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Medical Device Regulation – what are the new requirements for (practice) laboratories?

A short overview on what is needed to be done by Debora Engel, Regulatory Affairs Management Amann Girbach.

Thu. 3 February 2022, 12:00 AM

Medical Device Regulation – what are the new requirements for (practice) laboratories?

The Medical Device Regulation (MDR), which has been in force throughout the EU since 26 May 2021, brought with it several additional stricter regulatory requirements for dental laboratories and practice laboratories - both in terms of documentation as well as the post-market surveillance of products. In this context, it is also important to note that the responsibility for the final product always lies with the manufacturer of the custom-made product, in other words, with the laboratories. At Amann Girrbach, we have addressed the new specifications and regulations down to the smallest detail and successfully completed MDR certification. To fully and precisely satisfy MDR requirements as well as providing follow-up measures, we wish to support laboratories in complying with MDR obligations and to facilitate their work. Significant relief for the laboratories is given in that our products feature barcodes and that all relevant product data are automatically created in the Ceramill Mind software when using our Intelliscan hand-held scanner - which assures end-to-end tracking. Furthermore, when using AG-Live, the patient cases can be assigned directly. All contents of the new Medical Device Regulation and details of the complex requirements and specifications can be found online at the website of the European Commission.

So, what are the essential regulations of the MDR?
We have listed the most important new regulations and the resulting to-dos here to give an overview of the requirements:

Risk management
The Medical Device Regulation stipulates that a risk management plan must always be established according to the risk management process. This should include: the assignment of responsibilities and authorities, risk acceptance criteria, a method for assessing the overall residual risk, criteria for accepting overall residual risk, activities to verify the implementation and effectiveness of the risk governance actions, as well as actions related to the collection and verification of relevant information from manufacturing and downstream phases. Risk analyses are prepared and updated based on the plan.

Declaration of conformity and retention period
The declaration of conformity, which is based on the previous Medical Devices Directive 93/42/EEC in terms of content but now refers to Annex I of EU Regulation 2017/745, must state the name and address of the manufacturing site of the product. The retention period has also changed - this is now at least ten years or even 15 years for implantable products.

CE mark is permissible for intermediate products
After some uncertainties, it has been clarified in the meantime: the CE mark is permissible for intermediate products. The CE-marking of intermediate products has the advantage for laboratories that the initial conformity assessment procedures have already been completed. Relevant evidence for the safety of the intermediate product has thus already been established - for example, the clinical evaluation or a risk management file. The fact that the CE marks are permissible makes it considerably easier to prepare one's own verification documentation for the final product.

Post market surveillance in place of complaints evaluation
The biggest new aspect in this area is that active post-market surveillance is required, an evaluation of complaints alone is no longer sufficient. Depending on the classification of the products, different post-market surveillance criteria must be observed. For products and custom-made devices of medical device Class I, a post-market surveillance report is to be prepared, which includes the collected post-market surveillance data and a justification for any corrective and preventive actions taken. A safety report must be prepared for custom-made devices of medical device Classes IIa, IIb and III. In addition to the above mentioned points, the safety report is to include conclusions from the risk-benefit assessment. Moreover, the total sales volume of the product and an estimate of the number and other characteristics of the persons for whom the product in question is used, as well as the frequency of product use, if applicable, are to be provided. For IIa products, the update must be carried out at least every two years.

Type and scope of the clinical evaluation for custom-made products
The field of clinical evaluation for custom-made products poses some complex questions in part. Some of these issues were answered and summarized in a separateQ&A document of the Medical Device Coordination Group on the website of the European Commission. However, what is clear is that the clinical evaluation should not be performed for each custom-made product, but rather bundled for defined product groups - products that, for example, consist of the same material and have the same intended purpose.

Responsibility for the final product lies with the manufacturer or laboratory
As the responsibility for the final product lies with the manufacturer, in other words the laboratory, it is all the more important that the laboratory familiarizes itself with the MDR requirements.

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