The new Medical Device Regulations, are you ready?

#The new Medical Device Regulations, are you ready?

Are you ready for the new Medical Device Regulations? While writing this, it is almost impossible to respond to this question 100% positive. But all manufacturers will need to review their product portfolios in order to determine if their products are covered by these new legislations and comply, or still comply, with all their requirements.

Discussions between the European Parliament, Council and Commission have taken a long time and resulted in two vast documents, no less than 400 pages each, i.e. the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). The official sign-off and publication of these two Regulations is expected to be Q1 or Q2 2017. And even then, further details in the form of Common Specifications and implementing Directives will need to appear in the coming years.

The combined info of the Proposals of the European Commission for the two Regulations (September 2012), publicized information, and discussions in- and outside Brussels and Strasbourg, show a clear picture of the most critical aspects. Important to know is that the new Regulations have taken a fivefold from the size of the Directives for Medical Devices and IVD-Medical Devices which they are to replace. So, it might be wise to develop a certain tactic if you plan on reading them and you have a specific product in mind. Beneath you find a pragmatic approach on how to assess the status of a product under the new Medical Device Regulation:

  1. Check the scope of the legislation (Article 1, Annex XV);
  2. Compare the manufacturer’s description of the product with the definition of Medical Device (Article 2) and with Annex XV;
  3. Determine the particular roles and responsibilities of the Economic Operators, with some newly defined entities such as the importer and the distributor (with Article 2);
  4. Re-determine the risk classification of the product taking its Mode of Action into account (Article 41, Annex VII);
  5. Select the preferred Conformity Assessment Procedure (Article 42);
  6. Identify the applicable “Essential Requirements” (Article 4, Annex I);
  7. Generate or supplement the Technical Documentation (Annex II);
  8. Apply the applicable Conformity Assessment Procedure (Annex VIII, IX, X or XI);
  9. Complete the Declaration of Conformity (Article 17, Annex III);
  10. Affix the CE Mark (Article 18, Annex IV), now showing compliance to the Regulation.

A “warm welcome” to manufacturers of products without a Medical Purpose

Manufacturers of non-Medical Devices will also have to become familiar with the new legislations because a series of products without a Medical Purpose has been brought into its scope. Although not complying to the general definition of a Medical Device, the application of these products carry many, if not all, aspects of the use of a real Medical Device. Examples of such products are colored contact lenses or other articles intended to be introduced onto or into the eye; substances intended to be used for dermal or mucous membrane filling by injection; equipment for liposuction, all kinds of light emitting laser equipment intended for skin treatment, or cosmetic implants (under Annex XV).

It is expected that their safety will be assessed as if they were classified in line with the best matching classification. Their manufacturers will need to start developing Technical Documentation. Notified Bodies will need to focus on risk separately, as opposed to a risk-benefit ratio where they usually compare residual risks to proven clinical benefits. For presenting compliance to the requirements, Common Specifications will be provided.

Other eye-catching issues

Discussions around these new legislations predominantly focused on improving the organisation of the system, i.e. on stronger supervision and intensified oversight of Notified Bodies by national authority personnel with proven qualifications; more thorough testing and regular checks on manufacturers, including commonly applied Un-announced Factory Inspections; the mandatory implementation of a rotation scheme for Notified Body assessment staff and permanent proven "in house" expertise in the Notified Bodies’ organisation, especially in the field of clinical experience.

Between the many critical elements in the new Regulations, improved device traceability throughout the Supply Chain using UDI systems and the extended registration requirements in the EUDAMED database need to be mentioned. The database focuses on the certificates issued, suspended, withdrawn, refused and restricted by Notified Bodies, on Clinical Investigations, on vigilance data, such as Field Safety Corrective Actions and Field Safety Notices as well as on market surveillance measures taken by Member States. Manufacturer registration and UDI will probably be moved into a separate system.

Significant are the stricter requirements for Clinical Evidence. Clinical evaluation reports are mandatory for all classes of Medical Devices. What changed particularly, are the terms of Clinical Evidence for high-risk devices. The evidence should predominantly be based on data sets with a focus on Clinical Performance Studies covered by detailed described GCP-principles. Class III devices manufacturers will also need to enhance their active and systematic analysis of data on quality, performance and safety using Post-Market Surveillance and Post-Market Clinical Follow Up. They need to report on with Periodic Safety Update Reports, continuously monitoring the Risk/Benefit-Ratio.

Classification and Technical Documentation content of existing products to be re-assessed

Manufacturers should be aware that their current products have to be re-assessed in order to confirm that they still conform to the requirements. Or to determine the gap to be resolved before being allowed to continue marketing their products in Europe. Fortunately, they have three years, or five for IVDs, to perform this re-assessment.

Although they will be able to perform this assessment themselves or with specialized support, a Notified Body is needed for the official confirmation of conformance.

Please note, all Notified Bodies will need to be accredited for these new Regulations before being entitled to assign CE-certificates. To this purpose, the capacity of the joint audit teams of the authority Accreditation Bodies that oversee Notified Bodies has been enlarged. One of the implementing acts prescribes how this should be managed. Probably, Notified Bodies who audit high-risk devices will be able to start relatively early, given the requirements that are being introduced for such products. Having these certifying organisations accredited on time will, most likely, be a challenge for the Accreditation Bodies of the Member States.

In conclusion

Even though the new regulation has not been published yet, and three years for implementation seems far away, it is strongly advised to start your assessment against the new regulations as soon as possible. There are many topics to address and the more time you have available, the easier it is to ensure conformance of your products within the set timeframe. Therefore, do not hesitate and take the ten step approach above, and you will have a quick insight to where you stand with your products.

If you have any questions, feel free to contact us!
Blog by: Louis Habets - Senior Consultant, Xendo

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