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New European medical devices regulation – what manufacturers of medical devices and in-vitro diagnostic devices should take into account

After negotiations that extended over years, the new regulations for medical devices (Medical Device Regulation, MDR) and in-vitro diagnostic medical devices (In-Vitro Diagnostic Medical Devices Regulation, IVDR) were published on 05 May 2017.  The new regulations replace the present directives, 93/42/EEC, 98/79/EC and 90/385/EC.

 


Important reforms


Compared to the previous directive, the MDR comprises almost 100 articles more; the number of annexes increases from twelve to 17. In addition, the MDR is to be supplemented by 32 new implementing legal acts and another eleven delegated legal acts. The important reforms comprise, amongst others, the following points:


More stringent requirements for clinical assessment and testing
- More detailed regulations and requirements for clinical assessments and clinical trials
- Extensive requirements for post market surveillance (PMS), which must be implemented for each product


Stringent clinical post market surveillance
- Extension of the authorisations of the notified bodies with regard to clinical post market surveillance
- Annual reports on the safety and performance of the products by the manufacturer


Appointment of a qualified person
- Appointment of a person who is responsible for fulfillment of the regulatory requirements
- Proof of the qualification of the person who is responsible for fulfillment of the regulatory requirements


Implementation of the system of unique product numbers
- Requirements for a system of unique product numbers (unique device identification, UDI)
- Extension of the European database for medical devices (EUDAMED)


Extended consultation procedures
- For Class III implants and active medical devices of Class IIb for administration or removal of medicinal products, the notified body must notify the European Commission, who can then call in an expert committee to perform an assessment.


Common specifications
- Introduction of the regulative instrument of the "common specifications", which acquire validity both for the manufacturers and for the notified bodies
- These specifications apply in addition to possibly existing harmonised standards
- The European Commission reserves the right to define common specifications if the Commission is of the opinion that harmonised standards are lacking or are inadequate.


Classification system for in-vitro diagnostic devices
- Replacement of the lists of Directive 98/79/EC by a rule-based classification system, with the result that numerous products now have to be certified by a notified body.

 


Consequences of the regulations for the manufacturer


In particular, this entails the consequence of a considerably greater cost of documentation for manufacturers. Moreover, old products, too, have to be subjected to a renewed investigation and certification within the transition periods. Thus, both regulations will be applied in parallel until expiry of the transition periods.

After a three-year transition period, the regulations will become mandatory for all initial certifications and recertifications, starting from May 2020 (for medical devices) / May 2022 (for in-vitro diagnostic devices). Since the notified bodies will first be newly appointed, it is expected that manufacturers will not be able to subject their products to a conformity assessment procedure before the end of 2018/ start of 2019, with the result that the transition time period will be additionally curtailed. Regardless of this, manufacturers of medical devices and in-vitro diagnostic devices should start with the implementation of the new requirements.


How we support you


In order to continue serving you as notified body, we will apply for a comprehensive appointment under the new regulations. We will present essential contents as well as our way of proceeding in the scope of customer events in the 2nd half-year of 2017. We will furthermore extend our seminar programme to include the new regulations from the 2nd half-year of 2017 onward.


You can find the texts of the regulations at the following links:
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746

and in our download section.