On April 5th 2017, the new Medical Device Regulation (2017/745/EU) was accepted by the European parliament. On May 5th 2017 it was published in the European Official Journal (EUOJ), based on which it came into force 20 days later. As a consequence of this, a series of events was initiated which will cause a lot of changes for the producers as well as for the Notified Bodies.
First of all, the directive is replaced by a regulation. Different from a European directive, a regulation has a direct effect. This means that the regulation does not have to transfer into a national legislation.
We can’t determine our classification under the rules in EU MDR Annex VIII. What are our options?
Conformity assessments for many medical devices have changed under the MDR, and classification must be reevaluated based on the new rules. The changes in the conformity route could require additional performance testing and/or clinical evaluation. Evaluating your device classification is essential to ensure that your company can allocate the time necessary to keep marketing their products in the EU. However, some classifications will remain unclear for some manufacturers, and companies will need to contact their Notified Body for assistance to make sure they understand the proper classification and conformity route. In some cases, if there is a dispute, the classification request will be forwarded to the competent authority for a final decision. If your device classification has changed, you should be able to pursue MDD certification renewal and that may be advantageous if you are unsure whether your device has adequate clinical data to support MDR certification.
Why take the time to do an MDD-to-MDR gap analysis?
Conducting a detailed analysis regarding the new MDR requirements is essential. For instance, a change relative to the classification generally implies extra documentation requirements, additional clinical investigation, and a comprehensive risk management review.
It is crucial to consider the timing when conducting a product portfolio assessment, since satisfying any new requirements is not insignificant. Existing design dossiers or technical files must be up to date with the additional mandated requirements when maintaining current MDD certificates past the effective date of the MDR. New application files submitted to the Notified Body after the MDR effective date must meet current MDR requirements along with quality system certification to the new MDR.
Also, additional clinical data may be mandatory depending on the status of the current product portfolios, so include the planning and implementation in your timeline. Toward the beginning of 2021, maintenance of the documentation to the MDR standards will be necessary, while the products that remained certified to MDD will also need to be recertified to MDR.
MDR transition strategy = good business strategy
It is imperative for all medical device manufacturers, as part of the business strategy, to concentrate on accessing their product portfolios and prepare a plan for the timely transition to the MDR. There are limitations worth considering when choosing to commercially distribute legacy medical devices under the old regulatory framework of the MDD. There must be no significant changes – including labeling and packaging changes, which are quite common.
Manufacturers must recognize that not all design changes are foreseeable or predictable, and could likely require recertification to the MDR. For instance, the manufacturer receives a new reportable adverse event requiring a significant labeling update. Maintaining compliance to the MDD EC Certificate after June 2020 would prohibit implementation of this change. Yet, based on this adverse event, the Competent Authority may request corrective action on the labeling change, which would now suddenly propel the company into the MDR transition.
Conduct a thorough gap analysis and create a plan soon
If you are in the midst of planning your EU MDR transition timeline strategy, need help deciphering the requirements, or want any consultancy MAVEN can help. We can conduct a comprehensive EU MDR gap analysis and formulate a clear EU MDR transition strategy and/or train your team.