With the entry into force of the Medical Device Regulation (EU 2017/745 MDR) on 26...
Despite delays, medical devices soon cannot be placed on the European market without adhering to a set of new, more stringent safety requirements: the Medical Devices Regulation (MDR).
The exception will be three groups of medical devices in Class I which, according to a recent EU ruling, gained an additional four years to comply with the new regulation.
The goal for MDR is to increase transparency in the medical devices production chain. The Notified Bodies (NBs), and manufacturers will be placed under a lot of pressure, especially once the new evaluation of medical device classes is implemented alongside the MDR’s introduction.
To try to help you cope with this stressful period, we gathered seven top tips when dealing with the MDR and the ways it may affect your business.
Tip #1 – Study the new MDR
We know this one seems obvious, but the first step is to read the document itself. Have you already done it?
In order to prepare for the MDR you need to read the actual document, do a detailed analysis of the changes and how they will impact you.
Tip #2 – Join the community
It is only natural to have questions after sifting through the new MDR document.
Besides looking for the help of experts, why not join discussion groups on social media? Take a look at groups like the EU Medical Devices Regulation discussion forum on LinkedIn to read more about what other businesses are experiencing and try to use this when faced with your own medical device issues.
Tip #3 – Create a plan
Now that you have all the means, design a plan including a timeline and a map of resource allocation.
Put together a list of tasks in order to evaluate what the next steps are and to define achievable goals, applying deadlines based on an order of priority. Doing this is important as, with every passing deadline successfully achieved, you’ll feel a lot more motivated to continue your hard work.
That, and the fact that sticking to deadlines in itself naturally makes us more motivated to get on and do some work…
Tip #4 – Be honest with yourself in light of your company’s strengths
Think in terms of your weaknesses but also your strengths. At this point you have (hopefully!) read the most important parts in MDR, meaning you are aware of your role and responsibilities for the next year. So, now two important questions need to be asked:
- Are you able to do it alone?
- Do you need to look for a partner to help you understand and implement some of these changes?
Tip #5 – Adapt and adjust
Not everything needs to be built from scratch and, indeed, not everything will change. Some previous regulations – IEC 62304, IEC 13485, ISO14971, among others – will still be in place, combined with the new MDR compliance infrastructure.
Tip #6 – Be aware of the consequences
Products without an appropriate quality system could be banned by the authorities. If your medical device doesn’t comply with the up-to-date rules and regulations, it could ultimately be recalled.
Being non-compliant has the potential to injure your business’s reputation elsewhere, in terms of other products and services. Be aware of this and make sure you leave no stone unturned in protecting yourself against the risk of non-compliance.
Tip #7 – Think for the future
The primary objective of the MDR is to ensure a regulatory framework which is sustainable, forceful, foreseeable and clear. The actions that you take now will see you well on your way towards a brighter future, laying the foundations for your future work in the industry. Build fundamental principles now and the future will be more sustainable.
New classification rules allied with post-market surveillance will demand more from all parties involved in medical devices, but especially from manufacturers. But the list of changes doesn’t finish there! There will be a Unique Device Identification (UDI) system to improve the identification and traceability of medical devices along the supply chain, as well as the creation of a European database (Eudamed) with all kinds of information pertaining to medical devices. Fortunately for you, we’ve summarised all the changes in our free white paper. It’s the perfect starting point to learn more about the MDR.
If you are looking for extra help ahead of the new regulation, let us know here. We’d be more than pleased to lend a hand!
At a system level, the typical development cycle starts at the system concept and finishes...
The art and science of user experience design (UxD) shapes many of the products and...
Doctors and other health professionals expect medical devices to assist them more and more during...