Transition from MDD to MDR 2017/745 with ease thanks to Pepgra
Pepgra experts answer key questions pertaining to the transition from MDD to MDR. Here is their take on this topic
1. When should we phase to the MDR because we just renewed the MDD certificate?
- Maximum validity of five years for MED certificates issued before the final implementation of the MR. (around second quarter of2020); however, all MED certifications will automatically be invalid four years after the new regulation comes into play. Wait until 2023 (for MED Annexure IV certificates) or 2024 to renew under the MDR, but this comes with uncertainties that could leave you with an expired certificate.
2. Should we re-certify under the MDR because our CE Marking certificate is going to expire?
This is a certainly a complex topic that hinges on
- existing designation status of your notified body (NB);
- actual date of expiry of your certificate;
- completeness of your internal resources; and finally,
- completeness of your clinical data.
The big question mark is the sequence in which notified bodies will be designated for the MDR and when this will start; therefore, you must have clarity on this topic to answer the above question with assurance.
3. When do we have to transition to the MDR?
- Class I devices must not be available on the market from the day of application of the MDR. Stocks already placed on the market can be sold out; in addition, there is no allowance or grace time for your devices; hence, Pepgra experts recommend going for on-time transition as you may encounter certain bottlenecks in NB capacity around 2020.
4. How do we find a new one if our NB (NB) indicates that they plan to exit the medical device business?
- To add on to existing heavy work assignments, the number of NBs operating in EU is dwindling and those that are in operation must define the scope. Pepgra can assist with NB evaluation if you find yourself without an NB during the transition phase.
5. Is it still possible to certify under the MDD if we are manufacturing a new device because we have a family of Class I, self-certified devices that will fall in Class IIa under the MDR?
- New MDD certificates can be fleshed out till the date of MDR application; after that, all new certificates will be issued under the MDR. The type of certification you select will mainly depend on when you want to introduce your device on the market. If you are early, there may not be a designated NB available. In that situation, you have go for MDD certification. If you are very late entrant then your device may enter the market after second quarter of 2020 when only MDR certificates are given. If you are somewhere in the middle, you may to choose between either strategy. This also hinges on what your NB will accept for your device.
Schedule of new regulations
- April 5, 2017: The EU Medical Device Regulation was adopted.
- May 5, 2017: The Regulation was published in the Official Journal of the EU.
- May 26, 2017: The Regulation entered into force and will apply in parallel with the current medical devices directive MDD 93/42/EEC for a transition period of three years.
- December, 2017: The process of re-designating EU Notified Bodies under the new regulation begins. The first designations are expected to be finalized some 12 to 18 months from the date of publication of the legislation.
- May 25, 2020: The transition period ends and the MDR becomes compulsory.
How does Pepgra help you in making the transition?
There is a lot of work to do considering the short duration of 3 years. Device makers need to start preparing now to make sure their products are compliant by May 25, 2020. Pepgra leads the way forward.
- a) Ensure you have exhaustive knowledge of the new legislation and the changes from the current MDD.
- b) Perform thorough gap reviews to review your current products against the new legislation. The gap assessments should also take into account the reclassification of certain product groups as well as MDR’s broader definition of a medical device.
- c) Note that the management system standard for medical device manufacturers – ISO 13485 – has also been upgraded. The last date for transitioning to the new edition (ISO 13485:2016) is February 28, 2019.
Get insights on MDD and MDR regulations; talk to Pepgra CRO experts today
Pepgra is a leading CRO solutions for medical device manufacturers with offices across US, UK and India. Pepgra CRO experts offer assistance in all phases of clinical trials. Clinical research, regulatory affairs, regulatory writing, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, and Post-marketing Surveillance (PMS)—these are some of our offerings with niche therapeutic offerings as a key differentiating factor. Partner with Pepgra today; your reliable CRO partner. www.pepgra.com | +1-972-502-9262 | sales@pepgra.com
