Page content

article content

The new MDR and IVDR legislation. Are you ready for it?

New European regulations are coming to improve the safety of medical devices and in-vitro diagnostics. The regulations will come into force in 2020 and 2022. As a European product owner/OEM, you’re properly preparing for this legislation. But you’re also dependent on your suppliers. If you, for example, have a lot of foreign suppliers that don’t comply or don’t want to comply with the new legislation, you run the risk that your product may not be sold on the European market.

The newest decrees in the Medical Device Regulations (MDR) and the In-Vitro Diagnostic Regulation (IVDR) don’t just apply to market approvals of new products, but also to products that are already on the market. There’ll be stricter inspections and stricter admission requirements. In many cases, more evidence is also needed for the functioning of the products and there must be complete transparency and tractability of and surrounding a product and parts of the product.

Major consequences

For European manufacturers/OEMs of medical devices and in-vitro diagnostics, the new legislation has major consequences. Among others, they’ll deal with stricter requirements for labeling, the technical documentation and the quality management system. The manufacturers must also comply with the newest requirements for the unique identification code and all obligations of registration. They’re also obligated to hire a person that is specifically responsible for compliance with the legislation.

Suppliers outside the EU

It’s already quite the task for European manufacturers or product owners of medical devices and in-vitro diagnostics to comply with the new legislation themselves.  But their suppliers must also be able to move with the new legislation. Naturally, when concerns the technical functioning and composition of the products, semi-manufactured products and production parts, but also delivering the proper documentation, product codes and the traceability of product compositions. Especially the procedures and precision in the document flow can be a huge challenge for many suppliers outside the EU. Still, the European OEMs can’t afford any risks under the new legislation.

Security

Alligator Plastics have been working for manufacturers/OEMs of medical devices and equipment for years. We’re informed about the new legislation and, as a European company, are properly preparing for it. With us as a supplier of plastic and injection molded products and parts for your medical application, you’re guaranteed that we comply with the new MDR and IVDR. You’re not at any risk in this regard. Additionally, Alligator Plastics has experience in complying with the strictest market requirements. In July 2018, we attained the IATF 16949-certificate for the automotive branch. The ISO 9001-certification was part of this audit. The certificates show that we have properly laid out our processes and comply with them. We also apply these processes to all clients.

Do you want to know more about how we comply with the new MDR and IVDR? Call or email Bart van de Krol, our sales manager for the medical market. +31(0)622933353 or b.v.d.krol@alligator-plastics.nl.

Want to know more about our plastic injection molded products and parts for medical applications? Click here