Medical devices marketed in the European Union are required to comply with a set of medical device directives called the “medical devices regulation” or MDR for their Conformité Européenne (CE) marking and marketing in Europe. Over the past decades, the body of MDRs in Europe has grown to include several documents that medical device manufacturers know well (Directives 2001/83/EC, 90/79/EC, and 93/42/EEC; Regulations (EC) numbers 178/2002 and 1223/2009).
On May 25th, 2017 the European Union entered into a new set of MDRs (Regulation (EU) 2017/745) which consolidate and replace the medical device directives and regulations that manufacturers and reporting bodies are accustomed to. The new MDRs become enforceable May 2022 allowing for a 3-year transition period up to May 2025, after which all devices, new or existing, must comply with the MDRs. For devices already having CE marking, this means that when their CE marking meets its expiration date they must be resubmitted under the new MDRs during the 3-year transition. By May 2025 only medical devices conforming to the new MDRs will be allowed for market in Europe.
What do the new MDRs mean for you?
Regulation (EU) 2017/745 is an extensive and detailed document encompassing many important rules that will be new to medical device manufacturers in the European market. A couple of these new rules are especially relevant to manufacturers with an extensive catalog of devices long on the European market.
- There is no “grandfathering” provision; all currently approved devices on May 2020 will have three years to be re-certified under the new rules.
- There is an expanded definition of what is considered a medical device; many devices which previously did not require certification (for example diagnostic and aesthetic devices) will now require certification.
- Requirement of a “Qualified Person” who is Responsible for Compliance; each manufacturer must have at least one expert who is qualified to ensure that devices are compliant with the new regulations.
What the three points above mean for manufacturers is that regardless of how long your device has been on the market, devices will need to be reevaluated by an expert and submitted to a Notified Body for recertification. Many devices that never needed certification before will require evaluations on or before May 2020.
For many manufacturers, these new regulations require them to reevaluate their entire product catalog for compliance. Critical decisions must be made regarding the cost and time of recertification and the value of having niche devices on the market.
How can Nelson Labs Help You Comply with Regulation (EU) 2017/745?
Nelson Labs has a team of experts and a process available to help manufacturers bring their device catalog into compliance with the new MDRs. The details of the evaluation process depend on the spectrum of devices being evaluated, but generally evaluation follows these steps:
- A Nelson Labs Biocompatibility Expert examines the product catalog, and in collaboration with the manufacturer prioritizes which devices should be evaluated first.
- On a case-by-case basis, information on individual devices in the catalog are reviewed and grouped into product families.
- An MDR Gap Evaluation is performed on the medical device family. The result of the evaluation is a written document that contains the following:
- Identification of members of the device family
- Justification for the family grouping
- Review of relevant existing material and biocompatibility data
- Recommendations on testing for further evaluation needed to bring the family into compliance
- Further evaluations, chemistry testing with assessment, and a limited set of biological tests are performed to bridge any biocompatibility gaps.
- If all the testing is positive, a biological evaluation report is written which summarizes the device family, the results of testing, and states that the device is in compliance.
Partner with an Expert
It is important to partner with an expert to develop thorough evaluation plans upfront to mitigate excessive testing costs, unnecessary testing time, and wasted test samples. Even then, strategies that heavily involve animal testing are likely to be the most expensive and time consuming, while strategies that utilize a risk-based approach minimize the need for new testing – which save the manufacturer both cost and time.