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Medical Devices Regulation 2017/745

08.03.2019

Due to COVID-19 the implementation date of Medical Devices Regulation 2017/745 has been postponed until 26 May 2021.

The new Medical Devices Regulation (MDR) came into effect on 25 May 2017. As of 26 May 2020 (due to COVID-19 as of 26 May 2021) MDR will replace:

  • the current Medical Devices Directive 93/42/EC (MDD), and
  • the current Directive for Active Implantable Medical Devices 90/385/EC (AIMDD).

During the transitional period in the past three years, the manufacturers and authorities have been able to make preparations for the new rules. MDR is aimed at:

  • increasing patient safety in Europe by subjecting manufacturers of medical devices in all the EU Member States to equal product safety requirements, and
  • ensuring the supply of innovative medical devices to patients.

MDR will bring about major changes. Moreover, MDR will also be applicable to products that have already been placed on the market. Therefore, it will be important for manufacturers, importers and distributors of medical devices to make timely preparations for these changes. This article will provide you with the necessary steps.

Medical Devices Regulation 2017/745 and national legislation

The MDR applies directly to all the Member States of the European Union. This means that the Member States are not required to transpose these rules into their own national laws. There are, however, a number of aspects, such as the post-market surveillance system and its regulatory enforcement that must be coordinated by the national authorities. Furthermore, MDR offers the EU governments enough space to make their own policy decisions on certain subjects, e.g., on the reprocessing of single-use devices. The decisions taken by The Netherlands will be laid down in a new version of the Dutch Medical Devices Decree that is currently under preparation. The new decree will replace the current Dutch Medical Devices Decree. The Ministerial Regulation Medicines Act will also be replaced.

Significant changes as a result of MDR

Compared to MDD, the most important changes contained in MDR are:

  • MDR has a broader product scope than MDD. MDR also covers devices for esthetic purposes, such as coloured contact lenses, wrinkle fillers for cosmetic use and equipment for liposuction. The product groups that fall within the scope of MDR are defined in Annex XVI of MDR.
  • More products will be classified in higher risk classes. In case a product is classified in a higher risk category than risk class I, it will be mandatory to assign a Notified Body to determine whether the product complies with the relevant requirements. The new classification rules are defined in Annex VIII of MDR.
  • The national authorities of the Member States will enforce a higher level of monitoring Notified Bodies. Moreover, first of all the Notified Bodies must be re-designated. This means that a conformity assessment for your product can only be carried out within the scope of the new rules, after the Notified Body has been designated by a Member State.
  • Compared to manufacturers, Notified Bodies will be granted more authorisations, e.g., they will be able to perform unannounced on site audits.
  • Within the scope of MDR, products must comply with stricter requirements. More extensive clinical data will be needed in order to obtain market access.
  • An extensive European electronic database on medical devices will be created: Eudamed. This database will process a substantial amount of public data concerning products on the EU market. Both healthcare professionals and patients will receive access to Eudamed.
  • Healthcare professionals will supply a so called “implant card” to patients with an implanted device, after implanting such device. This card will contain information on the implanted device and the manufacturer of the implanted device.

The steps manufacturers need to take for the MDR implementation

Considering the amount of tasks that need to be fulfilled, there is not much time left till 26 May 2021. That is the reason why it is important for you to:

  • get a fast and thorough insight into both the MDR rules and the effect of the MDR changes on your product, compared with the current Directive;
  • Conduct a MDD/MDR GAP analysis in order to assess your products within the scope of MDR. Please take note of the broader definition of a medical device and the reclassification of product groups;
  • if necessary, designate a Notified Body;
  • collect (additional) clinical data, if necessary. Clinical research must establish the safety and performance of the device. The higher the risk class of the product, the higher the standards for clinical data will be;
  • if necessary, carry out a new conformity assessment procedure (for CE marking). Without a CE marking you are not allowed to place your products on the EEA market.
  • assign a Person Responsible for Regulatory Compliance (PRRC). This is defined in article 15 in MDR.
  • comply with the remaining requirements of MDR in due time. It will be necessary for you to file a timely request for a registration number (SRN) in Eudamed. You will need an SRN when applying to a Notified Body for a conformity assessment. As of 2021 it will also be mandatory for you to affix a Unique Device Identifier (a code generated by the Unique Device Identification system) to your products. This will enable traceability in case of an unexpected shortage.

The steps importers and distributors need to take for the MDR implementation

Importers and distributors will also have to comply with stricter requirements within the scope of the MDR.

Importers must register with Eudamed and:

  • verify that the CE marking and the UDI-code have been affixed to their product;
  • verify that the instruction for use is included with the product;
  • verify that the manufacturer is registered in Eudamed and/or has assigned an Authorised Representative who is also registered in Eudamed;
  • verify that the medical device complies with all the relevant requirements;
  • keep a list of complaints or reports on devices and forward these to the manufacturer;
  • inform the competent authorities, in case of suspected non-conformity of a device.

Distributors must:

  • verify that the CE marking and the UDI-code have been affixed to the product;
  • verify that the instruction for use is included with the product;
  • verify that the EU Declaration of Conformity has been drafted;
  • verify that the importer complies with the relevant requirements;
  • keep a list of complaints or reports on devices and forward these to the manufacturer;
  • inform the competent authorities , in case of suspected non-conformity of a device.

Who will be in charge of post-market surveillance and regulatory enforcement under MDR?

Although MDR applies directly to all EU Member States, the national authorities of each EU Member State will be responsible for the post-market surveillance and regulatory enforcement. In The Netherlands The Dutch Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd or IGJ) will be responsible for regulatory enforcement within the scope of MDR. The IGJ will monitor, e.g.:

  • manufacturers, Authorised Representatives, importers and distributors who are operating in The Netherlands;
  • Notified Bodies who operate in The Netherlands,
  • reports on incidents and corrective actions in The Netherlands.

The Inspectorate’s qualifications will be defined in the new Dutch Medical Devices Decree, which is currently under preparation.

Transitional period after 26 May 2021

As you may have come to understand, the new rules will also apply to products that are already on the market. For specific devices there will be a transitional period during which the products that are already on the market, may be traded.

What can we do for you?

Please take note that your products may now fall in a product group that is covered by MDR, or in a higher risk class. Considering this, you will need a great deal of time to take all the necessary steps to prepare yourself for the implementation of MDR. Collecting (additional) clinical data or assigning a Notified Body are very time-consuming tasks, but our regulatory experts at Certification Company will assist you with great pleasure!

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