Practical guidance for manufacturers of MDs – Hard and Soft Transition periods for CE Certificates of Conformity

The MDR establishes multiple transition timelines for the CE Certificate of Conformity.

These transition timelines were initially intended to enable notified bodies to meet MDR criteria for their (re)certification. The MDR provides stricter criteria for designating notified bodies and set additional requirements and responsibilities for notified bodies and manufacturers compared to the MDD.

Now it is clear that many of the existing notified bodies will lose their accreditation and it will be difficult for new ones to be certified under the MDR. Manufacturers of MDs who obtained certification of their products from British notified bodies may concerned if a no-deal Brexit takes place.

The confirmed list of approved notified bodies will be available in July 2019. As a result, manufacturers should check the date of expiry of their CE certificate and contact their notified bodies ASAP.

Below you will find simple practical guidance, which may help manufacturers to manage the transition to the MDR.

Why it is important?

On 26 May 2017 the Medical Devices Regulation (MDR) entered into force and has been partially applicable. The MDR will be fully applicable as of 26 May 2020. Certificates issued under the MDD after 25 May 2017 and before the MDR fully applies will remain valid for up to four additional years, i.e. until 25 May 2024. Certificates issued by notified bodies in accordance with the MDD prior to 26 May 2017 (e.g. for class IIa) will remain valid until 27 May 2022.

From 26 May 2024 all MDs placed on the EU market must conform to the MDR, though with some exceptions.

Hard and Soft transition timelines

The so called hard transition timeline starts as of 26 May 2020. This means that manufacturers should be ready by Day Zero. This applies to products that have no CE certificate at that date.

The affected MDs are:

• Class I (up-classified),

• Class Ir (reprocessed surgical instruments),

• New Products in scope like those from Annex XVI,

• Custom-made Implantable Class III products (new category) and

• Cases where the manufacturer´s existing certificate expires on or before 26 May 2020.

A hard transition timeline applies if the manufacturer does not manage to renew a certificate by 25 May 2020. The manufacturer will be obliged to proceed under the MDR. The real transition time for manufacturers is then 26 May 2020 – the date as of which the MDR is fully applicable. An open question emerges — is it truly feasible for a manufacturer to certify its MD according to the new MDR prior to 26 May 2020?

On the other hand, a soft transition timeline (four years) enables manufacturers with a valid certificate issued before 26 May 2020 to remain with this certificate until 26 May 2024 at the latest.

Need an example?

Let’s take the example of the soft transition timeline: If the certificate expires on 16 May 2021 for instance, a manufacturer can still sell its products with a CE Mark under the old MDD until that date. So, if the manufacturer can renew its certificate before 25 May 2020, our advice would be not to hesitate but to contact the notified body ASAP. This will then give the manufacturer the opportunity to go until 25 May 2024, which will then be their real transition deadline.

Even if MDs are sold after May 2020 under MDD certificates, manufacturers must follow MDR requirements for PMS, PMCF, registration requirements, and UDI requirements and follow MDD pre-market requirements.

Can manufacturers sell MDs based on expired certificates after May 2024?

Yes. Manufacturers or importers can place their (already produced) MDs on the EU market based on expired certificates, though only until 27 May 2025. After this date, all MDs must be placed on the market based on valid certificates issued by NBs under the MDR. As a result, manufacturers or importers should carefully monitor their stock supplies to see whether they are able to place their products on the EU market by this date.

Conclusion:

Placing a new medical device on the EU market may be problematic even before the MDR is fully applicable. Rules, guidelines or factsheets issued by the EU Commission may be of help to get on track, but there are plenty of issues during the process, which has to be resolved on a case-by-case basis. Whether you seek renewal of your certificate or to place a new product on the EU market or to import MDs from third countries, do not hesitate to contact our local teams at bnt attorneys in CEE.

Подписаться на рассылку

Нажимая «Подписаться», вы соглашаетесь с нашими условиями обработки данных