Amidst the COVID19 chaos, it is important we snap out of panic (or denial, for some) in dealing with this crisis. With the current disruptions to business, we must remain resilient and focus on surviving. Despite current climate, RNI remains operational as we continue to monitor the MDR situation closely.
Attention Class I medical device manufacturers! Dooms day (also known as the date of MDR application) is soon approaching. Are you ready for the 26th of May 2020?
Even if your products have obtained a transition period until May 2024, certain MDR requirements must be included in your files for May 2020.
Class I medical devices find themselves in an interesting position with upcoming regulatory procedures. Lack of preparation in terms of EUDAMED, reduced number of notified bodies and the cherry on top – confusion over Corrigendum 2, means that requirements that need to be fulfilled by May 26th 2020 aren’t as clear cut, but regulation never really is clear, is it?
Here are a few takeaways for class I medical device manufacturers. As always, we welcome questions and would love the opportunity to support your business during this difficult period.
- If your Class I medical device gets up classified under the MDR, and/or require notified body involvement for certain functions then you will benefit from the extended transition period (under Corrigendum 2). This means that, provided there are no significant changes to the intended purpose and that a valid declaration of conformity is in place prior to 26th of May 2020, your device will have until 26th of May 2024 to get MDR certified. Having said that, you do still need to comply with key aspects of the MDR by 2020: post-market surveillance, vigilance and registration of economic operators.
While 2024 seems like a long way away, the reality is that notified bodies will be saturated and likely to prioritise existing customers. Planning at the last moment is a recipe for trouble.
- If your Class 1 medical device remains unchanged under the MDR then you are going to have to be fully complaint by 26th of May 2020. This is quite a big step for Class I medical device manufacturers as firstly, they need ISO 13485:2016 plus QMS. Also, clinical evaluations will likely need to be redone as more input data will be required, specifically from active post-market surveillance which was not commonly done previously.
Here is a list of things we at RNI can help you with during this period of transition for Class I medical devices:
- Gap analysis between MDD and MDR and development of an action plan
- Review and update SOPs and technical files
- Post marketing surveillance plans
- Post marketing clinical follow up
- Clinical evaluation reports
- Biological evaluation reports and planning
- Risk management procedures
- Update agreements with economic operators
- Internal audits
RNI is here to help. Do get in touch and we’ll work with you to ensure you are ready for 26 May 2020.