The Medical Device Directive is Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, commonly abbreviated as MDD in professional practice. Alongside Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices, it formed the central legal framework for medical devices in the internal market. As a directive, it was not directly applicable but had to be transposed into national law; the implementing regulations were to be adopted by 1 July 1994 and applied from 1 January 1995. With effect from 26 May 2021, it was repealed pursuant to Article 122 of Regulation (EU) 2017/745, but remains relevant for legacy products to the extent that the transitional provisions of Article 120 refer to it.
Structure and Organization of the Directive
Directive 93/42/EEC was structured much more leanly than the current Regulation, consisting of 23 articles and several annexes. Annex I contained the Essential Requirements, divided into general requirements and requirements regarding design and construction. These included, among other things, acceptable risks in relation to the beneficial effect, a strict hierarchy of risk elimination, protective measures, and information on residual risks, as well as the achievement of the performance levels specified by the manufacturer. Article 9, in conjunction with Annex IX, regulated the classification into classes I, IIa, IIb, and III; Annex IX provided the definitions and rules for this, including the duration categories of transient, short-term, and long-term.
The conformity assessment procedures were set out in Article 11 and Annexes II to VII, with options available depending on the device class; Annex II was based on a full quality management system. Articles 5 to 7 established harmonized standards, while Article 17 covered CE marking. The Directive was not substantially amended until Directive 2007/47/EC, which clarified that standalone software can also be a medical device, required software lifecycle processes, and mandated that risks arising from a lack of usability be considered within risk management.
Distinction from Regulation (EU) 2017/745
The first difference is the legal form: A directive binds the member states and takes effect through national laws, such as the German Medical Devices Act, whereas a regulation is directly applicable. The second difference is the terminology: The Essential Requirements of Annex I of the Directive became the General Safety and Performance Requirements (GSPR) of Annex I of the Regulation, which are much more detailed and explicitly include a risk management system. The third difference concerns classification: The rules of Annex IX were adopted into Annex VIII of the Regulation and tightened, particularly for software and substance-based products.
Furthermore, the Directive did not include a differentiated clinical evaluation as a process with an evaluation plan, no Person Responsible for Regulatory Compliance (PRRC), no Unique Device Identification (UDI), no European database for medical devices (EUDAMED), and no obligation for Periodic Safety Update Reports (PSUR). The continuation of the legal status for products with a directive certificate is described in the entry for legacy products; the current Regulation itself is the subject of the entry EU-MDR 2017/745.
Why Legacy Certificates and Legacy Data Remain Relevant
Certificates issued by Notified Bodies under the Directive do not lose their significance on the date of repeal. According to Article 120(2) of the Regulation, they remain valid beyond the printed expiry date under certain conditions, and Article 122 stipulates the continued application of the Directives for products covered by Article 120, as far as necessary for the application of these provisions. Anyone placing such products on the market today must still demonstrate that they comply with the Directive and have not undergone any significant changes in design or intended purpose.
Data collected under the Directive also remains relevant. Clinical experience, literature reviews, complaint evaluations, and registry data from the Directive era often form the basis of clinical evidence when transitioning to the Regulation. However, they must be reviewed against today’s requirements for data quality, proof of equivalence, and post-market follow-up, as the Directive had lower requirements for data provenance. The historical classification status also remains significant for the deadlines and obligations of legacy products.
Relevance for clinical trials
In ongoing programs, one regularly encounters mixed datasets: trials started under the Directive and the national regulations applicable at the time, and follow-ups continued under the Regulation. The decisive factor is whether the study protocol, informed consent, data protection basis, and documentation meet current expectations for traceability and whether the investigated product version corresponds to the product being evaluated.
For the planning of new data collection, the historical framework primarily means a gap analysis: which evidence was never required under the Directive and is therefore missing, such as long-term performance, user groups, or usability. Full-service CROs like Mediconomics support manufacturers in systematically reviewing legacy data, assessing its usability, and defining the remaining study requirements so that the documentation meets the requirements of the current Regulation.
Frequently Asked Questions (FAQ)
Is Directive 93/42/EEC still applicable today?
It was repealed with effect from 26 May 2021. However, for products falling under the transitional provisions of Article 120 of Regulation (EU) 2017/745, its provisions continue to apply as far as necessary for the application of these transitional rules.
What distinguished the Essential Requirements from today’s requirements?
The Essential Requirements of Annex I of the Directive were formulated more concisely and openly. The General Safety and Performance Requirements of the Regulation are more detailed, require a risk management system, and impose additional requirements on software, labeling, and instructions for use.
Can clinical data from the Directive era still be used?
Yes, provided that its origin, quality, and assignment to the evaluated product are documented. It must be integrated into the clinical evaluation according to current standards; any identified gaps must be closed through new data or post-market clinical follow-up.
Regulatory References
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices – Annex I, Article 9 and Annex IX, Article 11 and Annexes II to VII, Article 22.
- Directive 2007/47/EC – Amending Directive 93/42/EEC, including provisions on software and usability.
- Directive 90/385/EEC on active implantable medical devices – parallel directive, also repealed.
- Regulation (EU) 2017/745, Article 122 – Repeal of the Directives with effect from 26 May 2021 and continued application for transitional products.
- Regulation (EU) 2017/745, Article 120 – Transitional provisions for products with a directive certificate.
