The May 2020 deadline outline in Reg 2017/745 is a cutoff for new filings under MDD, the previous regulation. If your product is already CE Marked under MDD, you do NOT necessarily have to re-certify by the 2020 date but could keep your product on the market up until May 26th, 2024.
There are several changes in the new EU MDR as compared to current directives for medical devices. The new regulation includes below important changes:
Device Scope Management
As per MDR, the medical devices and will be significantly covered to include devices that have no medical intended purpose. For ex-colored contact lenses and contact lenses and cosmetic implant devices and materials.
Also included in the scope of the regulation are devices designed for the “prediction and prognosis” of a disease or other health issues.
Choosing The Right “Qualified Person”
At least one person within the organization will be responsible to identify that all aspects of compliance meet the requirement of new regulations.
The organization must disclose the vacancies with the specific qualifications of this individual relative to the required tasks.
Execution of UDI (Unique Device Identification)
After the proper implementation of the New MDR, it is necessary to implement the use of Unique Identification of Device mechanisms.
With the help of the UDI number, the manufacturers can trace devices through the supply chain and brief the proficient review of medical devices that have been found to present a safety risk.
Post Market Oversight
The MDR demand expanded post-market reconnaissance authority by the Notified Body. The on the spot reviews, along with item test checks and item testing, will fortify the EU’s authorization system and help to diminish hazards from unsafe devices. Yearly performance and security reporting by manufacturers will likewise be needed much of the time.
The new MDR strictly allows EU commissions or expert panels to publish the common instructions which at some level be considered by manufacturers and the notified bodies.
These common instructions do exist in parallel to the harmonized standards.
There will be a reclassification of devices based on the risk, contact duration, and invasiveness. Manufacturers need to review the new classification rules and update their technical documentation accordingly as per the new regulation.
Thorough Clinical Proof For Class III and Implantable Medical Devices
Going forward, manufacturers will conduct clinical investigations if they do not find any proof to support the claims done in terms of dedicated device safety and performance. It’s necessary for manufacturers too to collect and retain post-market clinical data as a part of the device safety.
Well-organized clinical evaluation of Class IIa and Class IIb devices
Manufacturers need to re-setup their clinical evaluation as per new guidelines of the MDR to justify the equivalence of devices and under what circumstances the justification is not required.
When Should You Certify Immediately
If your product was previously Class I self-certified, but under MDR will require Notified Body approval then you have no choice but to certify right away.
If your product has significant support from clinical evidence already then it also makes sense to certify right away.
When Should You Wait
If your product is already CE marked and no large changes are planned in the next several years; then it is perfectly reasonable to wait to re-certify until closer to the product’s expiration date.
If your product would benefit from further clinical data being gathered, then it also would make sense to wait longer before re-certifying. This is a judgment call that can be determined by a preliminary risk-benefit review. If you determine that more clinical evidence would strengthen your application, then waiting can be a wise decision.
The important thing to note is that the date of application in 2020 is NOT a hard cutoff for your existing products, but it is an important data point to consider when defining your MDR compliance strategy going forward.
Risks Of Waiting
Another thing to consider is whether or not the notified bodies will be able to keep up with the influx of filings and CE Marking requests over the next several years. While it is true that according to the regulations you may be able to delay filing past next year’s deadline, in practice it may not work as intended. There is a very real possibility that your product’s MDD certification could expire while your MDR paperwork sits in a queue waiting for Notified Body Approval.
A Hybrid Approach
Of course, there are plenty of variations in between certifying today and waiting until the deadline, and likely your organization will fall somewhere in between the two extremes depending on the amount and classifications of your product offerings.
Conformity Assessment Procedures
It will be a time-consuming and tortuous process for device manufacturers to address new regulatory requirements and obtain NB approval.
Currently approved devices are not exempt from new requirements of EU MDR and will need to be re-evaluated and re-approved.
So manufacturers need to apply for applicable conformity assessment procedures based on the product classifications.
The capacity of Notified Bodies
After the introduction of the new MDR, the NB is under pressure. Previously these stakeholders were industry partners now these are decision-makers.
NB’s play a significant role in conformity assessment procedures, in fact, their requirement is increasing day by day. So to maintain the designation, NB,s are supposed to increase their technical expertise to increase the scope of designation.
There will be a stricter requirement for high expertise and qualified staff. They are authorized to request expert panels to examine their clinical evaluation reports.
At present, there are 19NB, Under NANDO (The New Approach Notified and Designated Organisations). Who are capable of issuing conformity certificates.
Manufacturers will have to keep in mind the specialization and expertise of NB. As not all will assess for higher risk devices or not all have the experience in the same field.
The number of NB’s is likely to increase in the future. They are under a hiring process that usually takes around 18months from application to inclusion in the NANDO.