Regulatory Background

The standard-compliant and consequently sustainable development, production, sale and application of medical products absolutely requires the adherence to a large number of regulations, some of them generally accepted, some of the country specific. At this point only the most general formulations in line with normal industry standards shall be mentioned. The binding norms for your product, production environment and sales area – and how these can be most effectively implemented – has to be the subject of an actual individual case study.

Here you find an overview of the most common rules and regulations of the environment:

GMP

The set of rules of the Good Manufacturing Practice (GMP) originates (at the beginning of the 60s) in the pharmaceutical industry and provides an internationally recognized standard for the production of substances and medicinal products. A quality management system in accordance with GMP guarantees product quality and compliance with requirements set by the health authorities for the sale of products. In the meantime additional standards, for example the Good Documentation Practice (GDP) or Good Laboratory Practice (GLP) have been derived from the GMP. Many rules and regulations that are valid for medical technology also follow this high and internationally as fundamental recognized standard.

DIN ISO 13485 (2016)

The DIN ISO 13485 is the ISO-Norm describing a comprehensive quality management system for the design and production of medical products. It is originally based on DIN ISO 9001 and is considered as the so to speak “mother of all norms” for designer, service providers, producers and distributing companies of medical products in Europe. For these market participants the DIN ISO 13485 is mandatory, its implementation or compliance with is subject to regular auditing by so-called notified bodies (for example TÜV, Dekra).

In addition to DIN ISO 13485 there is a range of product or product specific norms that have to be adhered to as well, for example the norms of sterilization and packaging. The DIN ISO 13485 was last updated in 2016 and has now become binding, the transitional period expired in march 2019.

MDD / MDR

The European Medical Device Directive, abbreviated MDD, or Directive 93/42/EEC, is being implemented in Germany via the  Medizinproduktegesetz (MPG) (Medical Product Law). In May 2017 the new regulation regarding medical products (EU) 2017/745 entered into force. Another name for it is Medical Device Regulation (MDR)  and it is valid without implementation in national laws. With a transitional period of 3 years the MDR replaced the MDD.

21 CFR 820

Im 21 CFR part 820 (Code of Federal Regulations) the FDA (Food and Drug Administration) states the requirements for the quality management systems inter alia for medical product producers. The 21 CFR part 820 is therefore the equivalent to DIN ISO 13485. The FDA even considers the recognition of ISO 13485:2016 as proof of a QM system. The demands of the FDA in the eyes of most authorities constitute the „gold standard“ with the result that the standard formulations of the 21 CFR 820 have to be met for the production and sale of medical products in their country. Consequently, the compliance with 21 CFR part 820 should not be limited to the intended sale of products in the USA.

© 2020 doering-pqm.com. All Rights Reserved.

DEUTSCH