Is your company ready for EUs new Medical Device regulations?

// insights

In 2017, the EU made the regulatory requirements for Medical device companies stricter by voting to adopt the new legal proposal (1). Already heavily regulated industry is now receiving even more rigorous requirements. The regulatory framework within the EU goes from Directive to Regulation and becomes directly applicable as legislation in all member states. The conditions now also include additional economic operators in the Supply Chain, such as distributors and importers.

Voices within the Medtech industry mean that this is the most significant change in the medical device industry since the 1980s. Others believe that this change will make the EU one of the most challenging markets to access for medical device manufacturers, meaning time to market and costs will increase.

The EU Commission has been working on this proposal for several years. One significant change is that the actual text in the new Regulation has become more extensive; for example, it now includes several areas previously covered in various guidance documents.

On 26 May 2017, two new medical device regulations (2) took effect (Entry into force) in the EU: MDR (Medical device regulation 2017/745) and IVDR (In Vitro Diagnostic Medical Devices Regulation 2017/746). MDR will apply fully from 26 May 2021 (original Date of Application 2020 has been postponed to 2021 due to the Covid-19 pandemic), IVDR apply fully from 26 May 2022.

Details and how everything will work is still in progress, although many guidance documents have been developed during the last year. But guidance, interpretations, and best practice are yet being determined. State of the art is one of the beacons in the new Regulation. Therefore, it is essential to monitor and stay informed continuously. We at Knightec are closely following the development and how the regulations are being interpreted and applied by the Commission, Notified Bodies, and the Swedish MPA (Medicinal Products Agency) Läkemedelsverket.

Major changes

Companies within the Medtech industry needs to plan how to work with the new Regulations, both for the transition and future continuous compliance. Below is a list, with comments, of some of the changes and what it means- some already apply:

  • Expanded definition of medical devices and accessories, now also including some “products without an intended medical purpose”, e.g. contact lenses (not visual correction) and substances for facial or other dermal fillings. (MDR chapter l, Articles 1-2). The latter is required by so-called Common Specifications that the Commission will develop.
  • On the IVD side, many more IVD products will be covered by the IVDR than the current Directive.
  • Changed classifications rules, e.g. for software as medical devices, nanomaterials, and a new class I for reusable surgical instruments. (MDR Chapter V, Annex VIII)
  • Clearer requirements for manufacturers Quality Management system and Risk management process. (Chapter II, Article 10). Here it is recommended to use EN ISO 13485:2016 for the Quality management system, and the updated EN ISO 14971:2020 for Risk management processes for medical devices. (3)
  • Clearer and increased requirements for the content of the product’s Technical documentation (Annex II and II), the documented evidence on safety and performance following regulations and applicable standards. Today’s Essential requirements in the Directive has been replaced by safety and performance requirements (MDR Annex I). The checklist (now required) needs to be updated concerning for example updated processes and procedures, standards (latest version is state of the art as long as no standards have been harmonized for MDR) for each product/product group. All relevant standards will be updated to match MDR requirements in the coming years, but harmonization has not yet started.
  • Expanding and strengthening clinical evidence requirements: The possibility to, for example, use “equivalence” to similar products in clinical data is now limited if access to the complete technical documentation for a similar product is missing. Many manufacturers have started their work on MDR transition by performing so-called post-market clinical follow-up studies for their CE-marked products. In this way, they will have access to their clinical data to base the Clinical evaluation for MDR on.
  • Increased requirement on active continuous surveillance of products on the market, Post Market Surveillance. The outcome shall be summarized in reports and feed into risk management, clinical evaluation, CAPA, etc. as applicable.
  • Different forms of review mechanisms are introduced for higher risk classes and certain types of products. This affects the time to market because, for some products, the authority must review the documentation and their response time for 150-210 days. This has to be taken into consideration in developing project schedules.
  • Introduction of a European database, EUDAMED. Here, among other things, manufacturers register products, report serious incidents, and field safety corrective actions, as well as continuously (for higher risk classes) report safety information. The database information will be partly public, but with full access and exchange of information between EUs National Competent Authorities. The database will impose an increased administrative burden on legal manufacturers.
  • Step by step introduction of UDI (Unique Device Identification, based on risk class, which is a code with which every medical device must be assigned (and labelled with if reusable device). UDI also needs to be included in the technical documentation. A technical solution (barcode or QR code) is not selected yet. Introduction of labelling for class III and implants is scheduled to 2021. The other risk classes will follow in the coming years. This poses a major challenge logistically and practically for many manufacturers, especially if you don’t have an established UDI on, for example, the US market.

Is there a transitional period or does this apply directly?

The new regulations require a completely new certification for all medical devices and manufacturers. During a period, until May 2024 at the longest for MDR, medical devices CE-marked under the current Directive can be put on the market (soft transition). However, depending on the risk class of the product and valid directive certificates, all medical devices will have to comply with MDR or IVDR sooner or later to continue being put on the market. Market access and CE-marking can take place after a new conformity assessment.

Start in time!

To start now, if not done already, it is a must. There are many transitional details, and already amended rules, for manufacturers in the regulatory framework to take into account and plan for strategically. For example:

  • Product portfolio review: which products should be transferred to MDR? The status of existing documentation can be crucial in deciding the business case.
  • GAP analysis of quality management system processes and procedures, Technical documentation, and inventory classification rules.
  • Using the “soft transition”, continue to put medical devices on the market based on the directive certificate, which means no significant changes on the product after May 2021. Does this fit into innovation strategies, market plans, and customer expectations?
  • Ensuring competence: training of co-workers and assuring the availability of external experts to the company. MDR requires a Person responsible for regulatory compliance to be employed or to be affiliated with the company, depending on the size of the company.
  • Ensure access to appropriate Notified Body (NB): As an increased amount of manufacturers will need a so-called Notified Body, for review of the quality management system and assessment of the Technical documentation, NBs will be fully occupied. Right now, many NBs are busy in designation for MDR/IVDR. In recent years, the number of NBs has decreased significantly, and the pressure on those who remain is increasing.

Knightec can help manufacturers to strategically plan how to and assist in performing the work to meet the new requirements in the best possible way. We have a long experience of making investigations, GAP analysis as well as creating or updating technical documentation, quality management systems, etc. within the Medtech industry. Contact us to find out more.

Author

Ankie Karlsson is a Senior Advisor within Quality & Management at Knightec. She has many years of experience in Quality Assurance and Regulatory Affairs for medical devices. Today Ankie works as an advisor, expert, and trainer as a leader of Knightec’s specialization Medtech Compliance. Ankie is an expert developer for medical device standards in the Technical committee TK355 at SiS, Swedish Standards Institute, and chairperson of the same committee since January 2020.

References:

  1. The EU Commission's website, The new regulations on medical devices,
    https://ec.europa.eu/health/md_newregulations/overview
  2. The Swedish MPA (Medical Products Agency, Läkemedelsverket, website,
    https://www.lakemedelsverket.se/sv/medicinteknik/tillverka/regelverk
  3. EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016). EN ISO 14971:2020, Medical devices — Application of risk management to medical devices (ISO 14971:2019)
    https://www.sis.se/standarder

Related posts

The value of clients in teams

Traditionally, consultants work for the client adding value with their expertise and the time they put into the assignment. Today the projects that our consultants and engineers take on, don’t work like that. Now a holistic approach, the ability to cooperate, working towards the same goals, and integrating the client in the process is what matters the most.

Read more
// Data Driven
// Electrified

Meet Jonas, who automates with machine vision

Jonas Stenvall is one of Knightec's experienced consultants working with machine vision. He is passionate about automating work processes, and in his projects, he works primarily with software development.

Read more