New requirements on Medtech-products

Is your company ready for the EU’s new regulatory framework for medical devices?

Last year, the EU tightened the regulations on medical technology companies. An already highly regulated industry is now getting greater demands from 2020. The EU regulatory framework goes from directives to regulations and becomes directly applicable affecting legislation in all member states. The requirements now include more players as distributors and importers.

Some within the Medtech industry believe that this is the largest change for Medtech in the EU since the 1980s. Others believe that this change will make the EU one of the more difficult markets for access for medtech manufacturers.

“On May 26, 2017, two new medical device regulations came into force in the EU: MDR (Medical Device Regulation 2017/745) and IVDR (In Vitro Diagnostic Medical Devices Regulation 2017/746) 1). MDR shall apply from May 26, 2020, IVDR from May 26,2022.”

All details for how this will work in the future are not yet fully established. Therefore, it is important to follow the development and remain informed on a regular basis. Knightec is following the developments closely and keeping up to date with how the rules are applied via the Swedish Medical Agency.

Major changes are under way

Medtech companies need to plan how to work with the regulatory changes. E.g.Listed below are major changes along with comments on what it may mean:

  • Extended definition of a medical device and accessories, as well as the partial inclusion of certain “non-medical” products, such as contact lenses without strength or substances to fill the skin. (MDR Chapter I, Article 1-2). The latter are claimed by so-called common specifications that the Commission will provide. On the IVD side, many more IVD products will be covered by IVDR than today.
  • Changed classification rules, including for software such as medical devices and nanomaterials, as well as a new class I introduced for reusable surgical instruments. (MDR Chapter V, Annex VIII)
  • Clearer demands on manufacturer’s quality system and risk management process. (Chapter II, Article 10). Here it is advisable to use EN ISO 13485: 2016 as a basis for its quality management system and EN ISO 14971: 2012 for its risk management process for products.3)
  • Clearer and increased requirements for the content of the product’s technical documentation (Annexes II and II), the proof that safety and performance are achieved according to regulations and applicable standards. Today’s essential requirements are replaced with requirements for safety and performance (MDR Annex I), this list needs updating with reference to e.g. harmonized standards for each product/product family as of today. All harmonized standards will need to be updated against MDR in the coming years.
  • Extensive and reinforced clinical evidence requirements, where the possibility pointing to equivalence to similar products in clinical data limited, if access to complete technology documentation for that product is missing. Many manufacturers that started their work with MDR now initiate so-called post-market clinical follow-up studies for its CE-labeled products. This is in order to have its own clinical data to base its clinical evaluation on for MDR.
  • Increased requirements for active market surveillance (Post Market Surveillance).
  • Various types of review mechanisms are introduced for higher risk classes and certain types of products. This affects time to market because for some products, authority should review the basis on their response time, which can be between 150-210 days. This will be included in schedules for development projects.
  • Introduction of a European database, EUDAMED. Here, among other things, manufacturers register products, report accidents and incidents, as well as ongoing (for higher risk classes) report safety information. The database’s information will be partly public, but with full access and information exchange between supervisory authorities in the EU. The database will entail an increased administrative burden on responsible manufacturers.
  • Introduction by Unique Device Identification (UDI); a code that each medical device should be labeled with and, inter alia, shall also be included in the technical product documentation. Technical solution, e.g.barcode or QR code, is not selected yet. Introduction to labeling at the earliest 2021 for Class III and Implants. Other risk classes will follow next year. This poses a big challenge logistically and practically for many manufacturers, especially if you are not already in favor of UDI ex. for the US market.

Will it be applied directly?

Many talk about a “transitional period”, but the new regulations really mean brand new certification for all medical devices and manufacturers. For a period, as long as up to May 2025 for MDR, medical devices’ CE marking under today’s directives will be put on the market. However, depending on the risk class on the product and current certificate, all medical devices will need to meet MDR or IVDR in order to continue to be placed on the market. Market access and CE marking may be subject to a new conformity assessment.

Start the work early

Starting now is a must. There are many details about transition in the regulatory framework for manufacturers to take into account and make a strategy. For example:

  • Product portfolio review: what products should be transferred to MDR? Decisive may be the status of existing documentation.
  • GAP analysis of quality system, product documentation and inventory classification rules.
  • Ensure competence: educate employees and associate experts about the business. MDR requires a regulatory expert person to be employed, or linked to the company in case of smaller companies.
  • Ensure access to the appropriate Notified Body: Many more manufacturers will need to interfere with Notified Bodies, NB:s, for Quality System Review and/or Technical Product Documentation. Right now, they apply for NB:s That wish for appointment (designation) against MDR / IVDR. In recent years, the number of NBs has decreased sharply and the pressure on the remaining ones is increasing.

Knightec can support manufacturers in work with strategic plans and who to best meet the new requirements. We have extensive experience of doing investigations and GAP analyses to create/update technical product documentation, create/update quality management systems, etc. within Medtech. Knightec´s Compliance Optimized business focuses around this.

Contributor

Ankie Karlsson is a Quality & Management Advisor at Knightec. She has many years of experience in quality management and regulatory issues in medical technology. Today, Ankie works as an advisor, expert and educator for Knightec’s medical technology team and customers.

References:

  1. EU kommissionens websida, The new regulations on medical devices,
    https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en
  2. Läkemedelsverkets websida, Medicintekniska produkter enligt ny lagstiftning från 2017,
    https://lakemedelsverket.se/malgrupp/Foretag/Medicinteknik—ny-lagstiftning/
  3. EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016). EN ISO 14971:2012, Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)