The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Medical devices in the European Union not only make a significant contribution to the overall well-being of people, but they also account for one of the largest markets worldwide. In the European Union, EU Regulation 2017/745 is the legislation for medical devices.
The European Medical Device Regulation (MDR)
Non-EU based manufacturers are legally obligated to appoint an Authorised Representative (EC REP) in order for their products to legally circulate within the EU Market.
Whether a medical device requires a Notified Body (in the case of Class I sterile/measuring/reusable, IIa, IIb, and III) in order to obtain the CE Marking or the manufacturer is permitted to self-declare (simple Class I), non-EU based manufacturers are legally obligated to appoint an Authorised Representative in order for their products to legally circulate within the EU market.
The Authorised Representative plays a pivotal role in ensuring the compliance of the devices and in serving as contact person established in the Union. The minimum role of the AR encompasses a series of obligations, such as:
- To verify that the technical documentation and other essential documents have been drawn-up, and that the manufacturer has complied with his registration obligations.
- To provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device.
- To forward to the manufacturer any request by its competent authority for device sample.
- To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
- To immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
The EC-REP or EAR (European Authorised Representative) is jointly responsible for defective products and must terminate the contract with the manufacturer in case the manufacturer acts in a way that conflicts with their obligations. Consequently, the EAR is liable for defective products when the manufacturer has not complied with its obligations under MDR.
Actors and devices need to be registered in EUDAMED, the European Database of Medical Devices.
To improve market surveillance and increase traceability and transparency, the Medical Devices Regulation (MDR) has introduced EUDAMED, the European Database on Medical Devices.
EUDAMED consists of six modules:
- Actor registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
The economic operators that must register as actors are the manufacturer, authorised representatives, system or procedure pack producers, and importers. With the registration, economic operator receives the Single Registration Number (SRN).
Registration in EUDAMED is mandatory after the European Commission announces that the database is fully functional. From that moment, manufacturers will have to respect the following timeline to register:
- Within 6 months for actor registration.
- Within 24 months for device registration.
- Immediately in case of incidents.
The Medical Devices Regulation (MDR) has set out the figure of the Person Responsible for Regulatory Compliance (PRRC) and cleared out its role in relation to the authorised representative and to the manufacturer. Each authorised representative has to have their own PRRC, whose role is to ensure that:
- “Minimum mandate” between the manufacturer and the authorised representative fulfils all the requirements of the Regulations (MDR and IVDR), and it is signed by both parties.
- Authorised representative correctly performs the tasks as defined in the Regulations.
- Responsibilities as laid down in the MDR and in the mandate are fulfilled by the AR.
Each authorised representative has to have at least one PRRC, located in the EU. Manufacturers of medical devices must have a PRRC as well. Article 15 of the MDR defines the minimum requirements that a PRRC must have to be designated as such.
For both the EAR and the manufacturer, the PPRC has to be permanently and continuously at their disposal.
Notified bodies play a key role in supporting manufacturers of medical devices to place only safe and compliant medical devices on the EU Market. They are assessing the manufacturers by carrying out conformity assessment procedures and issue conformity certificates
Notified bodies are third-party conformity assessment bodies, that verify the production and the devices’ safety by carrying out conformity assessment procedures and eventually issue conformity certificates. Medical devices of classes Is, Im, Ir, IIa, IIb, and III must be subject to a conformity assessment procedure by a notified body. Notified bodies shall conduct surveillance on site audit at least on an annual basis as well as unannounced audit of manufacturer and where applicable subcontractors and suppliers.
The European Commission website NANDO includes a list of accredited notified bodies under the EU legislation. Only accredited notified bodies can issue the necessary certificates that devices need to access the EU market.
As of May 2021, importers and distributors of medical devices have the legal obligation to ensure that their devices on the EU market comply with the MDR.
As of May 2021, as an importer or distributor of medical devices, you have the legal obligation to ensure that the devices you are making available on the EU market comply with the MDR.
By importing or distributing medical devices from manufacturers based outside the European Union, you must add your company details, review and store labels, instructions for use, CE Certificate, declaration of conformity, UDI codes, keep a register of complaints, of non-conforming devices and of recalls and withdrawals and more.
As Authorized Representative for the manufacturer, Obelis will:
- Conduct a full regulatory review of the manufacturer quality management system and technical documentation of his medical devices.
- Provide a vigilance contact point.
- Store the product technical documentation for over 10 to 15 years.
- Verify EUDAMED device registration.
- Validate the manufacturer’s registrations on the EUDAMED portal.