Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), Article 10, paragraph (8), explicitly requires manufacturers to establish a quality management system (QMS). The IVDR further stipulates in Article 8 that products that comply with harmonized standards are presumed to be in conformity with the requirements of that Regulation.
EN ISO 13485:2016/A11:2021 is currently the only standard that is harmonized with the IVDR regarding the establishment of a QMS. Manufacturers can therefore use an EN ISO 13485 certification to demonstrate that their QMS meets IVDR requirements.
MDSAP is beneficial for all manufacturers who wish to place their products on the market in the countries participating in the program (Australia, Brazil, Canada, Japan, USA). Compliance of the QMS and fulfillment of country-specific regulatory requirements is demonstrated with just one audit. Since the program's requirements are based on ISO 13485:2016, European manufacturers also benefit. However, they must ensure that they also meet the IVDR requirements.
In-house IVDs, also known as "lab developed tests" (LDTs), are also subject to regulation by the IVDR. Healthcare facilities that develop and manufacture in-house IVDs must also comply with the relevant IVDR requirements. Article 5 (5) specifies these requirements in detail. Among other things, the healthcare facility's laboratory must comply with the
EN ISO 15189 or, where applicable, national regulations, including national accreditation regulations.
Manufacturers who do not only manufacture IVDs have often also adapted their QMS to the requirements of
ISO 9001:2015. Certification to this standard is required for the product registration of non-IVDs in some countries. Among other things, the ISO 9001 QMS better reflects the company's quality awareness than the ISO 13485 QMS, which can lead to a competitive advantage.
Internal audits with Metecon auditors have proven their worth for our customers because we prepare you in the best way possible for QMS audits: Through an audit, our auditors check the effectiveness of your QMS and identify any weaknesses and potentials for improvement. After the audit, Metecon can support you in implementing appropriate measures so that you are well prepared for an audit by the notified body, certification body, or accreditation body.
We would be happy to discuss the advantages, the process, and the costs of an internal audit by our auditors with you.
Get in touch and we will work with you to determine how your next internal audit should proceed. 