Since Covid-19 delayed the introduction of EU-MDR and EU-IVDR until 2021, many companies have been granted an unexpected reprieve from adhering to the changes to the Medical Device Directive (MDD). This extra time should enable many firms to more adequately prepare and rollout these changes in a more orderly fashion.
MDR may also finally compel device manufacturers to eschew their paper or MS Office based processes due to the necessary documentation needed to adhere.
The actual changes in regulations are not as drastic as first appearances may lead one to think, but they are more encompassing. At 174 pages for MDR and 157 for IVDR, the new regulatory documents are physically 3 times longer than the 60-page predecessor, MDD or the very thin 37 pages for IVDD, and have many more annexes than the former regulations.
That said, is it really such a huge difference for many companies?
Yes, yes, a thousand times yes!
For many companies the answer is simply “yes”. Many more medical devices will fall under the new regulations and necessary documentation required by MDR. For many midsized and smaller companies, this can be problematic. Larger device manufacturers have the infrastructure already in place to handle the additional QA/RA efforts needed. For those who were able to avoid regulatory control, MDR/IVDR will be a huge change and challenge.
Bigger and broader
The definition of “medical device” will now include many previously non-medical and cosmetic device. Devices used for sterilizing, disinfecting, and cleaning of devices – including epilation lasers and contact lenses, for example – will now be labeled as medical devices.
If that isn’t enough, many medical devices will move to a higher risk class and there will be a new classification for reusable surgical devices. IVD’s in particular will have a large increase in oversight and there will now be 4 risk classes and those will cover around 90% of those devices.
Previously only 10% were covered by risk classifications whereas with IVDR, the definition of an IVD has been expanded to include software and companion diagnostics.
Going forward, even laboratory devices, cleaning & sterilizing devices and instruments are covered by Class A, with Classes C &D handling life-threatening devices, with D being the highest risk classification. Class B will now be the “default group” covering lower risk devices such as cholesterol, pregnancy, fertility and other urine-based testing.
Safety, safety and more safety
There is also a much larger focus on “safety” – the word appears 290 times in MDR while it was only mentioned 40 times it the former MDD. To prove safety and performance claims, device manufacturers will have to create and maintain more in-depth clinical data than previously expected.
There will be a centralized EU portal that device manufacturers will be required to use when reporting their incidents, injuries and deaths. This will provide a bit more transparency in regards to safety related information for patients as they will now have access to this data for a longer time frame.
Not only initial risk is covered but also continuous, life span of the device risk has to be measured. In addition to increased focus on risk, the clinical effectiveness of the device must be documented.
Wider QMS coverage
What all of this means is that almost every medical device company will require a quality management system (QMS). And not just a QMS that complies to ISO 13485:2016, but one that includes post market surveillance for each device. The goal of this is to assist manufacturers in better understanding their device throughout its entire life cycle. What is also very import is that no products will be “grandfathered” which means you cannot simply reuse your CE info to get this done.
All devices – even those currently on the market – must conform the new IDVR standards. As a result, most companies’ Technical File (now called your Technical Documentation) will increase in size. As per EU regulators, your clinical evaluation (CE) Technical Documentation will include all technical information demonstrating how performance and safety are verified and validated by your risk assessment, manufacturing, PMS, design controls, etc.
Device manufacturers must also describe how to handle and document changes to the Technical Documentation in a formal procedure. There is no longer a distinction between a Technical File and a Design Dossier.
In the EU MDR Annex 1 replaces “Essential Requirements” with the now named “General Safety and Performance Requirements.” On the surface the requirements are quite similar, but they now also include requirements for active implantable devices, and bring forth the use of a benefit-risk-ratio.
Bigger documentation demands better tools
All of this additional information and documentation will create an all-encompassing technical library of your device. This means many companies should strongly consider abandoning the “paper / MS Office” and e-mail based processes in favor of software tools “built for purpose”.
Such artifact-based systems are better able to support the transparency, traceability and control needed to meet the new requirements of MDR/IVDR. Having the ability to link the additional safety analysis that is required to requirements, specifications, mitigations, verifications and validations in a very transparent and efficient manner will benefit both the device manufacturer and auditors.
Being able to find inconsistencies prior to an audit should always be your goal as this will save you time and money. If the change to the regulations due to MDR/IVDR is going to be smooth sailing for your company, you will need to be as confident as possible in your Technical Documentation.
By adopting an artifact based system that adheres to your process, the learning curve and other barriers to entry are lowered or completely eliminated. With software tools you can decrease costs, speed up development, lower testing time, decrease risks and have complete faith in the Technical Documentation you are producing.
Utilize the need to adopt MDR/IVDR as an opportunity to effect changes that modernize your processes.
This will enable you to start to work smarter instead of harder.