MDR impact at international registration of medical device

MDR is European`s binding bible of medical device which is still in sensitive discussion. Hospitals complain about shortage of some MDD products. Manufacturers are still in labyrinth to find solution of core MDR. Notified body is careful to make any supporting article to leverage review of technical documentation although Team NB makes some position paper. EU is far away from revision and simplification of current implementation of certification of MDR.

We will make some transparent series of impact of MDR at international registration and learning from Chinese and American authority dedicated to all stakeholders in EU market.

We wish a better trend useful for health system and maybe risk based move relieving low class products and innovative products.

The fact of MDR certification is that many manufacturer give up some MDD product at latest valid in 2028. What is impact and reaction of intelligent manufacturer and all professionals in supply chains?

1. MDD products without renewal to MDR

So far not many authorities as Australia, UK and Swiss issued binding recognition of MDD and MDR products.

Let us start with countries without any evidence of “home country approval”. Register first all needed products before any limitation comes

Then let us limit the international markets to “free sales certificates” or declaration of conformity (DOC) as evidence for product registration. So far manufacturer can not save these expired MDD products. However if it was still in a valid international certificate, supply them early to local distributor. At the same time try to renewal these existing certificates which might need fewer documents or even a notification without home country approval evidence.

Solution

For manufacturer: Try to make early move for renewal of existing international certificates.

For distributor: Try to stock MDD products with valid certification before expiration.

2. MDD products without renewal to MDR, however with agreement with NB

Using Regulation (EU) 2023/607, MDD products can be placed still in EU market benefiting from transition time till latest 2028 depending on classification. The condition is to have an agreement with notified body. These products are also called legacy devices.

Manufactures should register all legacy devices soon using expired DOC combining agreement with notified body at international market. Even for application of FSC, both docu or at least DOC is needed. Apply many FSCs NOW as possible covering enough markets.

Solution

Alternative before and after deadline of these legacy devices, manufacturer could establish a new legal entity with production capacity or outsourced production to extend the international life of these products outside EU.

3. MDD products with valid DOC under MDR

Either manufacturer are waiting for MDR certification during the implementation, use the solution above profiting transition at 2023/607, or manufacturer have already DOC under MDR.

For international registration since the technical documentation is revised under MDR. For later case, we suggest manufacture to use new DOC and new version of technical documentation.

Impact: no delay of MDR product at international markets

4. Products up- or down (rarely) classified under MDR

Reclassification of medical device under MDR does NOT matter at international market if manufacturer has a valid DOC in case 2 or 3.

Otherwise manufactures has dealt with these new MDR products as initial registration at international markets. If basic TD e.g. risk management, device description and V&V reports are ready, there is no reason to wait for final DOC in EU for country without “home country approval”, prepare dossier for other markets, as US or Chinese (home country approval at submission needed) could go first.

5. Technical documentation under MDR

The regulatory affairs manager are fighting since 2017 MDR conform technical documentationeven only sampling dossier of high risk products are submitted and proved by notified body.

Summarised conclusion: technical documentation in EU matters to submission dossier at international markets only partly. If one revision of risk management file is ready for one product variant for e.g. Mexico registration, it could be used instead of waiting for next revision of RM.

Solution: The manufacture should match technical documentation international with one in EU. During the international registration, try to submit newest document.

6. MDR labelling

We can focus on product label, packaging label and instruction for use. They are undergoing diverse revisions. Actually it has no impact of international market.

Be careful with following scenarios:

Original labellings in EN and Labellings in local language are submitted: local labelling is deciding without inconsistent critical content to original labelling
Original labellings in EN are submitted: please release these labelling to imported medical device
Labellings in local language are submitted: take these local versions and back up a translation to subject language

Suggestion

Have a chat with authority whether labelling change is worthy to a change notification, then this kind of change of labelling within EU and international should be coordinated timely with all departments as QM, production, marketing, PM and RA.

7. Clinical data generated under MDR

There are not too many markets which need the extensive clinical evidence in EU. So manufacturer in EU with stringent clinical evaluation and Post Market Surveillance (PMS) can only benefit from arising international requirements. Be aware of international clinical guidance.

Positive impact of MDR

EU CER, PSUR or PMCF can be shortened or easily transferred to an international submission version.