The closer to the 2020 date, the longer we’d expect the lead times to be...if you can even get the support. At the minimum, you must execute your plan and understand how big of a gap you have to fill between now and then. At least then you’ll know if your products are in good shape with only minor tweaks to make. Hitting that date will be impossible if the plan isn’t started today.
For Class III and implantable devices, you will need an agreement granting you full access to the competitive manufacturers technical documentation. The amount of data required will vary based on the type of device and the indications. In all cases you should consider the intended use, the technical characteristics and the biological characteristics.
The state of the art should include a summary of the clinical background for the corresponding medical field, a description of the medical alternatives available to the patient population, a summary of the applicable standards and guidance documents, and a conclusion regarding the subject device compared to the state of the art. The clinical background summary will include details on the medical condition, users, and patient populations. The description of the medical alternatives should include data on the safety and performance of benchmark/similar devices and alternative therapies as well as a summary of the advantages/disadvantages and benefits/risks of those alternatives. The state of the art should be supported by literature references identified through a systematic literature search. The amount of detail included in a state of the art is usually proportional to the complexity and risk of the device.
Although the Competent Authorities have the responsibility to monitor the Economic Operators, the overall surveillance plan is developed by the EU Commission through the MDCG and results of the surveillance that suggest a problem with a device are shared with other Competent Authorities, the EU Commission, and the NB who certified the device.
Each Notified Body is establishing their own deadlines and you will need to talk to yours to confirm your planned dates are acceptable. Our experience is that they will accept renewals in advance but are starting to cut off renewals as early as March 31, 2019 for at least one NB leaving a limited time to get those completed. There is a good FAQ guidance document that outlines the transition period and how it works. https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_MDR_180117_V1.0-1.pdf
These are reusable devices. This is a new classification and requires NB involvement, much like
This is a tough question as it will vary based on the risk class of the device and should really be discussed with your Notified body. Some manufactures use a decision tree similar to the FDA decision tree for submitting 510(k)s to determine if a change is significant or not. This doesn’t encompass everything that should be considered, but may be a good place to start.
Safe disposal testing will vary based on the type of device. Testing may include tests like validation of the cleaning or decontamination instructions for the device, verification of disposal method (i.e. can the device be incinerated?), or verification of safe disassembly instructions if device must be taken apart for disposal.
This is occurring today. If you list key suppliers and contract manufacturers in your technical documentation, then it would be incumbent on the manufacturer to have a quality agreement with the supplier letting them know that because the products are CE marked that it is part of the agreement that they agree to support such audits.
We anticipate some companies will choose to go with US launch and utilize that market experience to fulfill the clinical requirements for the EU so we are starting to see a shift in launch strategies for products that will be commercialized after May 2020.
We have heard that none will be available in 2018 and suspect that none will be available until at least mid-2019. Here is a rolling summary of pending documents from the EU Commission: https://ec.europa.eu/docsroom/documents/31902
We created our gap assessment templates utilizing the EU MDR. Depending on where your devices are being sold you would also roll in requirements from the other regions where devices are being sold (US, Canada, China, etc) and any standards you are complying with such as ISO 13485.
Under the EU MDR, in the case of “private labeling” or “own brand labeling” or “virtual manufacturing” the person placing their name on the device when placing it on the market is the manufacturer and responsible for the general obligations outlined in Article 10 of the EU MDR including having full technical documentation available.
Yes, the MDR does offer some guidance around this subject similar to the FDA. In Annex VI Section 4.10, MDR states “Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilization or refurbishing between patient uses shall be permanent and readable after each process performed…”. However, direct marking does not apply if any type of direct marking would interfere with the safety or performance of the device, or if it is not technologically feasible to directly mark the device.
The PRRC does not have to reside in the EU. You do need to have a person or persons assigned for each device or device family but it can be across several divisions. You do need to be careful that there are no conflicts of interest for the person(s) assigned. One risk that has been identified is that if you choose for example the V.P. of Regulatory and they have a compensation package that rewards them for lack of recalls/hitting launch targets that can be seen as a conflict with the duties of the role which is to make decisions about product compliance or field actions and per the regulation there can be no disincentive for taking such actions.
These apply to devices that are marketed/sold in the EU or in the case of software where the information is used in the EU (even if data processing occurs outside the EU).
We would say that there is not one best way. The MDR does have specific sections, but none identified as just applicable to manufacturing. For manufacturing, I would consider starting with requirements from Article 10 Section 9 (QMS), Annex I (GSPR) and Annex IX (Conformity Assessment). Article 10 (9) and Annex IX will cover
Yes, there is a requirement for a risk management plan that we have heard is more product specific than how it was utilized in the past