We see a steady stream of regulations and directives from EU strengthening regulatory demands on several markets. Now it’s time for the medical technology market to receive stricter demands trough Medical Device Regulation (”MDR”) replacing the current legislation. With MDR comes stricter requirements in several areas. In this article we will cast a light on some of the most important changes.
Background
On 5 April 2017 the European Parliament decided to adopt two new regulations on medical devices: MDR (Medical Device Regulation 2017/745) and IVDR (In Vitro Diagnostic Medical Devices Regulation 2017/746). These two regulations replace the current EU directives and the Swedish law on medical devices. MDR will apply as European law from 26 May 2020. The regulation will also replace the Swedish Medical Products Agencies regulations (LVFS 2003:11) and (LVFS 2001:5). Further adaptation of Swedish legislation in related areas will be necessary to harmonise the new regulatory framework.
The aim of the new regulation is to create a strong, transparent, sustainable and internationally recognised framework with improved clinical safety and access to the market on equal terms for manufactures. As the same legislation does now apply to all EU Member States, a more unified market is created for medical devices that are sold within the EU. The regulation is also meant to handle the fast technological and scientific development in the field.
What happens now and what has changed?
The new legislation enters into effect on 26 May 2020, that is to say in almost exactly one year. During the coming year all companies in the medical technology field will need to evaluate and make an inventory of their business and their products and implement necessary adaptations to meet the new requirements. Some businesses are facing great changes and if the work to bring them about has not yet begun now is urgent to get started.
The general requirements placed on manufacturers and products are largely the same in MDR as in the previous EU directives. This is because no current requirements have been removed, only new requirements have been added on. Below is a summary of the ten most important changes:
1) The definition of what constitutes a medical device is expanded. Some products without medicinal purpose that are similar to medical devices when it comes to function and risk profile will be included. Examples of such products are skin filling substances and contact lenses without lens power. Also, when it comes to IVD products a number of new IVD products will be included in IVDR than what is currently the case. MDR also includes the sale of medical devices online and services provided from a distance.
2) The rules of classification are changed. Among others a definition of nanomaterials has been introduced and software as a medical device has been specified and clarified in the new regulations. A new class I has been introduced for recyclable surgical instruments. Some products that have previously been in a lower risk class have been moved up to higher risk classes, which leads to increased requirements for the manufactures.
3) More stringent requirements on the manufacturers’ quality systems, risk-management processes and follow up. The manufacturers will, in some cases, be obligated to publish safety reports (Periodic Safety Update Reports), designed to give the users and healthcare providers current information about the medical devices that they use for improved patient safety. This meets the need for a transparent exchange of information between healthcare providers, users and manufacturers. There is also increased requirements on active surveillance of products on the market (Post Market Surveillance) and ensuring that the manufacturers systems cover the liability for damages caused by defective products.
4) Requirements of a specialist within the field of medical devices. The manufacturer must have a specialist within the field of medical devices who is responsible for compliance with the regulatory framework within the organisation. The expertise must be verifiable. This requirement does however not apply to companies with less than 50 employees. These companies are instead required to have access to such a specialist.
5) More transparent and increased requirements on the content of the product’s technical documentation and clinical evidence. Manufacturers must produce a clinical evaluation report as part of the technical documentation. The possibility to refer to equivalence with similar products in clinical data is limited through MDR. This means that manufacturers may be obligated to supplement their technical documentation with their own technical data to meet the requirements for their CE-marked products.
6) More transparent requirements on reports on substances is introduced. Manufacturers of some products, as for example implants, are obligated to report which substances that are part of the product which aims towards strengthening the protection for patients with hypersensitivity problems.
7) Requirements on implant cards are introduced. All patients that receive an implant must also get an “implant card” to take with them home. On this card you can read exactly which implant, with full traceability, that the patient carries inside.
8) The European database, EUDAMED, is introduced. Here the manufacturers, among others, register products, report accidents and incidents as well as (for the higher risk classes) continuous reporting of safety information. The information in the database will partly be accessible to the public, but it will be fully accessible to supervisory authorities within the EU. The database will mean an increased administrative burden on, among other, responsible legal manufacturers.
9) All medical devices will be marked with a ”Unique Device Identifier, UDI”. The UDI code will make it possible to always be able to trace the manufacturer and get full information regarding the product. The implementation of the marking requirements and system will be made gradually.
10) Additional review mechanisms are introduced, and more products becomes subjects for review by a Notified Body. Some class I products shall from 26 May 2020 be reviewed by a Notified Body before they are released onto the market. The Notified Bodies (in Sweden) must also be approved by the Swedish Medical Products Agency and current Notified Bodies must get a new approval that confirms that they are compliant with the requirements in MDR. To appoint a notified body can take up to 12 months or more and presently there are still no approved Notified Body for MDR in Sweden. Probably, the first Notified Bodies will be approved during the spring of 2019.
As a consequence of the increased number of products that are now subject to review combined with the fact that the Notified Bodies also need to adapt their operations to MDR, the workload of and the pressure on the Notified Bodies will be huge. It is therefore important to contact a Notified Body as soon as possible to get a certificate in time before the regulation takes effect 26 May 2020. It is the legal manufacturer that must verify that the Notified Body is appointed in accordance with the regulation whether it is authorised to handle all of the manufacturer’s products or not.
The review requirements will affect the ”time to market” for new the products and together with the heavy workload of the Notified Bodies we are in danger of seeing the lead time significantly prolonged before new products are released onto the market. These time aspects must also be taken into account when planning new product development projects.
How do we prepare?
If you as legal manufacturers of medical devices have not yet started to prepare for the adaptation to MDR now is the time to do so! We recommend that you make a situation assessment and a prospective analysis of your business. As an example, you can start with the following questions:
1) Do you have products that presently falls outside of the scope of the regulation, such as beauty products or contacts without lens power, that will now be included?
2) Will your products, or some of them, need reclassification and which classes may be applicable in that case? What consequences will reclassification have for your business?
3) Does any part of the technical documentation need to be supplemented with a clinical evaluation of your own? Clinical evaluations are very time consuming to complete and such work must be commenced immediately.
4) Does your quality and operational systems perform in a satisfying manner in regards to risk class and business? A suitable way to ensure a well-functioning system is to implement the ISO standard 13485:2016. Please note that the standard was updated in February 2019.
5) Do you need to employ a specialist?
6) Do you need to update your product information, introduce implant cards or report special substances?
7) Will the products need to be reviewed by a Notified Body or is any other registration or approval required?
8) Consider if manufacture and distribution channels needs to be looked over, partly to ascertain correct responsibility at all levels and partly to ascertain that you as manufacturer receives all the information you need to meet the requirements for Periodic Safety Update Reports and Post Market Surveillance.
Siri Mårtensson
Advokat, Senior Associate
Tel: 070 160 39 53
E-post: siri.martensson@morrislaw.se
