Recent European Developments

EU Medical Devices Regulation

The current Medical Device Directive (MDD) is on the brink of being replaced with the new Medical Devices Regulation (MDR) and the expected changes are extensive. The MDR is in the final stages of the legislative procedure and is expected to be released late 2016 or early 2017.

Product Classification:

A significant number of definitions will change, including those of medical devices themselves. Many products not currently classified as medical devices under MDD will become medical devices under MDR, such as:

  • Devices that specifically assist another device in its intended operation;
  • Products based on human cell or tissue derivatives; and,
  • Some non-medical devices that have a similar risk profile to medical devices.

Other classification rules will change for certain devices as well, which will require some devices currently on the market to be recertified, typically in a higher risk class.

Regulatory Responsibility:

Another new addition to the MDR is the obligation to have a person responsible for regulatory compliance available within the organization. The MDR does not explicitly require that the person be an employee, recognizing that medical device companies often use consultants in this role.

Product Documentation:

The technical file will have a new, mandatory structure and content. Most technical files will need to be revised and additional clinical evidence generated. The MDR also requires a full technical file be present at each manufacturer. Manufacturers will now have to either share their technical files with Own Brand Labelers (OBLs) who buy a product made by the manufacturer, or OBLs will have to build their own technical files.

The clinical requirements are changing as well. Compliance with the current MEDDEVs on clinical requirements is unlikely to be sufficient for compliance to the new rules. Manufacturers will need to revise clinical strategies for new and current devices. In addition, Post-Market Surveillance will need to be brought into a continuous evaluation and improvement loop that includes a continuous review of risk management, an annual public summary of safety and performance, and clinical evaluation compliant to the new regulations.

Notified Bodies:

A particularly large change in the MDR for the industry revolves around notified body supervision. All notified bodies will need to apply for a new designation. According the BSI, a leading notified body, it is expected that 50% of notified bodies may not be re-notified or may not be notified for the same scope under the new regulation. Manufacturers will need to contact their notified body to verify that they are still suitable for their products.

Insurance for ARs:

There are two hotly debated items that may or may not be included in the new MDR. The first is the possibility that manufacturers and Authorized Representatives (ARs) will be required to have product liability insurance. If this is included, it is expected that many ARs will cease activities. The second hotly debated item is proposed requirements for reprocessing single use devices. It is difficult to predict whether or not these will be part of the MDR at this time.

Common Specifications:

The MDR also references future guidances, known as Common Specifications (CS). Over the next few years, groups of experts will write a growing number of these Common Specifications to fill gaps where no harmonized standards exist or where relevant harmonized standards are not sufficient. We wish they would use the term “Requirement” rather than “Specification”!

Timeframe:

The transitional regime is not yet fixed. The transitional period duration, typically 3 years, may or may not be extended. It has not been decided when CE certificates issued under the current directives will expire. Once the transitional regime is announced, it will be particularly important to have a plan in place during the transition. Generating new required data, amending the Declaration of Conformity, and updating the technical files will take time.

AlvaMed will stay on top of these developments and ensure our customers are informed as soon as the final decisions are made.

MEDDEV 2.7/1 Revision 4

After much anticipation, the updated version of MEDDEV 2.7/1 (revision 4) entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and 90/385/EEC with updated guidance on clinical evaluation was released on June 29, 2016.

The medical device industry in Europe is facing extensive change as this MEDDEV 2.7/1 update coincides with the new MDR directive. AlvaMed sees these changes as positive and necessary as technology and the medical device industry continue to grow in Europe. But what does the updated guidance on Clinical Evaluation Reports (CERs) mean for your company? What changes should you expect?

The latest version of the MEDDEV 2.7/1 is the new standard against which notified bodies and health authorities review clinical evaluation reports prepared by medical devices manufacturers. This updated version of MEDDEV 2.7/1 is more detailed and includes expansive requirements for risk management, clinical data and post-market surveillance. There is no implementation period for the MEDDEV since it is a guidance document, therefore it is important to start using the new version as soon as possible.

The premise of the updated version of the MEDDEV 2.7/1 is similar to the December 2009 version. Medical device manufacturers use clinical data to demonstrate compliance with relevant Essential Requirements. The clinical data still needs to be collected and analyzed, but in the updated version the level of detail of how this should be completed, what are the applicable methods that should be used and when this should be done are almost completely new and more detailed.

As per the updated MEDDEV 2.7/1, data is inputted into clinical evaluations through all stages of the medical device lifecycle including the design stage. Moreover, clinical evaluations are more detailed in their scope and who should be performing them. Furthermore, the updated version of the MEDDEV requires manufacturers to be transparent about methods used and the steps taken in the analysis of clinical data.

To learn more information on MEDDEV 2.7/1 revision 4 please use the following link to read the published update: MEDDEV 2.7/1 Revision 4