What does it mean for manufacturers?
On 5th April 2017 the European Parliament voted to adopt the long awaited Medical Device Regulation (MDR) and In vitro Diagnostic Regulation (IVDR)
Publication, entering in to force and transition
The MDR regulation will replace the current medical device directive (MDD) and the active implantable medical device directive (AIMD), whereas the IVDR will replace the In vitro diagnostic directive (IVDD).
The official publication of the recently adopted regulations is expected within the next few weeks, formally commencing the transition periods. It’s important that manufacturers familiarize themselves with the requirements of the new regulations early in order to plan for a successful transition.
The transitional period is detailed in the new MDR articles 120-123 allowing a transition period up to 3 years from final publication date therefore expected Apr 2020. The IVDR allows a transition period of up to 5 years.
Certificates issued under the existing MDD remain valid for a limited period after this date allowing products to be placed on the market; however, no significant changes can then be made to the products, the quality system or the company. Likewise, there can be no certificate extensions in this period.
What's new and what's changed?
The changes to the MDR and IVDR are often seen as a revision of the requirements, but in reality, it is a new regulation, and should be handled as such.
In general the concepts and the requirements of the MDD and IVDD remain part of the new legislation but significant additional requirements have been added and changes made. There are a
number of new requirements that manufacturers need to address before an application for certification to the MDR and IVDR can be made. For example:
New Structure and level of details of the contents for the technical file. (Annex II of the MDR)
Establishment of compliance with ”General safety and performance requirements.” (Annex I of the MDR)
Requirement for a ”person responsible for regulatory compliance” to be appointed within the manufacturer. (Article 15 of the MDR)
New/revised procedures to be implemented to handle the new requirements including entering information into the databases. (e.g. Eudamed.)
Strengthened requirements for post market surveillance, clinical evaluation, post market follow up and clinical investigations (Annex III XIV & XV). It should be noted that the processes for post market surveillance/Post market clinical follow up should implemented as soon as possible, as the data generated will be very useful for documenting compliance to the new requirements when you apply for MDR or IVDR.
Requirement for ”summary of safety and clinical performance” for Class III devices and implantable devices. (Article 32)
Generally, the conformity assessment system as we know it from the MDD is maintained. There are changes to the classification rules, why some products are now assigned a higher class, requiring a more demanding conformity assessment process (for example, some products that used to be IIb are now class III and thus subject to a design examination.) In addition to this the assessment process at the notified body has increased in complexity and especially for class III & IIb implants and Infusion devices the scrutiny is increased.
Implementation of Unique Device Identification system (UDI) processes and marking. The requirements for the UDI system are given in several articles (27, 28, 29 etc.) as well as annex VI.
Once implemented, the Notified Body will need to conduct a new certification audit of your company. The certification process is initiated with a new application for certification and will originate a new certificate valid up to 5 years. The certification activities include assessment of technical files (Class IIa, IIb), evaluation of the design (Class III), evaluation of the quality system for compliance, and finally an on-site audit where implementation is verified. If the manufacturer has outsourced significant activities or are using crucial supplier, an audit of these may be needed before the certification process can be finalized and the certificate issued.
For In vitro Diagnostic Devices it should be noted that the types of devices that requires Notified Body involvement is significantly higher than it is under the IVD directive.