What are the challenges for companies through the new medical device regulation?

What are the challenges for companies through the new medical device regulation?

On May 25th this year, the new medical device regulation came into force (“MDR” for “Medical Device Regulation”). This has significantly increased the workload for affected companies, as the new directives set high and changed requirements. There will inevitably be work peaks due to that.

Support for increased workload by the Medical Device Regulation

Many companies won’t manage the increased workload caused by the new directive coming into force by internal resources alone. At K-Recruiting, we specialize in supporting our customers for exactly these situations. Our excellent network of freelance consultants enables us to quickly and easily find competent experts to help out.

 

The new medical device regulation in detail

The MDR is a European set of rules which, in conjunction with the IVDR (EU Regulation on In Vitro Diagnostics), replaces existing medical device directive. Its predecessors have been the MDD (93/42 / EEC directive on medical devices) and the AIMD (90/385 / EEC directive on active implantable medical devices). For the IVD (98/79 / EC Directive on in vitro diagnostics), the IVDR has its own new regulation. The new MDR essentially changes the following:

  • “Scrutiny Process”: In the future, expert groups in high-risk medical devices can stop the certification process if deficits persist. This includes, among other things, breast implants and pacemakers.
  • Strengthening of clinical trials and assessments: In the future, the MDR will make it obligatory that clinical data continues to be documented and evaluated even after the launch of medical devices.
  • Introduction of Eudamed: This pan-European database is now collecting information on all EU-wide medical products to increase transparency.
  • UDI (Unique Device Identification): This product number (a combination of numbers and letters) is new in the form it will be now used, and is given only once for each medical device. This allows faulty products to be identified and tracked more quickly.
  • Tightened Control: The rules for the “notified bodies”, i.e. the state-recognized control entities, are tightened. A new review and selection of notified bodies will be carried out.
  • There are other significant changes. For example, the new regulation increases the requirements for technical documentation, the labeling is subject to new requirements, and manufacturers have to appoint a qualified person in their company with qualified medical device expertise. For the so-called high-risk products “special notified bodies” are introduced. In the future, the EU Commission can define “common specifications” when it considers that harmonized standards are insufficient or lacking. The requirements for products containing hazardous substances have been tightened considerably. For some products, the classification changes. Some implants with the current classification in class IIb are now class III along with higher requirements. Even the reprocessing of single-use products is now subject to stricter regulations, and previous PLM / OEM designs are no longer acceptable.

Consequences of the Medical Device Regulation

The consequences are mainly affecting the manufacturers. Their documentation effort will increase significantly. In the event that a product does not have an EU declaration of conformity or incomplete technical documentation, the market surveillance authorities may determine the official non-conformity of the product in accordance with Article 73 (1) (d, f) of the new regulation. The manufacturer shall then be given a reasonable period to achieve conformity. The authorities may take back market authorization of the product after the expiry of the time limit without sufficient results. According to the current state of knowledge (at the beginning of June 2017), there are no major changes for operators. In its currently valid form, operating laws remain unchanged as a nationally valid medical device operator ordinance.

 

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