Since May 2017, a new Medical Device Regulation (MDR) came in force with a transition period of three years. Medical Device manufacturers have until the end of 2019 to comply with it. The scope of this regulation has increased as even some non-medical products as cosmetic contact lenses and esthetic surgical implants are included (Annex 16). For manufacturers of such devices, this new regulation can be critical as they are not used to such requirements.
Additionally, more responsibility is now placed on the shoulders of distributors and authorized representatives. Even the Notified Bodies, who deliver the certificate to manufacturers, have more specifications to follow to get licensed. So our advice would be also to get in close contact with them to know if they are able to follow them as this can put your certificate at risk as well as your business. In this article, we will guide you through the major changes and would ask you to take action now and not to wait anymore.
Product classification remains I, IIa, IIb and III, but there are some changes on products. Major changes are for spine intervertebral cages. They were class IIb and now will become class III (Rule 8 – Annex 8). Other changes are related to products containing nanomaterials which are now included on the classification (Rule 19 – Annex 8). If you have such products, you have to check what additional actions need to be performed. Furthermore, make your notified body review the Technical Dossier as soon as possible as resources are not extensible. At the same time your competitors will do the same, so First In First out.
New Product Development or Products on the Market
If you are currently developing new products, I would ask you not to stop now, but to pause and check if you will be compliant with the new MDR. This is essential as all legacy products will have to comply with the new regulation. This will require some strategy from your side as this can take some time. Reassess all technical files and ensure it’s reviewed by the notified body in case of major changes. Your business is at risk.
Single Use Device
A lot of debate took place to decide if Single Use devices are still authorized or not. Regulators were asking to prove that the device cannot be reprocessed before placing a “Single Use” logo on it. Now each National Authority will have to decide how to address this particularity. Reprocessors will need to be in close contact with the manufacturers of the product to provide the highest safety for patients.
One of the issues with Technical Files are the fact that there was no real guidance on how it should appear. Now it will be more rigid in terms of content. More requirements for Quality System Management is included and also the concept of new common specification.
More clinical data are required to manufacturers. If they haven’t already reviewed all their Clinical Evaluation Reports (CER) they will need to assess that the Postmarket Surveillance data are included.
Vigilance and Post marketing Surveillance
When reviewing the safety risk of their product, manufacturers will now need to collect postmarketing clinical data more regularly. The consequence is a change on the procedure that should be implemented if not already done to include the clear responsibility of the collection of those additional data.
Mandatory Product Liability Insurance
Manufacturers should provide proof of coverage on product liability. The assistance of a legal counsel will be needed to act rapidly in case of a product liability provision.
Manufacturers should be transparent and would need to keep a close eye on the European Data Bank on Medical Devices (EUDAMED) to notify all products once they have been implemented. The general public will have access to this new tool to be adequately informed. But this database will be implemented by May 26, 2018.
Labelling and Supply Chain
Manufacturers should appoint a person responsible for regulatory compliance (PRRC). For European Authorized Representatives (EUAR), there are also more requirements to fulfill.
In the supply chain, labeling requirements will be more prescriptive. The use of the manufacturer’s website will be needed to keep all the data up-to-date. For Notified Body numbers, they should remain the same for the ones that pass the new requirements, so this will avoid the requirements for a change of all your labels (Article 43).
This technology used in the U.S. is now mandatory also for the EU. Compliance to this should be implemented now. For those already selling products in the U.S., this should not be a major issue. For those that haven’t started a project to comply with this rule I would recommend it is made a priority or you will not be able to sell your products anymore.
The new Medical Device Regulation is now alive and we cannot be stopped. Manufacturers look at the transition period as a chance because they think they have time to implement all the new requirements, but in reality it will not work if they have no team in place. The project should not be considered as a quality or a regulatory project but should be composed of members from all departments. Some of the changes can take time (UDI implementation, labelling requirements…) as a complete change of the supply chain should be done. Others require a review of the entire portfolio.
So involvement of consultants could be a need which means that a budget should be allocated to it. This new MDR will be a revolution for our medical device manufacturers and also to some manufacturers of non-medical devices. Some will succeed and some will not be able to continue. So try not to be the one that will be left behind.
*For more information on the implementation of the MDR 2017/745, visit Monir’s site: Easy Medical Device