Medical Device Directive: What remains unchanged?
The changes are significant. Nevertheless, some core concept remained unchanged:
- No regulatory authority/agency: There won’t be a European agency granting market access comparable to the European Medicine Agency EMA for drugs or the FDA for drugs, medical devices and more.
- Manufacturers still declare conformance (with the CE mark) after following a conformity assessment procedure. The conformity assessment procedures still depend on the class of the devices. With exception of class I devices, notified bodies still have to be involved.
- The classification essentially is unchanged. Exceptions are mentioned below.
- Harmonized standards remain a way of proofing compliance. However, the EU additionally introduces the concept of “common specification” (see below).
- Non-EU-manufacturers can import medical devices. One of the prerequisites still is an EU representative.
MDR: What is new?
The Medical Device Regulation is a document spanning more than 550 pages – a multiple of the Medical Device Directive MDD. The MDR introduces numerous new requirements and concretizes requirements of the MDD.
- Essential requirements
The essential requirements – now renamed as “essential safety and performance requirements” – are much more specific. Consequently, the technical documentation is closer regulated. There is a comparision between MDD and MDR requirements.
- UDI & Labeling
Like the FDA, manufacturers now must assign a unique device identification (UDI). This UDI consists of a device identifier and a production identifier. The UDI is not the only change to the labeling requirements.
- New roles
Manufacturers must employ (exception for small companies) a “person responsible for regulatory compliance”. Other "economic operators" include roles such as the distributor, the EU representative and the importer.
Not only the UDI data must be submitted to the EU database (EUDAMED), but also (dependent on the class) post-market data (e.g. a “periodic safety update report”) .
- Clinical Evaluation and PMCF (post-market clinical follow-up)
The MDD was addressing the clinical evaluation only on one page and the post-market clinical follow up (PMCF) not at all. The MDR exactly describes respective requirements in several articles and a comprehensive annex.
- Post-Market Surveillance
The post-market surveillance, that was barely addressed in MDR, now is regulated in detail.
- Placing on the market, conformity assessment procedures
The conformity assessment procedures were changed: There is no longer a procedure comparable to Annex VI of MDD. Additionally, for high risk products (some class IIa and most of class III products) additional procedures must be followed and the notified bodies must consult expert groups/panels (scrutiny).
The classification rules now take active implantable devices, nano-materials, and substances introduced into the body into account. A new classification rule 11 specifically addresses software – major reclassifications are expected.
- Common specifications
The EU commission entitles itself to introduce “common specifications” (CS) if harmonized standards are lacking or insufficient. So far there is no standard harmonized nor any CS published.
EU Regulations versus EU Directives
It is also important to understand, that EU regulations are effective in all EU countries with date of publication. In contrast, the EU directives must be implemented in national law first.
There will be still national laws e.g. to define fines. However, the essential requirements manufacturers and importers must comply with are laid out in the MDR.
Switzerland, a non-EU country, stays part of the EU-system.
Main Differences to US / FDA Regulations
The requirements of the new medical device regulations are much closer to the FDA requirements. Nevertheless, manufacturers that already have a FDA clearance must consider:
- A successfully passed conformity assessment procedure is a prerequisite.
- Apart from class I products this means an involvement of notified bodies and a quality management system compliant with ISO 13485.
- Manufacturers must prove conformity typically by applying harmonized standards such as IEC 62304, IEC 62366 and ISO 14971. Fortunately, these standards are very comparable to FDA requirements as expressed in guidance documents.
- Obviously, the medical device reporting is different. This does not only apply to form and addressees.
- The EU has dedicated requirements to “economic operators” such as importers, distributors, EU representatives and to the “person responsible for regulatory requirements”.
- The requirements with respect to clinical evaluation and post-market clinical follow-up are different (partially higher).
Medical Device Regulation (MDR) at a glance
The Medical Device Regulation MDR consists of 10 chapters that group in total 123 articles. MDD consist of 23 articles.