A brief overview - what is changing

MDR - History

The previous regulation - the Medical Device Directive (93/42 / EEC) and the Directive on active implantable medical devices (90/385 / EEC) - is in line with the Medical Device Regulation (MDR) passed by the European Council on 05.05.2017. replaced. The new EU regulation entered into force on 25.05.2017. It will result in massive changes for medical device manufacturers across the EU market.

There is a transition period for products that have already been approved in order to meet the requirements in all respects.

However, those who believed that there were delays and another postponement were soon instructed otherwise. Despite all resistance, the transition periods have not yet been extended!

MDR - Transition - Medical Device Regulation

ESSENTIAL CHANGES

Medical Device Regulation

Greater scope

Now more products are covered by expanding the definitions in the field of medical devices and active implantable medical devices. For example, colored contact lenses are now also included - but also implants and fabrics for aesthetic purposes. Devices for predicting the risk of disease are now likely to fall within the scope of the regulation.

Reclassification of products

The manufacturers of medical devices have to test their products according to the new classification rules. The technical documentation must be updated accordingly. According to the classification of the product in the respective class, there are different requirements when implementing the regulation. Class III medical devices and implantable devices are subject to stricter clinical requirements - including regular monitoring.

Notified bodies

The powers of the notified bodies with regard to clinical monitoring are being expanded. Unannounced audits, spot checks and product tests are intended to strengthen the enforcement of the regulation.

Unique product number

A system of unique product numbers (UDI) is introduced. This allows products to be traced and recalls are possible. Manufacturers must implement this, apply for the UDI of their products and label them accordingly.

After placing on the market - Strict requirements for clinical monitoring

The new MDR requires annual reports on the safety and performance of your products for defined product groups.

Manufacturers who do not have sufficient clinical evidence must conduct clinical trials. In addition, manufacturers must collect and archive clinical data to continuously assess potential safety risks.

Determination of a responsible person

Manufacturers of medical devices must designate at least one person who is responsible for complying with the above Regulation in your company / organizational unit. Proof must be furnished that this person is sufficiently qualified for this.

However, these listed points represent only a small - not exhaustive - compilation of what we consider to be significant innovations.

In any case, we recommend that you check the IVDR for a specific product with regard to the respective requirements.


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WHAT CAN YOU DO AS A SUBJECT?

As a manufacturer of medical devices, you are fundamentally faced with a complex and time-consuming process. You cannot avoid this process, as there is ultimately no inventory protection for products on the market.

We recommend you as a manufacturer of medical devices:

  • do not let unnecessary time pass since the procedure will in any case be complex. Further delays can also be expected due to the reduction in the number of notified bodies.
  • Think about a strategy for implementing the new MDR in your company. Consider time-consuming contacts with Notified Bodies and possibly other authorities.
  • If you have any doubts about the classification of your products in the appropriate class of the new MDR, contact the Notified Body in good time (or hire an external service provider) - assume that other companies will also have this problem.
  • Make a decision whether you want to take over the entire process yourself and / or if you want to hire a (proven and potent) consultant.

Our experience - your advantage

Whether it concerns the approval of your medical devices, individual questions about this procedure or services related to it, we can draw on the extensive experience of our employees in this field and related areas.

Exclusively for our clients and together with our team of doctorate-holding specialists, we offer you the consultancy services of actively practicing medical doctors with their knowledge in the fields of medicine, medical technology and medical informatics.

  • Experience of more than 30 years within the scientific and clinical field
  • Your technical documentation will be prepared by experienced employees with appropriate degrees (including doctoral degrees in life sciences).
  • Based on our experience, we will prepare your documents promptly, to a sufficient but not excessive extent, in a standard-compliant manner.
  • We assume all related services in a highly qualified manner - we will support you until a successful completion.

For your information:
The full text of the regulation can be found on the EU public website. Go to the legislation text

Available services offered by QiP GmbH

Our team undertakes for our clients or supports them with the following services (exemplary):

  • Contact with the Notified Body, agreement on the classification of the product
  • Creation and updating of documents
  • Independent clinical evaluations
  • Market monitoring, market analyses, PMS, PMPF, PSUR, safety reports
  • Vigilance (trend reporting, serious adverse event reporting and analysis, field security corrective actions)
  • Collection of clinical data
  • Master plans, overviews, evaluations
  • Quality and safety reports
  • Monitoring of corrective and preventive measures (Action Plan) according to the CAPA procedure
  • Risk management (including risk analysis, risk assessment, risk control)
  • Support with the approval process
  • Technical documentation
  • Support in the preparation of clinical studies
  • Checklists

We can basically accompany you in all points of the procedure. We would be happy to advise you free of charge and without obligation on a possible service package for your specific product or project.

The first step is sometimes the easiest - but also the most important:Contact us


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