The MDR concerns everyone
The first experiences
On 25 May 2017, the EU regulations MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostics) came into force and they will replace the existing medical device directives. We already reported on this in our article „Medical Device Regulation (MDR) – A risk for the medical device industry?“
With today’s article we would like to once again awaken a common understanding for the MDR (Medical Device Regulation) and show with a few examples how complex the requirements and challenges are. In fact, the MDR (Medical Device Regulation) concerns everyone. And for successful implementation in the company, valuable input from all departments is required.
When the European Commission introduced the MDR (Medical Device Regulation), it had one particular goal in mind: patient safety should always be better guaranteed than in the past.
And so, of course, many points of the MDR (Medical Device Regulation) are aimed at achieving this goal.
Companies‘ reactions to the MDR varied greatly. While some went very quickly, albeit perhaps not planned, into the implementation of individual aspects, others continued to hold back and arguing with the quite long implementation deadlines, in parts until 2020.
In the past year we have repeatedly encountered statements such as „… my department is not affected by this“, „This primarily concerns Notified Bodies“, „This regulates regulatory affairs at our company“. Have these assumptions held in practice? Let us take a look at the examples below.
The Scrutiny procedure – only an additional effort for the Notified Body?
In support of the goal for more safety for the patient, the MDR (Medical Device Regulation) says „For [certain products] Notified Bodies […] should be required to instruct expert panels to review their clinical evaluation reports.“
Article 54 of the MDR (Medical Device Regulation) lists which products are affected.
In any case, we can state at this point that this procedure – insofar as it is neccessary – will take a considerable amount of extra time, justified by the additional involvement of the expert panel and also by the preparation of the „clinical evaluation assessment report“ by the Notified Body, which always precedes the expert panel.
Although the actual action here is a task for the Notified Bodies, this point has a decisive influence on the manufacturers. Today it can be assumed that the Notified Bodies will be paid for these additional time and efforts, so these additional costs must be included in the manufacturer’s calculation.
The manufacturer must also keep in mind the additional time and take it into account in his planning. This clearly also means a later market access for the product.
Clinical evaluations and trials – only a topic for clinical affairs?
MDR (Medical Device Regulation) requires manufacturers to collect and evaluate clinical data. To this end, it also specifies in the definition which sources must be taken into account by the manufacturers at least.
The requirements are listed inter alia in Article 61, Annex II/ Chapter 6 and Annex XIV Part A and Part B of the MDR (Medical Device Regulation).
Because clinical trials are expensive and usually take months to years, manufacturers often try to use clinical data from comparable products to avoid the cost and time required for clinical trials.
The challenge was always that the reference products had to be „sufficiently similar“. The MDR (Medical Device Regulation) has further tightened the requirements at this point.
Three aspects must be taken into account in terms of equivalence:
- the technical aspect
- the biological aspect
- the clinical aspect
Close cooperation with product management, health economics & reimbursement and research & development can help to find and select the right reference products in a short time in order to avoid additional costs for clinical studies in the “best case” scenario.
All departments should be informed that manufacturers are required to systematically collect and evaluate both preclinical and clinical data on the product. This is the only way to ensure that product-related data is always up to date and thus avoid unnecessary costs.
Supplier relations under scrutiny – a challenge for purchasing!
The cooperation between PLM (Private Label Manufacturer) and OEM (Original Equipment Manufacturer) is today a not uncommon practice in the medical device industry, which has proven itself with benefits for both sides.
The MDR (Medical Device Regulation) has a considerable influence on this constellation, which requires well-considered and well-prepared action on the part of the manufacturers.
Article 16 of the MDR (Medical Device Regulation) describes, among other things, the obligations of importers, dealers and other persons who make products available under their own names or brands, which are then equal to the obligations of the manufacturer (Article 10).
Here it must certainly be examined in detail via supplier management or purchasing in the respective company to what extent the original manufacturer already fulfils these obligations today or can do so in the future in order to be able to continue in a successful cooperation under MDR (Medical Device Regulation).
Although Regulatory Affairs certainly deals with many points and changes of the MDR (Medical Device Regulation), the input from the related disciplines as well as the impact on these departments and the company should not be underestimated.
Experience from the past year has shown us that the successful implementation of MDR (Medical Device Regulation) can only be achieved here together and in coordination.
A lack of coordination or a lack of understanding of the effects on the various areas and the company as a whole may lead to unnecessary additional costs and delayed market access, which in turn can influence the strategic orientation of the company.
Get in touch with all areas in good time, awaken a common understanding, clarify the responsibilities and thus ensure successful implementation in your company today.
We wish you much success and are at your disposal for your questions and wishes.
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